The Fridley, Minn.-based company’s HVAD heart pump has an outflow graft that may be subject to tears, and its strain relief screw may break during the pre-implant pump assembly and attachment to the HVAD pump.
Medtronic said in the notice that it is offering additional steps for assembly and attachment to reduce the risk of tears and damage. No action is needed for patients who are currently implanted with an HVAD pump because the potential for damage applies to the pre-implant outflow graft and strain relief assembly procedure, so the company is not retrieving the product from the field.
Affected products include the HVAD pump outflow graft, model number 1125, HVAD pump implant kit, model number 1104, and the HVAD implant accessories kit, model number 1153.
The company received 92 complaints related to the issue after distributing nearly 22,000 HVAD pumps through March 5, 2020. In total, Medtronic reported two deaths associated with the outflow graft tears and two deaths related to subsequent complications after outflow graft intervention.
Medtronic received 54 total complaints related to the outflow graft tears, which can result in peri-operative and post-operative bleeding. The company also received 38 complaints related to the broken strain relief screws with no reported patient harm in relation to that particular issue. Product damage was identified prior to or during implant in 74 cases and post-implant in 18 cases.
The company said it is working with regulatory agencies for approval of a design change that is intended to reduce the risk of damage related to these issues and will provide training on the change after approval is obtained. Users are urged to closely inspect the graft after assembly and before implantation, while physicians were instructed to practice standard peri-operative and immediate post-operative patient management to detect for the issue.