BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 183125 · Received August 19, 1998

    Report

    Report Number
    2953200-1998-00124
    Event Type
    Injury
    Date Received
    August 19, 1998
    Date of Event
    July 23, 1998
    Report Date
    July 24, 1998
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EXCESSIVELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION DUE TO CALCIFICATION OF THE TARGET LESION, THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY. THE "STENT WOULD NOT COME BACK INTO THE GUIDE CATHETER...STENT CAME BACK THROUGH GUIDE AT AN ANGLE AND CAUGHT THE PROXIMAL EDGE OF THE STENT ON TIP OF GUIDE AND FLARED OUT." UPON ATTEMPTED REMOVAL OF THE STENT FROM THE CORONARY AND INTO THE GUIDE CATHETER, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM IN THE LEFT MAIN CORONARY ARTERY AND CREATED AN OCCLUSION OF THAT ARTERY. A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY BALLOON WAS PLACED THROUGH THE STENT END INFLATED TO 1 ATM FOR RETRIEVAL OF THE STENT FROM THE CORONARY ARTERY. UPON ATTEMPTED REMOVAL, THE STENT DISLODGED FROM THE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY BALLOON AND MOVED INTO THE DESCENDING AORTA. THE STENT WAS THEN SNARED TO THE FEMORAL SHEATH RESULTING IN A DISSECTION AND OCCLUSION OF THE ILIAC/FEMORAL ARTERY. THE PT WENT TO SURGERY FOR BYPASS OF THE RIGHT FEMORAL ARTERY. THE PHYSICIAN DID NOT FOLLOW THE INSTRUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT. THE PT WILL RETURN TO THE HOSPITAL FOR TRIPLE CORONARY BYPASS SURGERY IN THE FUTURE. THE PHYSICIAN FEELS THE PT SHOULD HAVE HAD BYPASS SURGERY INITIALLY. THERE WAS NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.

    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 8F22E15

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention