Is There No End to Medtronic’s HVAD Troubles?
There is yet another reported issue for the HVAD system, which has seen mounting problems since Medtronic acquired HeartWare in 2016.
Medtronic’s HVAD System is again at the forefront of another safety issue. In a communication on Nov. 29 from the company to its customers, Medtronic reported that the controller driveline cover of the HVAD System may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector.
The driveline cover slides over the pump and controller connector to protect it. The cover is first installed during HVAD implant and should cover the driveline connector unless a controller exchange is required. During the controller exchange process, the cover is pulled back from the connector onto the driveline cable. Following disconnection and reconnection of the driveline to a controller, the same cover is slid back into place over the connector.
If an urgent driveline connection or controller issue needs to be addressed, an inability or prolonged difficulty accessing the driveline connector could result in patient harm from pump stop over a longer period. The hardening issue, according to Medtronic, is due to plasticizer loss which may be accelerated by environmental factors. Plasticizer is what keeps the cover material soft and malleable.
The company reported that it received 33 complaints between Jan. 3, 2017, and Sept. 15, 2022, that there was a hardening or stuck driveline cover. In all observed complaints, the issue happened after multiple years of use and required servicing or additional tools to remove a hardened cover. In 25 of the events, negligible or no patient harm was reported, four events had patients who were hospitalized for unrelated reasons, the last four events of the 33 reported included the hardened driveline cover being identified during routine clinic visit or following a controller alarm. Those four patients were hospitalized to service and remove the driveline cover. No critical harm or deaths have been attributed to this issue.
This is just the latest issue reported by Medtronic about the HVAD System, which has seen an ongoing wave of recalls and safety issues over the years since the company inherited the device in the acquisition of HeartWare in 2016. Even before the acquisition, HeartWare recalled, in 2015, more than 18,000 batteries ventricular assist devices sold between 2013 and 2015. The Class I recall was due to the batteries losing power prematurely because of faulty cells.
A month after the acquisition, the HVAD system was again involved in two significant recalls. One recall involved 8,799 HVAD controllers that were potentially damaged from exposure to moisture through looser power and data connectors. The second recall involved 350 unimplanted kits sitting in hospital inventory that were reported as susceptible to electrical faults and connection failure from fluid entering the connector.
In 2018, Medtronic recalled 204,017 devices because of an issue stemming from an interruption of the electronical connection between the power source and HVAD controller. In May of 2020, another issue was announced with the device that resulted in a recall of its outflow graft and outflow graft strain relief. This recall was because of risks of breaks and tears of during the pre-implant pump assembly process.
In March 2021, Medtronic recalled the HVAD pump implant kit due to a fail to initially start, restart, or a delay in restarting after the pump stops. While the recall was started by the company in November or 2020, the FDA didn’t highlight the recall until early March after two deaths and many serious injuries were reported.
Then in June of 2021, the plug was finally pulled on the sale and distribution of the system. Physicians were also notified to cease new implants using HVAD. At the time, Medtronic announced the development of a support program for patients with a HVAD implanted, along with caregivers and healthcare professionals who participate in the care of patients with the system.
Now, that support program seems to be fulfilling its mandate in spades in light of the newly surfaced issue. The company stated in the urgent medical device communication that patients and clinicians are not to repair or service any components of the HVAD system and to contact an authorized Medtronic representative to perform driveline cover serving. Additionally, any adverse reaction or quality problems with the HVAD System can be reported to the FDA’s MedWatch Adverse Event Reporting program.
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