BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 21891839 · Received April 23, 2025

    Report

    Report Number
    2916596-2025-02299
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    August 6, 2024
    Report Date
    May 20, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FROM THE DIVISION OF CARDIOLOGY, DEPARTMENT OF MEDICINE, MAZANKOWSKI ALBERTA HEART INSTITUTE, FACULTY OF MEDICINE AND DENTISTRY, UNIVERSITY OF ALBERTA, EDMONTON, ALBERTA, CANADA. SADASIVAN, C., GAGNON, L. R., MA, C. H., DION, J., KIM, D. H., & OUDIT, G. Y. (2025). ADVANCED BIVENTRICULAR HEART FAILURE PRECIPITATED BY LARGE TERRITORY STROKE IN A PATIENT WITH CARVAJAL SYNDROME. JACC: CASE REPORTS, 30(5), 103191. HTTPS://DOI.ORG/10.1016/J.JACCAS.2024.103191 . NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION B2: OUTCOMES ATTRIBUTED TO ADVERSE CORRECTED. SECTION B3: DATE OF EVENT CORRECTED. SECTION D6A: DATE OF IMPLANT CORRECTED. SECTIONS E2 AND E3: CORRECTED. SECTION G2: REPORT SOURCE CORRECTED. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO FURTHER RELATED EVENTS HAVE BEEN 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 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE IFU ARE CURRENTLY AVAILABLE. SECTION 1 OF THIS IFU LISTS POTENTIAL ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE, THAT MAY BE ASSOCIATED WITH THE USE OF THE HM3 LVAS. SECTION 6 "PATIENT CARE AND MANAGEMENT" (UNDER "RIGHT HEART FAILURE") DISCUSSES THE POTENTIAL DEVELOPMENT OF RIGHT HEART FAILURE FOLLOWING IMPLANT AND OUTLINES THE ASSOCIATED TREATMENT OPTIONS, INCLUDING INOTROPES AND RIGHT VENTRICULAR ASSIST DEVICE (RVAD) PLACEMENT. SECTION 6 (UNDER CAUTION!) STATES: "RIGHT HEART FAILURE CAN OCCUR FOLLOWING IMPLANTATION OF THE PUMP. RIGHT VENTRICULAR DYSFUNCTION, ESPECIALLY WHEN COMBINED WITH ELEVATED PULMONARY VASCULAR RESISTANCE, MAY LIMIT THE EFFECTIVENESS OF THE LVAS DUE TO REDUCED FILLING OF THE PUMP." 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 'ADVANCED BIVENTRICULAR HEART FAILURE PRECIPITATED BY LARGE TERRITORY STROKE IN A PATIENT WITH CARVAJAL SYNDROME' THAT A 25 YEAR OLD MAN WITH CARVAJAL SYNDROME EXPERIENCED A STROKE THAT LED TO RESIDUAL EFFECTS AND DEVELOPMENT OF HEALTH COMPLICATIONS. THE MANIFESTATIONS OF THE PATIENT'S CARVAJAL SYNDROME INCLUDED ARRHYTHMOGENIC DILATED CARDIOMYOPATHY. THE PATIENT HAD A RIGHT-SIDED HEART CATHETERIZATION DURING A HEART FAILURE ADMISSION WHICH DEMONSTRATED GROUP 2 PULMONARY HYPERTENSION, SIGNIFICANTLY ELEVATED RIGHT AND LEFT FILLING PRESSURES, AND ASSOCIATED LOW CARDIAC OUTPUT. GIVEN THE RIGHT-SIDED HEART CATHETERIZATION FINDINGS AND CONTINUED CLINICAL DETERIORATION, VENTRICULAR ASSIST DEVICE AS A BRIDGE TO CANDIDACY/TRANSPLANTATION WAS SCHEDULED. HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) INSERTION WAS PERFORMED AND THE LV WAS ALSO CLOSELY INSPECTED INTRAOPERATIVELY FOLLOWED BY SURGICAL REMOVAL OF THE RESIDUAL LV THROMBUS. THE LVAD INSERTION WAS COMPLICATED BY RV FAILURE INTRAOPERATIVELY. AS THE CARDIOPULMONARY BYPASS CIRCUIT WAS BEING WEANED OFF, THERE WAS EVIDENCE OF SIGNIFICANT RV DYSFUNCTION WHICH REQUIRED SIGNIFICANT INOTROPE AND VASOPRESSOR SUPPORT, INCLUDING ADDITIONAL BOLUSES OF EPINEPHRINE TO MAINTAIN HIS HEMODYNAMICS. DUE TO ONGOING HEMODYNAMIC INSTABILITY DESPITE SIGNIFICANT VASOPRESSOR/INOTROPIC SUPPORT AND POOR RV FUNCTION AT BASELINE, THE DECISION WAS MADE TO IMPLANT A RIGHT VENTRICULAR ASSIST DEVICE (RVAD) CENTRIMAG. HE WAS QUICKLY WEANED OFF PRESSORS AND INOTROPES POSTOPERATIVELY IN THE CARDIOVASCULAR INTENSIVE CARE UNIT. RVAD WAS SLOWLY AND SUCCESSFULLY WEANED OVER THE NEXT MONTH AND THEN DECANNULATED. FOLLOWING RVAD DECANNULATION, THIS PATIENT UNDERWENT SIGNIFICANT REHABILITATION BEFORE EVENTUAL DISCHARGE HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291936 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 10288713 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Required Intervention| L