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U.S. Department of Health and Human Services

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

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HEARTWARE INC. HEARTWARE HVAD VENTRICULAR (ASSIST) BYPASS Back to Search Results
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.
 
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Brand NameHEARTWARE HVAD
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
HEARTWARE INC.
8200 coral sea street ne
mvs46
moundsview MN 55112
MDR Report Key14694892
MDR Text Key294014259
Report Number14694892
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
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 Received06/15/2022
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 Manufacturer12/30/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/23/2022
Event Location Hospital
Date Report to Manufacturer06/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/15/2022 Patient Sequence Number: 1
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