BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 19804063 · Received July 23, 2024

    Report

    Report Number
    2916596-2024-04609
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    April 2, 2024
    Report Date
    October 3, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4: UDI UPDATED. SECTION E2: HEALTH PROFESSIONAL: CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. NO PRODUCT WAS EVALUATED UNDER THIS COMPLAINT. THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION WERE REQUESTED BUT WERE NOT PROVIDED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE HEARTMATE 3 DEVICE SERIAL NUMBERS AS WELL AS OTHER SPECIFIC CASE/PATIENT INFORMATION ARE NOT AVAILABLE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. ALTHOUGH NO DEVICE RELATED ISSUES WERE REPORTED BY THE ACCOUNT, THE IFU LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT HAS BEEN ENTERED AS THE SAME AS PUBLISHED DATE ¿ 02APR2024 SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. DEVICE SERIAL NUMBER WAS NOT PROVIDED, AND EXPIRATION DATE CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. ARTICLE INFORMATION: SKOWRONSKI, JENNA; ET AL.. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, SUPPL. SUPPLEMENT83.13: 2818. ELSEVIER INC. (APR 2, 2024) HTTP://DX.DOI.ORG/10.1016/S0735-1097(24)04808-3 UNIVERSITY OF PITTSBURGH MEDICAL CENTER, PITTSBURGH, PA, USA. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RESEARCH ARTICLE TITLED ¿BRIDGING WITH BIVAD: OVERCOMING HIGH ALLOSENSITIZATION IN PERIPARTUM CARDIOMYOPATHY?¿ IDENTIFIED THAT HEARTMATE 3 IMPLANTED AS BIVENTRICULAR ASSIST DEVICE (BIVAD) OFFERED AN OPPORTUNITY TO BRIDGE TO TRANSPLANT WHILE UNDERGOING A DESENSITIZATION PROTOCOL AFTER PREGNANCY. IN PATIENTS WITH BIVENTRICULAR FAILURE, BIVAD IMPLANTATION MAY SERVE AS A BRIDGE TO HEART TRANSPLANT. THIS WAS A CASE STUDY OF A 38 YEAR OLD G1P0 FEMALE AT 31 WEEKS TWIN GESTATION WITH FAMILY HISTORY SIGNIFICANT FOR A SISTER WHO DIED AT AGE 39 FROM POSTPARTUM MYOCARDIAL INFARCTION PRESENTED WITH PRESUMED PERIPARTUM CARDIOMYOPATHY AFTER A MONTH OF SINUS TACHYCARDIA TO 140-150, DYSPNEA, ORTHOPNEA, AND EDEMA. LEFT VENTRICULAR EJECTION FRACTION WAS 10% WITH B-TYPE NATRIURETIC PEPTIDE (BNP) 1241, HIGH-SENSITIVITY TROPONIN (HSTROP) 61, AND LACTATE 1.7. GIVEN HER ELEVATED RISK, SHE UNDERWENT C-SECTION WITH SLOW EPIDURAL THAT PRECIPITATED HYPOTENSION AND SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS (SCAI) STAGE D CARDIOGENIC SHOCK WITH BEDSIDE POINT-OF-CARE ULTRASOUND (POCUS) LEFT VENTRICULAR EJECTION FRACTION (LVEF) 5%. SHE REQUIRED INTRAVENOUS EPINEPHRINE AND IMPELLA 5.5 IMPLANTATION. HUMAN LEUKOCYTE ANTIGEN (HLA) TESTING IDENTIFIED HIGH ALLOSENSITIZATION WITH CLASS I CALCULATED PANEL REACTIVE ANTIBODY (CPRA) OF 98%. SHE HAD NO EVIDENCE OF CARDIAC RECOVERY, BECAME FUNGAEMIC WITH CANDIDA ALBICANS, AND REQUIRED A TRACHEOSTOMY FOR RESPIRATORY FAILURE. DUE TO PERSISTENT RIGHT VENTRICULAR (RV) FAILURE, SHE WAS NOT ELIGIBLE FOR DURABLE LEFT VENTRICULAR ASSIST DEVICE (LVAD) ALONE. DUE TO PROGRESSIVE RV FAILURE, SHE WAS UPGRADED TO FEMORO-FEMORAL VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (V-A ECMO) SUPPORT ONE MONTH AFTER PRESENTATION. WITH FUNGEMIA CLEARANCE, SHE UNDERWENT HEARTMATE 3 BIVAD IMPLANTATION AND WAS DISCHARGED HOME. ULTIMATELY, SHE HAD A SUCCESSFUL HEART TRANSPLANT 11 MONTHS AFTER HER INITIAL PRESENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046118 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention