BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 22329790 · Received June 25, 2025

    Report

    Report Number
    2916596-2025-03933
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    April 1, 2025
    Report Date
    July 24, 2025
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A AND D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. DEVICE WAS IMPLANTED AT TIME OF EVENT. SECTION B3: DATE OF EVENT HAS BEEN ENTERED AS THE DATE OF PUBLICATION 01APR2025 SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. AUTHOR INFORMATION: BAYLOR UNIVERSITY MEDICAL CENTER, PLANO, TX, USA. ASSAF, A., SALIH, M., & POTLURI, S. P. (2025). MECHANICAL SYNCOPE: A UNIQUE CASE OF AN LVAD REQUIRING OUTFLOW TRACT INTERVENTION. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 85(12), 4583. HTTPS://DOI.ORG/10.1016/S0735-1097(25)05067-3. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    E1 - REPORTER ESTABLISHMENT NAME - CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) SERIAL NUMBER MLP-035261, AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LVAS, SERIAL NUMBER MLP-035261, AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MLP-035261 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS CARDIAC ARRYTHMIA, AND HYPERTENSION AS A POTENTIAL ADVERSE EVENT WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. 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. THIS SECTION 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 6, "PATIENT CARE AND MANAGEMENT", ALSO LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. SECTION 6, ¿PATIENT CARE AND MANAGEMENT,¿ STATES THAT ¿POST-IMPLANTATION HYPERTENSION MAY BE TREATED AT THE DISCRETION OF THE ATTENDING PHYSICIAN. ANY THERAPY THAT CONSISTENTLY MAINTAINS MEAN ARTERIAL BLOOD PRESSURE LESS THAN 90 MM HG SHOULD BE CONSIDERED ADEQUATE.¿ NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE ARTICLE, ¿MECHANICAL SYNCOPE: A UNIQUE CASE OF AN LVAD REQUIRING OUTFLOW TRACT INTERVENTION¿ THAT A 72 YEAR OLD MALE PRESENTED FOR RECURRENT PRE-SYNCOPAL SYMPTOMS INCLUDING DIZZINESS WHICH WAS WORSE WITH AMBULATION; THEY HAD A HISTORY OF ISCHEMIC CARDIOMYOPATHY STATUS POST HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) PLACEMENT, VENTRICULAR TACHYCARDIA STATUS POST IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) PLACEMENT AS WELL AS SOTALOL, METOPROLOL AND MEXILETINE TREATMENT, HYPERTENSION AND HYPERLIPIDEMIA. THE PATIENT WAS ADMITTED FOR SEVERAL DAYS AND HAD THEIR LVAD SPEED INCREASED TO 6100 RPM WHICH LED TO AN IMPROVEMENT IN SYMPTOMS. THE PATIENT UNDERWENT A 4-DIMENSIONAL CARDIAC COMPUTED TOPOGRAPHY OF THEIR LVAD WHICH SHOWED A HOMOGENOUS HYPOATTENUATION NEXT TO THE BEND RELIEF PORTION OF THE OUTFLOW CANNULA WHICH REPRESENTED BIODEBRIS ACCUMULATION; THIS WAS FELT TO BE NON-SIGNIFICANT. THE PATIENT RETURNED FOR SIMILAR SYMPTOMS SEVERAL DAYS LATER INCLUDING SYNCOPE. THEY WERE TAKEN TO THE CARDIAC CATHETERIZATION LABORATORY FOR RIGHT AND LEFT HEART CATHETERIZATION WHICH SHOWED LUMINAL NARROWING OF AT LEAST 50% OF THE OUTFLOW TRACT CANNULA WHICH WAS CONFIRMED WITH INTRAVASCULAR ULTRASOUND. THE DECISION WAS MADE BY ELECTROPHYSIOLOGY, NEUROLOGY, AND ADVANCED HEART FAILURE TEAMS TO PLACE A 11MM X 59MM COVERED STENT IN THE AREA OF THE NARROWING. THERE WAS IMPROVEMENT IN THE LUMINAL GAIN AFTER THE STENT WAS PLACED. IT WAS NOTED THAT ACCUMULATION OF BIODEBRIS AND LOW-GRADE STENOSIS OF LVAD OUTFLOW CANNULAS WERE COMMONLY ENCOUNTERED FINDINGS FOLLOWING DEVICE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142654 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8699198 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H