BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 182061 · Received August 13, 1998

    Report

    Report Number
    2953200-1998-00116
    Event Type
    Death
    Date Received
    August 13, 1998
    Date of Event
    July 9, 1998
    Report Date
    July 14, 1998
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 24MM LENGTH AVE GFX STENT WAS INSERTED INTO AN 89 YEAR OLD PT WITH SEVERELY CALCIFIED CORONARY ARTERIES. THE TARGET LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS PREDILATED WITH 3.0MM DIAMETER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY BALLOON. AFTER DEPLOYMENT OF THE STENT, IT WAS NOTED THAT THERE WAS A PERFORATION OF THE TARGET VESSEL THAT RESULTED IN PT DEATH. THE REFERENCE VESSEL DIAMETER WAS LESS THEN 3.0MM (APPROXIMATELY 2.5MM) AND THE DOCTOR STENTED THAT HE DID NOT FEEL THE STENT WAS AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVE GFX OTW CORONARY STENT SYSTEM Implant OVER-THE-WIRE CORONARY STENT SYSTEM MAF ARTERIAL VASCULAR ENGINEERING, INC. NA 8D29E10

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death