BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGIPRO 6/0 30 BLUE CV-11 D/A

    MDR report key: 2953843 · Received February 6, 2013

    Report

    Report Number
    9612501-2013-00010
    Event Type
    Death
    Date Received
    February 6, 2013
    Report Date
    January 14, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GAW
    PMA / PMN Number
    K010909
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: CAROTID ENDARTERECTOMY FOR ARTERIOSCLEROSIS. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT THE SUTURE BROKE ON A CAROTID. THE PT HAD TO BE SENT BACK TO SURGERY IN EMERGENCY. IT WAS REPORTED THAT THE PT LOST MORE THAN 500CC OF BLOOD, EXPERIENCED TISSUE LOSS, AND UNDERWENT A BLOOD TRANSFUSION. THE SURGEON REPORTS THAT THE PT DEVELOPED SWELLING IN HIS NECK FOLLOWING CAROTID ENDARTERECTOMY FOR NON-MAJOR ARTERIOSCLEROSIS. HE BECAME HYPOTENSIVE, AND REQUIRED REINTUBATION THAT WAS DIFFICULT. HE WAS TAKEN TO SURGERY AND IT WAS FOUND THAT THE SURGIPRO BROKE 1/2 WAY DOWN THE SUTURE LINE. THE PT LOST 2-3 LITERS OF BLOOD. THE PT'S TISSUE WAS REPORTED TO BE INTACT AND WAS HEALTHY. THE SURGEON DID NOT SAVE THE SUTURE USED IN THE CASE AND STATES THAT THE PT DIED FOUR DAYS LATER OF BRAIN DEATH FROM CEREBRAL ISCHEMIA. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49540 SURGIPRO 6/0 30 BLUE CV-11 D/A SURGIPROII SUTURE GAW COVIDIEN D2D1001X

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death