BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC AVE S540 OTW CORONARY STENT SYSTEM

    MDR report key: 235347 · Received August 13, 1999

    Report

    Report Number
    2953200-1999-00071
    Event Type
    Death
    Date Received
    August 13, 1999
    Date of Event
    July 7, 1999
    Report Date
    July 14, 1999
    Manufacturer
    MEDTRONIC AVE, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 2.5MM DIAMETER X 24MM LENGTH MEDTRONIC AVE S540 STENT WAS SUCCESSFULLY PLACED AT THE TARGET LESION IN THE CIRCUMFLEX CORONARY ARTERY AFTER PREDILATION WITH A 2.0MM DIAMETER PTCA BALLOON. AFTER PLACEMENT OF THE STENT, IT WAS NOTED THAT A SIDEBRANCH OFF OF THE CIRCUMFLEX HAD BEEN "JALLED" BY THE STENT AND PARTIALLY OCCLUDED. A PTCA BALLOON WAS PLACED THROUGH THE SIDE OF THE STENT AND INFLATED WITHIN THE SIDEBRANCH, RESULTING IN COMPLETE OCCLUSION OF THE SIDEBRANCH, A RISE IN CPK, S-T ELEVATION AND CHEST PAIN. IT IS THE OPINION OF THE PHYSICIAN THAT THE STENT CAUSED THE THROMBOSIS AND CLOSURE OF THE SIDEBRANCH, WHICH MAY BE RELATED TO THE DEATH OF THE PATIENT SIX DAYS LATER. HOWEVER, THE EXACT CAUSE OF THE PATIENT'S DEATH IS NOT KNOWN SINCE THE FAMILY REFUSED THE AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC AVE S540 OTW CORONARY STENT SYSTEM Implant OVER-THE-WIRE CORONARY STENT SYSTEM MAF MEDTRONIC AVE, INC. NA 9D12E05

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death PATIENT DURING THE STENT IMPLANT PROCEDURE:| (3000U), 5. NITROGLYCERIN AND 6. MORPHINE.| 1. VERSED, 2. FENTANYL, 3. LIDOCAINE, 4. HEPARIN| THE FOLLOWING MEDICATIONS WERE ADMINISTERED TO THE