BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 15349087 · Received September 2, 2022

    Report

    Report Number
    2916596-2022-13528
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 10, 2022
    Report Date
    March 10, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Removal / Correction Number
    FA-Q124-HF-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE ACCOUNT¿S SUBMITTED IMAGES CONFIRMED THE REPORTED EXTRINSIC OUTFLOW GRAFT (OFG) OBSTRUCTION. A SPECIFIC CAUSE FOR THE OBSTRUCTION COULD NOT BE DETERMINED THROUGH THIS INVESTIGATION. FOUR IMAGES WERE SUBMITTED BY THE ACCOUNT FOR EVALUATION. THE FIRST IMAGE SHOWED A COMPUTED TOMOGRAPHY (CT) SCAN OF THE OUTFLOW GRAFT THAT APPEARED TO BE COMPRESSED DUE TO BIOMATERIAL THAT WAS PRESENT BETWEEN THE OFG AND OFG BEND RELIEF. THE REMAINING THREE IMAGES SHOWED THE BEFORE, DURING, AND AFTER OF THE PATIENT¿S OFG REVISION PROCEDURE. A PORTION OF THE OFG BEND RELIEF APPEARED TO HAVE BEEN REMOVED. THE CONTROLLER EVENT LOG FILE CONTAINED DATA FROM 10AUG2022 THROUGH 30AUG2022. NO NOTABLE EVENTS OR ALARMS WERE CAPTURED, AND THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE SET SPEED. THE PATIENT REMAINS ONGOING ON HM3 LVAS, SERIAL NUMBER (B)(6), AND NO FURTHER EVENTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE 3 LVAS IFU, AND THE HEARTMATE 3 PATIENT HANDBOOK, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, ¿INTRODUCTION¿, ADDRESSES ALL PUMP PARAMETERS. SECTION 5 OF THE IFU, ¿SURGICAL PROCEDURES¿, OUTLINES CONSIDERATIONS FOR PUMP PLACEMENT AND PROVIDES INSTRUCTIONS REGARDING THE PREPARATION, INSTALLATION, AND ORIENTATION OF THE SEALED OUTFLOW GRAFT. SECTION 5, UNDER "ATTACHING THE SEALED OUTFLOW GRAFT TO THE PUMP," INSTRUCTS THE USER TO VERIFY THAT THE GRAFT IS NOT TWISTED OR KINKED BY CHECKING THE POSITION OF THE BLACK LINE ON THE GRAFT ABOVE AND BELOW THE BEND RELIEF AND ENSURING THAT THE LINE IS STRAIGHT. SECTION 5 OF THE IFU, UNDER "PREIMPLANT PROCEDURES" AND "IMPLANT PROCEDURES" CAUTIONS THE USER: "THE SEALED OUTFLOW GRAFT MUST NOT BE KINKED OR POSITIONED WHERE IT COULD ABRADE AGAINST A PUMP COMPONENT OR BODY STRUCTURE" AND "STRETCH THE SEALED OUTFLOW GRAFT COMPLETELY PRIOR TO MEASURING AND CUTTING THE GRAFT TO THE APPROPRIATE LENGTH." SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING¿, AND SECTION 7 OF THE IFU, ¿ALARMS AND TROUBLESHOOTING¿, PROVIDES INFORMATION ON ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. A SECTION ON ¿HANDLING EMERGENCIES¿ IS ALSO PROVIDED IN THE PATIENT HANDBOOK. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CONCERN FOR OUTFLOW GRAFT (OFG) OBSTRUCTION. THE PUMP PARAMETERS WERE IN RANGES EXPECTED TO BE SEEN FOR A SET SPEED OF 7000 RPM. IT DID NOT APPEAR TO BE HAVING MUCH EFFECT ON THE PUMP PARAMETERS AT THIS TIME IF THERE WAS AN OBSTRUCTION. IT WAS ALSO NOTED WHEN THE SET SPEED WAS TEMPORARILY INCREASED TO 7800 RPM ON (B)(6) 2022 THE FLOW DID NOT INCREASE MUCH. THE PATIENT HAD ELEVATED FILLING PRESSURES, AN ENLARGED LEFT VENTRICLE AND A COMPUTED TOMOGRAPHY (CT) SCAN THAT SHOWS COMPRESSION OF THE OFG. THE PATIENT WAS SCHEDULED FOR A OFG REVISION.

    Description of Event or Problem · 0

    THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) ON (B)(6)2022 FOR OFG REVISION. THE SURGEON REMOVED A LARGE PORTION OF THE BEND RELIEF AND REMOVED BIOLOGICAL DEBRIS FROM AROUND THE OFG. THE PATIENT¿S FLOWS INCREASED IMMEDIATELY AFTER CLEANING OUT AROUND THE OFG. PER ECHOCARDIOGRAM (ECHO), THE PATIENT¿S LEFT VENTRICLE DIMENSION IMPROVED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268999 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7103751 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Hospitalization| R