BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 4122061 · Received September 26, 2014

    Report

    Report Number
    2210968-2014-11676
    Event Type
    Death
    Date Received
    September 26, 2014
    Date of Event
    July 29, 2014
    Report Date
    August 1, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG) AND AORTIC VALVE REPLACEMENT (AVR) PROCEDURES ON (B)(6) 2014 AND SUTURE WAS USED. THE CORONARY ARTERIES INVOLVED IN THE PROCEDURE WERE LAD, D1 AND OM1. THE PATIENT ALSO HAD MULTIPLE GRAFTS AND A MITRAL VALVE REPAIR. AFTER COMPLETING THE LEFT ATRIAL CLOSURE, THERE WAS A LEAK NOTED. THE SURGEON NOTED THE SUTURE WAS BROKE. ANOTHER LIKE DEVICE AND THE SURGERY WAS COMPLETED AFTER DETECTION OF THE LEAK. THE FOLLOWING DAY, (B)(6) 2014, THE PATIENT EXPIRED. IT WAS REPORTED THAT THE PATIENT DIED FROM AN AIR EMBOLISM TO THE BRAIN. THE SURGEON OPINES THAT THE LEFT ATRIAL LEAK LEAD TO AIR IN THE BRAIN. HOWEVER, THERE WERE MULTIPLE GRAFTS AND A MITRAL VALVE REPAIR WHICH LEAD TO MITRAL VALVE REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600347 PROLENE POLYPROPYLENE SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. UNK GGE599

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| R