BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 225859 · Received June 3, 1999

    Report

    Report Number
    2953200-1999-00048
    Event Type
    Injury
    Date Received
    June 3, 1999
    Date of Event
    April 26, 1999
    Report Date
    May 4, 1999
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUPPLEMENTAL INFO: A 4.0MM DIAMETER X 18MM LENGTH AVE GFX STENT WAS INSERTED INTO THE CIRCUMFLEX AFTER PREDILATION WITH A 3.5MM DIAMETER PTCA BALLOON AND AN UNSUCCESSFUL ATTEMPT TO CROSS THE LESION WITH ANOTHER MFR'S STENT. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION WITH THE AVE GFX STENT, THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY AND OUT OF THE PT. THREE DIFFERENT GUIDE CATHETERS WERE THEN INSERTED IN AN ATTEMPT TO ACHIEVE OPTIMAL GUIDE CATHETER SUPPORT IN THE LEFT MAIN ARTERY. AT THIS TIME, THE AVE GFX STENT WAS RE-INSERTED INTO THE CIRCUMFLEX BUT WAS NOT ABLE TO CROSS THE ACUTE BAND IN THE ARTERY, AND WHILE THE PHYSICIAN WAS MANIPULATING THE SYSTEM, THE ENTIRE SYSTEM PROLAPSED OUT OF THE ARTERY AND INTO THE AORTA. THE ENTIRE SYSTEM WAS REMOVED AS A UNIT TO THE FEMORAL SHEATH, WHERE THE STENT DELIVERY SYSTEM BALLOON, GUIDEWIRE AND GUIDE CATHETER WERE REMOVED, BUT THE STENT AND TIP OF THE GUIDEWIRE REMAINED WITHIN THE FEMORAL ARTERY. THE TIP OF THE GUIDEWIRE HAD BECOME ENTRAPPED IN THE "DEPRESSED" STENT. FLUOROSCOPIC VISUALIZATION REVEALED THAT THE STENT AND GUIDEWIRE MIGRATED DOWN THE ILIAC AND FEMORAL ARTERY AND INTO THE BIFURCATION OF THE COMMON FEMORAL ARTERY. THE TARGET LESION WAS THEN TREATED WITH A PERFUSION PTCA BALLOON WITH GOOD ANGIOGRAPHIC RESULTS. THERE WAS NO ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT, AND NO FURTHER INFO IS AVAILABLE FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant MAF ARTERIAL VASCULAR ENGINEERING, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention