BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14454242 · Received May 20, 2022

    Report

    Report Number
    2916596-2022-10879
    Event Type
    Death
    Date Received
    May 20, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 29, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), (B)(6), AND THE REPORTED CARDIAC ARRHYTHMIA COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS INVESTIGATION. (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 10.5 INCHES FROM THE PUMP HEADER. THE DISTAL PORTION OF THE PUMP CABLE AND THE MODULAR CABLE WERE NOT RETURNED. THE SEALED OUTFLOW GRAFT WAS RETURNED IN 2 PARTS, BOTH MEASURING APPROXIMATELY 3.5 INCHES. THE PROXIMAL PORTION OF THE SEALED OUTFLOW GRAFT WAS RETURNED ATTACHED TO THE PUMP COVER OUTLET PORT WITH THE BEND RELIEF ENGAGED TO THE GRAFT ATTACHMENT. THE APICAL CUFF WAS RETURNED SECURED WITH THE CUFF LOCK FULLY ENGAGED. UPON DISASSEMBLY OF THE RETURNED PUMP, VISUAL INSPECTION OF THE BLOOD-CONTACTING SURFACES DID NOT REVEAL ANY ADHERED DEPOSITIONS OR THROMBUS FORMATIONS. COAGULATED BLOOD WAS FOUND IN THE OUTFLOW GRAFT, PUMP OUTFLOW, PUMP COVER, AND ROTOR. THE LVAD EVENT AND PERIODIC LOG FILES RETRIEVED FROM THE RETURNED DEVICE APPEARED TO CAPTURE THE DEVICE FUNCTIONING AS INTENDED. (B)(6) 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 IMPLANT KIT WAS SHIPPED ON 21APR2022. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE LISTS CARDIAC ARRHYTHMIA AS AN ADVERSE EVENT, AS WELL AS A POTENTIAL LATE POSTIMPLANT COMPLICATION THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. 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 HAD RHYTHM DISTURBANCES PRIOR TO IMPLANT AND WERE CAUSED BY SEVERAL MEDICAL TREATMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT PASSED AWAY DUE TO MALIGNANT RHYTHM DISTURBANCE. THE PATIENT HAD RECURRENT VENTRICULAR TACHYCARDIA STORM AND VENTRICULAR FIBRILLATION. THE PATIENT WAS RECEIVING END STAGE MEDICAL THERAPY WITH HIGH DOSE AJMALINE AND AMIODARONE INTRAVENOUSLY. THE PATIENT WAS SHOCKED WITHOUT SUCCESS. THE DEATH WAS NOT BELIEVED TO BE DEVICE RELATED AND THE DEVICE WAS OPERATING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191280 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT 8240150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death