BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21978472 · Received May 7, 2025

    Report

    Report Number
    2916596-2025-03114
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 9, 2025
    Report Date
    April 23, 2026
    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
    MN, 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 ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO) COULD NOT BE CONFIRMED, AND A SPECIFIC CAUSE FOR THE REPORTED OBSTRUCTION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. FURTHER, REVIEW OF THE SUBMITTED LOG FILES CAPTURED THE PUMP FUNCTIONING AS INTENDED AT THE FIXED SPEED. NO UNUSUAL EVENTS OR ALARMS WERE NOTED. CT IMAGES WERE NOT PROVIDED FOR REVIEW. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE ACCOUNT. A CORRECTIVE AND PREVENTIVE ACTION WAS INITIATED TO FURTHER INVESTIGATE HEARTMATE 3 EOGO. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(6), WITH NO FURTHER EVENTS REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU )CAN BE FOUND ON THE ELECTRONIC IFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU, REV. D IS CURRENTLY AVAILABLE. 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, 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." NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXTRINSIC OUTFLOW GRAFT OBSTRUCTION WAS FOUND ON THE PATIENT'S COMPUTED TOMOGRAPHY (CT) SCAN. LOG FILES WERE SUBMITTED FOR REVIEW. THE EVENT LOG FILE CAPTURED MULTIPLE PULSATILITY INDEX (PI) EVENTS ON (B)(6) 2025 FROM 3:53:04 TO 8:08:11.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH MEDWATCH MW5184941 THAT THE PATIENT WAS FOUND TO HAVE AN EXTRINSIC OUTFLOW GRAFT OBSTRUCTION (EOGO) FOUND BY COMPUTED TOMOGRAPHY (CT) AND WAS ADMITTED FOR ELECTIVE LVAD OUTFLOW GRAFT OBSTRUCTION (OGO) RELEASE WITH A DOCTOR. SURGERY WAS A SUCCESS WITH A MODERATE/SEVERE AMOUNT OF PROTEINOUS MATERIAL EVACUATED FROM AROUND THE BEND RELIEF RESULTING IN IMPROVED LEFT VENTRICLE DECOMPRESSION AT LOWER LEFT VENTRICLE SPEEDS. THE PATIENT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249742 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 7305809 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1