- The Food and Drug Administration and Medtronic alerted healthcare providers of recent malfunctions identified with the company’s HeartWare Ventricular Assist Device (HVAD) System and provided recommendations for how to proceed with patients who currently have the pump implanted.
- Medtronic recently sent a letter to providers notifying them of a welding defect that caused devices to malfunction. According to Medtronic’s letter, an investigation into three devices that were returned suggested a welding defect allowed moisture to get into the device and disrupted the internal pump’s correct rotation. The medtech said that all three patients had a pump exchange. “One (1) patient was subsequently transplanted two months after the pump exchange and died one month later; one (1) additional patient died three weeks after the VAD exchange,” according to the company’s letter.
- The FDA does not recommend elective removal of the HVAD pumps, which is the same stance the agency had when the product was pulled from the market last June. “Discuss with patients that elective removal of an implanted Medtronic HVAD System is not recommended at this time. In general, the risks associated with explant outweigh the potential benefits,” the agency stated in its Thursday notice.
In June, the company pulled the system from the market. At the time, the product had piled up over a dozen Class I recalls as well as thousands of patient death and injury reports in the FDA’s medical device report database. The device also had a higher rate of malfunction reports than competing products from Abbott Laboratories, according to data analysis provided to MedTech Dive by the watchdog group ECRI.
When the decision was announced last year, Medtronic cited ongoing product issues and “a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System as compared to other circulatory support devices available to patients.”
Medtronic coordinated with rival Abbott to ensure that patients have an alternative device if needed.
In the April letter to providers, Medtronic said that all three devices investigated were manufactured between December 2017 and May 2018. The company said an “active investigation is in progress to identify which HVAD pumps may be affected” and it “will issue additional, detailed communication as soon as further information is available.”
All three patients that returned their pumps reported possible “pump thrombosis,” which is when blood clots in the device. Medtronic told providers the patients displayed symptoms or signs such as dizziness or lightheadedness, low motor speeds or abnormal pump sounds, like grinding or excess vibration, among others.
“Patients who present with one or more of the signs or symptoms of pump thrombosis should be first treated for pump thrombosis,” the FDA said. “If symptoms do not resolve, only then consider whether the patient is a candidate for pump exchange, heart transplant, or pump explant for recovery, considering the patient’s clinical condition and surgical risks.”
A Medtronic spokesperson said in an emailed statement that the letter went out to providers on April 27, and the company has “not received additional confirmed cases relating to recent pump weld defects” since the letter was sent. As of last June, there were approximately 4,000 patients with the pump implanted, according to Medtronic.
The HVAD saga recently caught the attention of Rep. Raja Krishnamoorthi, D-Ill., who sent a letter to the FDA in March asking for clarity about the regulation of the device.
“FDA is charged with ensuring patient access to safe, effective, and high-quality medical devices, but over multiple administrations the agency failed to protect consumers from the dangerous HVAD System,” wrote Krishnamoorthi, who is the chair of the House Subcommittee on Economic and Consumer Policy.
Medtronic has had ongoing product safety issues, with several Class I recalls already this year and numerous ones last year. Most recently, Medtronic initiated a Class I recall in March for the Puritan Bennett 980 series ventilators. It was the second Class I recall for the product in the last roughly six months; it also had Class I recalls in 2014, 2015 and 2018.
CEO Geoff Martha addressed the ongoing issue of recalls and patient safety problems at the J.P. Morgan healthcare conference in January, saying they were his “top priority.”