BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 13212080 · Received January 10, 2022

    Report

    Report Number
    2916596-2021-07718
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    April 19, 2021
    Report Date
    September 1, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED PATIENT CONDITIONS (NON-ISCHEMIC CARDIOMYOPATHY AND INTRAPERITONEAL DRIVELINE MALPOSITION) COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE (IFU) LISTS THE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 OF THE IFU "PATIENT CARE AND MANAGEMENT" CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW OF THE INFORMATION RECEIVED, THIS EVENT IS NOT REPORTABLE. THE PATIENTS DEVICE REVISION TOOK PLACE AS A RESULT OF A PATIENT FALL AND THE EVENTS DOCUMENT NO DEVICE MALFUNCTION OR ALLEGATION. THE DEVICE REVISION TOOK PLACE TO PROVIDE THE PATIENT WITH COMFORT AS THE FALL RESULTED IN DISPLACEMENT OF THE DRIVELINE CAUSING PAIN. THERE HAD BEEN NO PRE-FALL COMPLAINTS OF DRIVELINE PAIN OR DISCOMFORT. 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 PATIENT UNDERWENT A REVISION OF THEIR DRIVELINE VIA A LAPAROTOMY ON (B)(6) 2021. POST LVAD IMPLANT THERE WAS INTRAPERITONEAL MALPOSITION OF THE (B)(4) DRIVELINE AND NON-ISCHEMIC CARDIOMYOPATHY. WARFARIN WAS HELD WITH HOSPITAL ADMISSION ON (B)(6) 2021 AND RESUMED ON (B)(6) 2021 WITH A FONDAPARINUX BRIDGE THAT WAS STARTED ON (B)(6) 2021.

    Description of Event or Problem · 0

    THE PATIENT HAS A JAK 2 MUTATION AND A HISTORY OF HEPARIN INDUCED THROMBOCYTOPENIA SO THEY WEREN'T BRIDGED WITH ENOXAPARIN. THE DRIVELINE REVISION WAS REQUIRED DUE TO INTRAPERITONEAL DISPLACEMENT OF THE INITIAL LVAD PLACEMENT AFTER PATIENT COMPLAINED OF ABDOMINAL DISCOMFORT AFTER A FALL. A MEDIAN UPPER LAPAROTOMY AND EXTRAPERITONEAL TRANSPOSITION OF THE DRIVELINE WAS DONE USING THE COMPARTMENT SEPARATION TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642921 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7287717 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H