BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 375127 · Received February 5, 2002

    Report

    Report Number
    2210968-2002-00084
    Event Type
    Death
    Date Received
    February 5, 2002
    Date of Event
    July 15, 1999
    Report Date
    January 31, 2002
    Manufacturer
    ETHICON, INC. SAN LORENZO
    Product Code
    GAW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 1999 SUTURE WAS USED TO SECURE A DACRON PATCH TO THE INERNAL CAROTID ARTERY DURING A CAROTIO ENDARTERECTOMY. SIX DAYS LATER, THE PATIENT HEMORRHAGED WHEN THE SUTURE LINE AT THE PATCH "RUPTURED" AND SUBSEQUENTLY DIED 16 DAYS LATER. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF RUPTURED LEFT CAROTID ENDARTERECTOMY PATCH SUTURE LINE AND LEFT GROIN HEMATOMA. THE PT HAD DEVELOPED SUDDEN SWELLING ON THE PT'S LEFT NECK, PRE-ADMISSION, WITH RESPIRATORY DISTRESS. DURING EMERGENT SURGERY, THE SITE WAS DESCRIBED AS DISRUPTED LATERALLY, AND THERE WAS MASSIVE BLEEDING. THE PATCH AND SUTURES WERE REMOVED, AND THE SITE WAS REPAIRED WITH ANOTHER PATCH AND MORE 6-0 SUTURES, AND THE REMOVED PATCH WAS SENT TO PATHOLOGY. POST OPERATIVELY THE PATIENT WAS FOUND TO HAVE SYMPTOMS OF GLOBAL ISCHEMIA AND DEVELOPED SEVERE HYPOXIC ISCHEMIC ENCEPHALOPATHY WHICH WAS PROCEEDING INTO A VEGETATIVE STATE. CT SCAN SHOWED EXTENSIVE DAMAGE OF THE CORTEX. THE PATIENT EXPIRED IN 1999 AT 8:55 AM. CORONER'S REPORT INDICATES: CAUSE OF DEATH IS GLOBAL HYPOXIC ENCEPHALOPATHY FOLLOWING SPONTANEOUS RUPTURE OF LEFT CAROTID ENDARTERECTOMY FOR PLATELET THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. SAN LORENZO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death