BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19568564 · Received June 19, 2024

    Report

    Report Number
    2916596-2024-03350
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    April 2, 2024
    Report Date
    June 19, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A: PATIENT INFORMATION WAS REQUESTED BUT NOT PROVIDED. B3: DATE OF EVENT ESTIMATED TO PUBLICATION DATE OF ARTICLE. D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. E1: (B)(6). AUTHOR CITATION: BETAGERI, O., ET AL. IMPELLA RP-ASSISTED VENTRICULAR TACHYCARDIA ABLATION AFTER A HEARTMATE 3 LEFT VENTRICULAR DEVICE IMPLANTATION COMPLICATED BY INCESSANT VENTRICULAR ARRHYTHMIAS. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 83(13), 3194. HTTPS://DOI.ORG/10.1016/S0735-1097(24)05184-2. MANUFACTURER¿S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION, INCLUDING PATIENT INFORMATION, WERE REQUESTED; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME. NO PRODUCT AVAILABLE FOR INVESTIGATION. THE SERIAL NUMBER OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM WAS NOT PROVIDED. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU)AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS ADVERSE EVENTS, INCLUDING RIGHT HEART FAILURE AND CARDIAC ARRHYTHMIA, THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ LISTS ARRHYTHMIA AS A POTENTIAL LATE POSTIMPLANT COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 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 IN THE ARTICLE ¿IMPELLA RP-ASSISTED VENTRICULAR TACHYCARDIA ABLATION AFTER A HEARTMATE 3 LEFT VENTRICULAR DEVICE (LVAD) IMPLANTATION COMPLICATED BY INCESSANT VENTRICULAR ARRHYTHMIAS¿ THAT A 62 YEAR-OLD MALE WITH HISTORY PRIOR TO LVAD IMPLANT OF NON-ISCHEMIC CARDIOMYOPATHY, BIVENTRICULAR ICD, CHRONIC KIDNEY DISEASE, PULMONARY HYPERTENSION, AND PERSISTENT ATRIAL FIBRILLATION PRESENTED WITH WORSENING HEART FAILURE SYMPTOMS. THE PATIENT DECOMPENSATED TO SCAI STAGE C/D SHOCK DESPITE MILRINONE, AND AN INTRAAORTIC BALLOON PUMP WAS PLACED AS A BRIDGE TO URGENT HEARTMATE 3 LVAD. THE POST-OPERATIVE COURSE WAS SIGNIFICANT FOR CARDIOGENIC SHOCK RELATED TO RIGHT VENTRICULAR DYSFUNCTION AND THE DEVELOPMENT OF INCESSANT MONOMORPHIC VENTRICULAR TACHYCARDIA (VT) REFRACTORY TO AMIODARONE AND LIDOCAINE INFUSIONS, STELLATE GANGLION BLOCKADE, AND MULTIPLE CARDIOVERSIONS. AFTER MULTIDISCIPLINARY DISCUSSIONS, AN IMPELLA RP-ASSISTED VT (VENTRICULAR TACHYCARDIA) ABLATION OF INFEROAPICAL VT (NEAR THE LVAD CANNULA SITE) WAS SUCCESSFULLY PERFORMED. THE PRIMARY SOURCE OF INCESSANT VT IN THIS CASE WAS RELATED TO THE CANNULA SITE. VT DID NOT OCCUR PRIOR TO LVAD PLACEMENT AND RESOLVED AFTER ABLATION IN THAT REGION. AMIODARONE WAS TRANSITIONED TO ORAL THERAPY, INOTROPY AND MECHANICAL SUPPORT WERE WEANED, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION ABOUT ONE WEEK FOLLOWING THE ABLATION. DEVICE WAS IMPLANTED AT TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677908 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT Ventricular (assist) bypass DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| L