BEUDAMED
    FDA Adverse Event Death Summary report: N

    4-0 (BB) PROLENE SUTURE

    MDR report key: 24477700 · Received March 2, 2026

    Report

    Report Number
    MW5184508
    Event Type
    Death
    Date Received
    March 2, 2026
    Date of Event
    February 17, 2026
    Report Date
    February 24, 2026
    Manufacturer
    ETHICON (JOHNSON & JOHNSON)/ETHICON LLC
    Product Code
    GAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD HEART TRANSPLANT SURGERY (B)(6) 2026. JUST PRIOR TO TRANSFER OF PATIENT TO ICU, BLOOD PRESSURE DECREASED AND CHEST TUBES FILLED WITH BLOOD. THE CHEST WAS EMERGENTLY PREPPED AND DRAPPED AND REOPENED. THE AORTIC ANASTOMOSIS APPEARED TO HAVE DEHISCED. THERE WAS EVIDENCE THE 4-0 SUTURE BROKE. AN INTERRUPTED PROLENE SUTURE WAS PLACED TO ACHIEVE TEMPORARY HEMOSTASIS WHILE PATIENT WAS REHEPARINIZED FOR CARDIOPULMONARY BYPASS. THE PATIENT WAS RECANNULATED AND DIALYSIS INITIATED DUE TO SEVERE HYPERKALEMIA AND METABOLIC DERANGEMENT. ANTERIOR ASPECT OF THE AORTIC ANASTOMOSIS WAS REINFORCED. AFTER 45 MINUTES OF REPERFUSION, PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITH MODERATE PRESSOR SUPPORT AND INHALED NITRIC OXIDE. BIVENTRICULAR FUNCTION APPEARED REASONABLE. PATIENT KEPT IN OPERATING ROOM FOR A PERIOD OF OBSERVATION IN THE EVENT TRANSITION TO ECMO REQUIRED. PATIENT TRANSFERRED TO ICU. PATIENT DID NOT RECOVER AND PASSED (B)(6) 2026. AUTOPSY CONFIRMED FRAYED AND BROKEN 4-0 PROLENE SUTURE DIRECTLY CAUSE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540324 4-0 (BB) PROLENE SUTURE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON (JOHNSON & JOHNSON)/ETHICON LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death