BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19716849 · Received July 10, 2024

    Report

    Report Number
    2916596-2024-04249
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 21, 2024
    Report Date
    September 4, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4: PATIENT WEIGHT HAS BEEN CORRECTED. SECTION A4: PATIENT IDENTIFIER HAS BEEN CORRECTED. SECTION D4: UDI HAS BEEN CORRECTED. SECTION D4: SERIAL NUMBER HAS BEEN CORRECTED. SECTION D4: EXPIRATION DATE HAS BEEN CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION D4: LOT NUMBER CORRECTED. SECTION D6A: DATE OF IMPLANT CORRECTED. SECTION H4: DEVICE MANUFACTURE DATE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: BEND RELIEF DAMAGE WAS CONFIRMED THROUGH EVALUATION OF THE RETURNED BEND RELIEF; HOWEVER, IT WAS REPORTED THAT THE DAMAGE OCCURRED DURING FENESTRATION OF THE BEND RELIEF. THE BEND RELIEF WAS RETURNED IN TWO PIECES, SEVERED APPROXIMATELY 2.75¿ FROM ITS HARDWARE. PERFORATIONS IN THE BEND RELIEF CONSISTENT WITH THE REPORTED EVENTS WERE CONFIRMED, AND THE PLASTIC RING WAS EXPOSED AT ITS DISTAL END. TEARING WAS NOTED IN THE THIN OUTER LAYER OF THE BEND RELIEF, EXPOSING THE UNDERLYING LAYERS. THE PATIENT REMAINS ONGOING ON (B)(6) WITH NO FURTHER REPORTED ISSUES AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6), THE OUTFLOW ASSEMBLY, LOT #9117254, AND THE OUTFLOW GRAFT BEND RELIEF, LOT #8943827, WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) (REV. C) IS CURRENTLY AVAILABLE. SECTION 5 "SURGICAL PROCEDURES" CONTAINS INFORMATION REGARDING THE PREPARATION AND ATTACHMENT OF THE SEALED OUTFLOW GRAFT AND BEND RELIEF. SECTION 5 WARNS THAT DURING THE IMPLANT PROCESS, A COMPLETE BACKUP SYSTEM (IMPLANT KIT AND EXTERNAL COMPONENTS) MUST BE AVAILABLE ON-SITE AND IN CLOSE PROXIMITY FOR USE IN AN EMERGENCY. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE SERIAL NUMBER WAS NOT PROVIDED, AND EXPIRATION DATE CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM PROLONGED SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON MADE THE DECISION TO FENESTRATE THE BEND RELIEF USING AN 11 BLADE. THEY CREATED 4 SLICES IN BETWEEN PLASTIC RINGS, THEN USED AORTIC PUNCH TO CREATE HOLES. WHILE CREATING THE LAST HOLE WITH AORTIC PUNCH, THE SOFT PORTION OF THE BEND RELIEF SEPARATED FROM THE PLASTIC RING. DUE TO THE TEARING OF THE BEND RELIEF, THE SURGEON NEEDED TO CUT AWAY ABOUT AN INCH OF THE BEND RELIEF LEAVING AN EXPOSED PIECE OF PLASTIC RING. THEY DID NOT FEEL COMFORTABLE LEAVING IT IN PLACE, SO IT WAS DECIDED TO REPLACE THE BEND RELIEF. A NEW OUTFLOW GRAFT WAS OPENED, AND THAT BEND RELIEF WAS FENESTRATED WITHOUT USING THE AORTIC PUNCH. IT WAS SUCCESSFULLY FENESTRATED, AND NO OTHER ISSUES WERE NOTED DURING IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289803 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 10129120 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male