BEUDAMED
    FDA Adverse Event Death Summary report: N

    133650 PREMIUM SURGICLIP III 9.0

    MDR report key: 6078793 · Received November 4, 2016

    Report

    Report Number
    2647580-2016-00916
    Event Type
    Death
    Date Received
    November 4, 2016
    Date of Event
    August 4, 2016
    Report Date
    October 17, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    FZP
    PMA / PMN Number
    K142869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION INVOLVING A PREMIUM SURGICLIP III 9.0 SUBJECT TO PATIENT EVENT REPORTS CAPTURED UNDER THE FOLLOWING FILES: (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS EVALUATION WAS BASED ON A MEDICAL REVIEW OF ALL THE DATA RECEIVED FROM THE SITE AND A PMV REVIEW OF COMPLAINT TRENDS. THE CLINICALLY APPLIED PRODUCT WAS NOT AVAILABLE FOR ANALYSIS AND WAS THE SUBJECT OF ONE PATIENT EVENT. PHOTOGRAPHS WERE NOT RECEIVED FOR ANALYSIS. THIS INCIDENT WAS CHARACTERIZED BY POSTOPERATIVE BLEEDING. THE PATIENT HAD BLEED AT 10 PM FRIDAY FROM A HEMATOMA FROM THE RIGHT STRAP MUSCLE REGION. THE PATIENT SUFFERED A HEART ATTACK AND IRREVERSIBLE HYPOXIC BRAIN INJURY AND DIED. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT A BILATERAL NECK DISSECTION, RESECTION OF A TONGUE TUMOR AND RECONSTRUCTION. THE PATIENT EXPERIENCED A POST-OPERATIVE BLEED 30 HOURS FOLLOWING THE PROCEDURE. SHE WAS BROUGHT BACK TO THE OPERATING ROOM WHERE THE SURGEON EVACUATED A HEMATOMA FROM THE RIGHT STRAP MUSCLE REGION. THE PATIENT SUFFERED A CARDIAC ARREST AND IRREVERSIBLE HYPOXIC BRAIN INJURY, SUBSEQUENTLY PASSING AWAY ON (B)(6) 2016. DURING THE ORIGINAL PROCEDURE, THE BLOOD PRESSURE HAD BEEN RAISED ALONG WITH A VALSVA PROCEDURE TO TEST FOR BLEEDING AND ANASTOMOTIC LEAKS. IT IS UNKNOWN IF A CLIP HAD DISLODGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729314 133650 PREMIUM SURGICLIP III 9.0 CLIP, IMPLANTABLE FZP COVIDIEN, FORMERLY USSC PUERTO RICO INC 133650

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death