BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE (5-0 PROLENE, C1, VB AND 6-0 PROLENE, BV1)

    MDR report key: 9632609 · Received January 27, 2020

    Report

    Report Number
    9632609
    Event Type
    Death
    Date Received
    January 27, 2020
    Date of Event
    October 28, 2019
    Report Date
    January 24, 2020
    Manufacturer
    ETHICON, LLC
    Product Code
    GAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT CAROTID ENDARTERECTOMY AT USER FACILITY. USER FACILITY LATER LEARNED THAT PATIENT EXPIRED AFTER DISCHARGE. MEDICAL EXAMINER REPORTED CAUSE OF DEATH DUE TO POSTSURGICAL SUTURE FAILURE FOLLOWING CAROTID ENDARTERECTOMY. NECK: THERE WAS A 15.0 X10.0 X8.0 AREA OF HEMATOMA AND SOFT TISSUE HEMORRHAGE IN THE RIGHT SIDE OF THE NECK. ON OPENING OF THE RIGHT COMMON CAROTID ARTERY DISTALLY TO THE BIFURCATION OF THE EXTERNAL CAROTID ARTERY AND CONTINUING DISTALLY INTO THE RIGHT INTERNAL CAROTID ARTERY, THERE WERE TWO SUTURE KNOTS AT EITHER END OF A CONTINUOUS RUNNING SUTURE LINE LOCATED ON THE EXTERNAL SURFACE OF THE PROXIMAL INTERNAL CAROTID ARTERY. BOTH KNOTS APPEARED INTACT. THE RIGHT COMMON AND INTERNAL CAROTID ARTERIES WERE OPENED OPPOSITE THE SUTURE LINE. INTERNALLY, THERE WAS A CONTINUOUS RUNNING SUTURE LINE ALONG A 4.0CM INCISION. AT THE PROXIMAL END OF THE INCISION, THERE WAS A FREE SUTURE END WHICH ALLOWED FOR A 1.3 CM LONG OPENING IN THE SUTURE LINE AT THE PROXIMAL END OF THE INCISION. OTHERWISE, EXAMINATION OF THE SOFT TISSUES OF THE NECK, INCLUDING STRAP MUSCLES, THYROID GLAND AND LEFT SIDED LARGE BLOOD VESSELS, BY LAYERED ANTERIOR NECK DISSECTION, REVEALED NO ABNORMALITIES. THE HYOID BONE AND LARYNX WERE INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94605 PROLENE (5-0 PROLENE, C1, VB AND 6-0 PROLENE, BV1) SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 20075 DA Death