MAUDE Adverse Event Report: HEARTWARE INC. HEARTWARE HVAD; VENTRICULAR (ASSIST) BYPASS

Device Problems Corroded (1131); Moisture Damage (1405); Output Problem (3005)

Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Multiple Organ Failure (3261); Thrombosis/Thrombus (4440)

Event Date 12/20/2021

Event Type  Death  

Event Description

Patient with history of non-ischemic cardiomyopathy and systolic heart failure who was treated with left ventricular assist device (lvad) (heartware hvad) implantation and aortic valve replacement early 2019.Towards the end of 2021, patient developed signs of pump thrombosis (increasing power reports, dark urine, elevated plasma free hemoglobin and lactate dehydrogenase) necessitating consideration for pump replacement.The two choices for care were to proceed with high risk pump replacement or to choose palliative care/hospice.Patient proceeded with pump replacement.Medtronic hvad was replaced with an abbott heartmate 3 (hvads are no longer manufactured) and developed significant bleeding requiring transfusion of multiple blood products, right heart failure requiring temporary mechanical support with an impella p7, a return to the or for bleeding/washout and high vasopressor requirements.Patient went on to develop multi-organ dysfunction and bacteremia.Goals of care discussions with family led to decision to withdraw life-prolonging interventions and he died early 2022.The hvad was returned to medtronic for analysis following pump exchange.In april 2022 we were notified by medtronic that they had received 3 complaints of patients with suspicion of pump thrombosis and had identified a device malfunction upon inspection of the 3 returned pumps.Wear marks indicated that the impeller was rotating non-concentrically and contacting the center post of the pump.The investigation suggested this was caused by a weld defect that allowed moisture into the center post and corroded the magnets.

• Brand Name: HEARTWARE HVAD
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE INC.; 8200 coral sea street ne; mvs46; moundsview MN 55112
• MDR Report Key: 14694892
• MDR Text Key: 294014259
• Report Number: 14694892
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 28105 DA
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White