BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12161627 · Received July 13, 2021

    Report

    Report Number
    2916596-2021-03635
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    June 18, 2021
    Report Date
    August 26, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: NO DEVICE-RELATED ISSUES WERE IDENTIFIED DURING EVALUATION OF HEARTMATE 3 LVAS, (B)(6). (B)(6) WAS RETURNED ASSEMBLED WITH THE PUMP CABLE SEVERED APPROXIMATELY 8 INCHES FROM THE PUMP HEADER AND ANOTHER APPROXIMATELY 8-INCH INTERNAL SEGMENT WAS ALSO RETURNED. THE REMAINING PORTION OF THE PUMP CABLE AND THE MODULAR CABLE WERE NOT RETURNED. THE SEALED OUTFLOW GRAFT WAS RETURNED ATTACHED TO THE PUMP COVER OUTLET PORT. THE OUTFLOW GRAFT BEND RELIEF WAS RETURNED ATTACHED TO THE OUTFLOW GRAFT HARDWARE. THE APICAL CUFF WAS RETURNED WITH THE CUFF LOCK FULLY ENGAGED. UPON DISASSEMBLY OF THE RETURNED PUMP, EXAMINATION OF THE BLOOD-CONTACTING SURFACES REVEALED NO ADHERED DEPOSITIONS OR THROMBUS FORMATIONS. 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 PUMP FUNCTIONING AS INTENDED. MLP-013964 WAS CLEANED, REBUILT, AND FUNCTIONALLY TESTED ON A MOCK CIRCULATORY LOOP. THE DEVICE OPERATED AS INTENDED AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. REVIEW OF THE AVAILABLE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE IMPLANT KIT WAS SHIPPED TO THE CUSTOMER ON 26AUG2019. THE CURRENT REVISION OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE LISTS ADVERSE EVENTS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRANSPLANT WAS NOT DUE TO A DEVICE RELATED ISSUE. THE PATIENT WAS NOT ELEVATED ON THE TRANSPLANT LIST SECONDARY TO A DEVICE OR THERAPY RELATED ISSUE. THE DEVICE WAS OPERATING AS EXPECTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS TRANSPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055606 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7115217 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R