BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 167411 · Received May 14, 1998

    Report

    Report Number
    2953200-1998-00071
    Event Type
    Death
    Date Received
    May 14, 1998
    Date of Event
    April 16, 1998
    Report Date
    April 17, 1998
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 30MM LENGTH AVE MICRO STENT II WAS INSERTED INTO A CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION; THEREFORE, THE STENT AND DELIVERY SYS WERE REMOVED FROM THE PT SUCCESSFULLY. SUBSEQUENTLY, TWO 3.0MM DIAMETER X 18MM LENGTH AVE GFX STENTS WERE PLACED TO TREAT THE DISTAL PORTION OF THE TARGET LESION AND A 3.5MM DIAMETER X 18MM LENGTH AVE GFX STENT WAS PLACED TO TREAT THE PROXIMAL PORTION OF THE TARGET LESION. THE DEPLOYED STENTS WERE POST DILATED WITH THE STENT DELIVERY SYSTEM BALLOON INFLATED TO 12 ATMOSPHERES OF PRESSURE. DURING POST DILATION OF THE MOST DISTAL STENT, THE BALLOON SLIPPED DISTAL TO THE END OF THE STENT AND CREATED A PERFORATION OF THE VESSEL. ALTHOUGH THERE WAS ALSO A QUESTIONABLE PERFORATION PROXIMAL TO THE PROXIMAL STENT, THE PT REMAINED STABLE AND THERE WAS NO FURTHER TREATMENT OF THE LARGER VESSEL. LATER THAT DAY, THE PT BECAME SYMPTOMATIC AND RETURNED TO THE THE LAB FOR A PERICARDIOCENTESIS. SUBSEQUENTLY, THE PT EXPIRED. THE PHYSICIAN DOES NOT ATTRIBUTE THE DEATH OF THE PT TO THE AVE STENTS. THERE IS NO FURTHER INFO AVAILABLE TO AVE REGARDING THIS CASE. MEDWATCH FORMS HAVE BEEN FILED SEPARATELY FOR EACH OF THE ABOVE DEVICES THAT WERE DEPLOYED IN THE TARGET LESION. THIS MEDWATCH REFERS TO THE MOST DISTALLY PLACED 3.0MM DIAMETER X 18MM LENGTH AVE GFX STENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| R