BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12964299 · Received December 8, 2021

    Report

    Report Number
    2916596-2021-06910
    Event Type
    Death
    Date Received
    December 8, 2021
    Date of Event
    October 28, 2021
    Report Date
    February 9, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), DID NOT REVEAL ANY DEVICE-RELATED ISSUES. A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED ISCHEMIC STROKE COULD NOT CONCLUSIVELY BE DETERMINED. (B)(6) WAS RETURNED WITH THE PUMP CABLE FULLY INTACT. A SEGMENT OF THE OUTFLOW GRAFT MATERIAL WAS RETURNED. THE GRAFT ATTACHMENT AND BEND RELIEF WERE NOT RETURNED. THE PUMP APPEARED TO HAVE BEEN EXPOSED TO A FIXATIVE PRIOR TO RETURN. UPON DISASSEMBLY OF THE RETURNED PUMP, VISUAL EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF ADHERED OR DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. VISUAL INSPECTION OF THE PUMP ROTOR AND ROTOR WELL DID NOT REVEAL ANY OBVIOUS SURFACE SCRATCHES OR DEFECTS. THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) EVENT AND PERIODIC LOG FILES RETRIEVED FROM THE RETURNED DEVICE APPEARED TO CAPTURE THE DEVICE FUNCTIONING AS INTENDED. MLP-024336 WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE LVAS KIT WAS SHIPPED ON 21OCT2021. THE HEARTMATE 3 LVAS IFU AND PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS STROKE AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 PROVIDES INFORMATION REGARDING ANTICOAGULATION, INCLUDING THE RECOMMENDED INR VALUES. CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION ARE PROVIDED IN VARIOUS SECTIONS OF THE IFU AND PATIENT HANDBOOK, INCLUDING CARING FOR THE DRIVELINE EXIT SITE AND CONTROLLING INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DIED DUE TO A MASSIVE ISCHEMIC STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856408 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524INT 7747225

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death