BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 3940616 · Received July 2, 2014

    Report

    Report Number
    9612501-2014-00210
    Event Type
    Death
    Date Received
    July 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GAW
    PMA / PMN Number
    K010909
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: THE CUSTOMER STATES: 7 PATIENTS HAVE DIED. AFTER REOPENING THE CHEST, THEY HAVE FOUND THAT THE AORTA TISSUE HAS BEEN TORN, BUT THE SUTURE STRING AND KNOT IS CORRECT. SURGEON COMMENTS (E.G. CONDITION OF TISSUE) - IT HAPPENED WITH SUTURES FROM NEW BOXES. SALES REP WAS PRESENT FOR THE CASE. [OTHER FTRS: (B)(4)]. ADD'L INFO RECEIVED: REPORTS HAVE BEEN COLLECTED FROM (B)(6) INVESTIGATORS THAT SHOW 4 PATIENTS OF 7 HAVE BEEN SPECIFIED AS HIGH RISK PATIENTS (NOT FIT FOR SURGERY). THE OTHER THREE PATIENTS HAVE BEEN OPERATED BY ONE SURGEON. SO THE INVESTIGATOR TEAM HAS ANNOUNCED THE CAUSE OF DEATH IS AWAY FROM THE SUTURES. WE DO NOT HAVE ACCESS TO THE PATIENTS DETAILS AS THEY ARE CONFIDENTIAL DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386142 SURGIPRO 6/0 30 BLUE CV-11 OPVN D/A SURGIPRO SUTURE GAW COVIDIEN D3B0533X

    Patients

    Seq Age Sex Outcome Treatment
    1 Death