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On April 26, the FDA announced that Medtronic's Harmony's catheterized pulmonary valve (TPV) catheter system is listed as a Class I recall, the most serious recall level, meaning the device could cause serious injury or death.
The Harmony transcatheter pulmonary valve (TPV) system, the world's first self-expanding pulmonary valve, was recognized by the FDA as a "breakthrough device," accelerating its approval. The device received FDA approval in March 2021.
However, just one year after its approval, Medtronic initiated an active recall of harmony's catheterization system for the transcatheter pulmonary valve (TPV) on March 2, 2022, affecting a total of 665 devices distributed in the United States between April 7, 2021 and January 26, 2022.
To date, six complaints of clinical cases have been reported, with a total of one injury and zero deaths related to equipment use.
01
The equipment is at risk of breaking
Use will be suspended
Transcatheter pulmonary valve replacement (TPVR) was first pioneered in 2000 to treat patients with right ventricular outflow tract insufficiency (including stenosis and reflux) complicated by right ventricular outflow tract reconstruction, and as with TAVR, minimally invasive implants can delay open surgery and improve long-term prognosis in such patients.
Although TPVR was first introduced, it was affected by the number of patients, indications, durability and promotion value, and its development lagged behind that of TAVR.
Harmony Transcatheter Pulmonary Valve (TPV) is the world's first self-expanding pulmonary valve, and the previously marketed TPVR products were mainly balloon dilation valves, such as Medtronic's Melody and Edward's Sapien.
The balloon dilation valve model is small and is not suitable for the anatomical characteristics of RVOT with neoplastic expansion due to long-term PR, which further leads to limited use of TPVR.
Harmony's approval not only solves the problem of the small balloon dilation valve model, but also gives Medtronic the lead over Edwards in TPVR, whose products are still in clinical research.
However, only one year after the approval of the world's first, on March 2, 2022, Medtronic launched a recall of Harmony's catheter delivery system on the grounds that the adhesive that fixed the capsule to the end of the conveyor catheter could break during the placement of the TPV.
Rupture may result in delayed surgery or additional surgery arrangements. Once a rupture occurs during surgery, it can cause serious harm to the patient. These risks include: blocking blood flow and/or complete obstruction (embolism or occlusion), tearing and/or splitting (perforation or dissection), or other types of damage to the patient's blood vessels.
Recall product batches
There are currently a total of 6 complaints from clinical cases, one injury, and no deaths related to the use of these devices.
According to the FDA's relevant recall page, 665 devices affected by the recall were distributed in the United States from April 7, 2021 to January 26, 2022.
What is affected is:
1. Healthcare workers who plan to implant Harmony TPV into patients with severe pulmonary valve reflux
2. Candidates for valve replacement using the Harmony TPV system
Medtronic also specifically noted that the recall only applies to the delivery catheters of the Harmony TPV, not the Harmony TPV. For patients who have successfully implanted Harmony TPV, no action is required.
On April 6, 2022, Medtronic issued an emergency medical device recall notice to implant physicians and customers, recommending an immediate suspension of the use of Harmony TPV's delivery catheters.
Note to customers include:
1. Remove the catheter from all unused products and return it to Medtronic.
2. Suspension of new implanted cases of harmony TPV system.
3. The customer is also asked to fill out a form with a letter to confirm receipt of the recall and report the number of unused devices currently on hand.
Device House reviewed the FDA page and found that a total of 1483 Harmony TPV systems have been distributed in the United States and Canada, and it is unclear whether the recall will be extended to all products, as well as some of them for sale in Canada.
02
Medtronic traps The Class I recall gate
China is greatly affected
In the past two years, Medtronic has been frequently involved in Class I recalls, making it difficult to distinguish whether it is old news or news.
Stent fractures killed and the diabetes business suffered a crush
According to the FDA's database, Medtronic has 10 recalls in 2021 classified as Class I.
Among them, valiant Navion chest stent transplant system had an extremely rare clinical accident "stent rupture", and three patients had stent fracture in the "Valiant Evo Global Clinical Trial" of the device, two of whom had fibrous tube tears, blood leaked into the aorta, and caused the death of one subject.
The MiniMed insulin pump is a core product of Medtronic's diabetes business, and the recall of this product has also caused major trouble for Medtronic.
MiniMed 670G
In October 2021, Medtronic expanded its recall of the MiniMed 508, the remote control of the Paradigm pump, and the MiniMed 600 series pump, both of which are Class I recalls and are at risk of serious injury or death. The recall has severely impacted Medtronic's diabetes business.
In December 2021, Medtronic received a warning letter from the FDA and was named for failing to handle the recall of insulin pumps and remote controls. In order to deal with the related problems, the approval of Medtronic's new insulin pumps and CGM products was further delayed, and the diabetes business was once again hit hard and immediately reacted to the market. Once the warning letter was made public, Medtronic's stock price fell more than 11% to $99.53 in a matter of days.
The 2021 recall also involved Chinese products on several occasions.
In December 2021, the NmPA announced that Medtronic's Covidien division had initiated a first-level recall of Pulitan Bennet 980 series ventilators due to manufacturing errors.
On November 18, 2021, the NmPA issued a number of Medtronic recalls, including the insulin syringe pump Insulin Pump and the Endurant II Stent Graft System for the laminated stent system as first-level recalls.
"Life-saving artifact" first-level recall, accounting for 50% of China
With the arrival of the 2022 New Year, Medtronic's recall has not come to an end.
Just one month into the year, Medtronic was involved in four Class I recalls, including:
Covidien's PurenBennett 980 series ventilators, Synergy Cranial, Stealth Station S7 Cranial software and HawkOne directional excision system
However, just when everyone was not surprised by the recall, this first-level recall involved 50% of China's products.
In March 2022, NMPA announced that Medtronic had decided to conduct a primary recall of the Ultracorporeal Blood Pumping Console product, the (ECMO) centrifugal pump blood control monitoring system.
Documents show that this failure may cause the instrument to shut down, including the interface becomes black, the equipment smokes, and there is a burning smell during use.
Industry insiders interpret that for ECMO machines, the black screen or the situation of blood pump stopping means that the machine cannot normally simulate human blood circulation. Although the probability is not high, the results are extremely serious.
The recall involves 263 units produced (imported) in China, while the current number of DOMESTIC ECMO is only about 500 units, and the equipment involved in Medtronic's recall accounts for almost half of the equipment.
ECMO Chinese extracorporeal membrane oxygenation, in addition to temporarily replacing the patient's cardiopulmonary function, reducing the patient's cardiopulmonary burden, such as respiratory failure, cardiac arrest and other conditions, so it is also known as a "life-saving artifact".
China's ECMO product deployment is originally insufficient, and ECMO is the key medical equipment urgently needed in the current epidemic prevention and control, it can be said that the recall has a great impact on China's medical system.
03
Business growth slowed
Previously, Medtronic released global earnings data for fiscal 2021 (FY21 cycle from April 25, 2020 to April 30, 2021).
According to the data, Medtronic reported revenue of $30.117 billion in fiscal year 2021, with reported revenue up 4% and organic growth of 2%.
Among them, the specific financial performance of the four major sectors is:
The cardiovascular business achieved revenue of $10,772 million, an increase of 2.9% year-on-year, the surgery and critical care business achieved revenue of $8,737 million, an increase of 4.6%, the neuroscience business achieved $8,195 million, an increase of 6.1% year-on-year, and the diabetes business achieved $2,413 million, an increase of 1.9% year-on-year.
*Medtronic FY2021 runs from April 28, 2020 to April 28, 2021.
Combined with recent earnings reports from other companies, the global cardiovascular big four rankings remain unchanged: Medtronic first, Abbott second, Boston Scientific third, and Edward Life Sciences fourth.
Although Medtronic still occupies the first place in the cardiovascular field, the growth rate is significantly weakened, the lowest among the four companies.
Fiscal 2021 is also Geoff Martha's first year as Medtronic Global CEO, and in the last quarter of fiscal 2021, Medtronic sought change by adjusting its cardiovascular business structure, including heart rhythms and heart failure, structural heart disease, aorta, coronary arteries and peripheral blood vessels.
The cardiovascular business is Medtronic's earliest start-up, longest-running business, and the highest revenue segment. Revenue in this segment fell 9% in fiscal 2020, and the decline in performance did not change in fiscal 2021.
Screenshot from Medtronic earnings report
As a lesson in the past, Medtronic Diabetes revenue of $1.741 billion in the first three quarters of fiscal year 2022 (ending January 28, 2022), down 1.4% year-on-year, was the only business segment in Medtronic that declined due to the insulin pump recall.
The recall of Harmony's catheterization system for the transcatheter pulmonary valve (TPV) has sounded another wake-up call for Medtronic's cardiovascular plate. However, as the world's first self-expanding pulmonary valve, the innovative value of this product is still worthy of recognition.
Previous clinical studies of the Harmony transcatheter pulmonary valve (TPV) have also shown excellent safety (no mortality) and efficacy.
In a prospective, non-randomized, multicenter clinical study, 70 patients were implanted with Harmony. All patients were planned to be followed up at the start of the study, at implant surgery, at one, six, and five years after implantation.
Within 30 days of Harmony implantation, the primary safety endpoint was no surgery or instrument-related death, achieved in 100% of patients. And there were no significant re-interventions, re-surgeries, or endocarditis at 6 months. At the same time, among patients with assessable echocardiogram, 89.2% achieved the primary efficacy endpoint.
After Harmony was approved, the study was delayed to 10 years in order to provide Harmony's long-term durability, safety and efficacy.
Medical devices are directly related to the safety of the human body, so their innovation process and marketing are particularly difficult. Will the impact of this recall expand in the future? The Appliance House will continue to pay attention.
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