BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 16644616 · Received March 30, 2023

    Report

    Report Number
    2916596-2023-01866
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 26, 2023
    Report Date
    April 12, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURE¿S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILE CONFIRMED EVENTS THAT APPEARED CONSISTENT WITH A POTENTIAL ISSUE WITH THE DRIVELINE (DL); HOWEVER, A SPECIFIC CAUSE FOR THESE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED X-RAY IMAGES OF THE DL WERE REVIEWED AND DID NOT APPEAR TO REVEAL ANY SPECIFIC AREAS OF CONCERN. THE SUBMITTED LOG FILE CONTAINS DRIVELINE FAULT ALARMS THROUGHOUT THE CAPTURED EVENTS FROM (B)(6) 2023. IN ADDITION, LOW SPEED AND PUMP STOP EVENTS WERE ALSO CAPTURED ON (B)(6) 2023 WHILE THE PATIENT WAS SUPPORTED BY EXTERNAL BATTERY POWER. THE PATIENT REMAINS ONGOING ON HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) AND THE DRIVELINE/DRIVELINE REPAIR WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER PUMP PERFORMANCE MONITORING), COVERS WEAR AND TEAR TO THE PERCUTANEOUS LEAD. SECTION 7, ¿ALARMS AND TROUBLESHOOTING,¿ ADDRESSES ALL SYSTEM CONTROLLER ALARMS AND HOW TO RESPOND TO SUCH EVENTS. THE HEARTMATE II LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. THE PATIENT HANDBOOK CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE¿; HOWEVER, ALL HEARTMATE II LVAS DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE AND PATIENT HANDLING. 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 WAS ADMITTED WITH CHEST PAIN DUE TO A PUMP STOP, LOW FLOW AND DRIVELINE FAULT ALARMS. THE PATIENT WAS PUT ON AN UNGROUNDED CABLE AND X-RAYS WERE TAKEN. THERE WERE NO OBVIOUS AREAS OF CONCERN IN THE IMAGES AND THE DRIVELINE WAS WITHOUT NEW TEARS OR KINKS. THE LOG FILES NOTED DRIVELINE FAULT EVENT AND SEVERAL PUMP STOPS ON BATTERY POWER ON (B)(6) 2023. THE DRIVELINE WIRE DATE SHOWED THAT THE MONITORED WIRE IN PHASE 3 MAY BE COMPROMISED AS WELL AS A PHASE TO PHASE SHORT. AS OF (B)(6) 2023 THE PATIENT HAS NOT HAD ANY FURTHER PUMP STOPS AND OPTIONS WERE BEING DISCUSSED WITH PALLIATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211218 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 6128604 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization