BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1120005 · Received August 14, 2008

    Report

    Report Number
    2953200-2008-00680
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    A 3.0 MM DIAMETER X 9 MM LENGTH DRIVER RX CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF A CTO OF THE CIRCUMFLEX ARTERY. LESION MORPHOLOGY WAS NOT REPORTED. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE DRIVER STENT AND WAS ATTEMPTING TO REACH THE LESION SITE; HOWEVER, IT WAS UNABLE TO CROSS THE LESION. UPON REMOVAL OF THE DELIVERY SYSTEM, THE STENT DISLODGED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DISLODGED STENT WITH WIRES THAT WERE IN PLACE. THE STENT WAS LOCATED IN THE PROXIMAL LAD. A SECOND STENT WAS USED TO SECURE THE DRIVER IN A NON-DISEASED PORTION OF THE VESSEL. THE PATIENT IS REPORTED TO BE SATISFACTORY. MEDTRONICS HAS RECEIVED TWO ANGIOGRAPHIC IMAGES AND THE REVIEW HAS BEEN COMPLETED. THE IMAGES SHOWED THE DISLODGED STENT IN THE LAD. THE STENT APPEARED TO BE DEFORMED ON THE DISTAL END WITH SOME DAMAGE NOTED IN THE MID SECTION OF THE STENT. IT IS POSSIBLE THAT THE STENT WAS DAMAGED DURING THE ATTEMPTED PLACEMENT; HOWEVER, THIS CANNOT BE CONFIRMED. IT APPEARS MOST LIKELY THAT ATTEMPTED PLACEMENT AND RETRACTION OF THE STENT IN THE OCCLUDED LESION IMPACTED ON THE STENT RETENTION OF THE DEVICE RESULTING IN THE REPORTED STENT DISLODGEMENT. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0000566847

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK