BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1012333 · Received February 12, 2008

    Report

    Report Number
    2953200-2008-00124
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 15, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE STENT WAS NOT RETURNED. THE DELIVERY SYSTEM REVEALED THAT THE HYPOTUBE WAS BENT AND SIGHTLY KINKED, 42CM DISTAL TO THE STRAIN RELIEF. THE BALLOON PILLOWS WERE INTACT, AND STENT BAKE CRIMP IMPRESSIONS WERE EVIDENT ON THE BALLOON. THE DISTAL TIP WAS SLIGHTLY DAMAGED. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 12 MM LENGTH MICRO DRIVER RX CORONARY STENT SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF A MID CIRCUMFLEX LESION. THE VESSEL MORPHOLOGY WAS REPORTED AS MODERATE TORTUOSITY WITH SEVERE CALCIFICATION AND 90% STENOSIS. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE MICRO DRIVER DELIVERY SYSTEM AND WHILE ADVANCING, THE STENT GOT STUCK IN THE FIRST BEND AND WAS UNABLE TO REACH THE TARGET LESION. THE PHYSICIAN PULLED THE DELIVERY SYSTEM BACK AND THE STENT DISLODGED IN THE LEFT MAIN, HOWEVER, REMAINED ON THE WIRE. THE PHYSICIAN USED MULTIPLE WIRES AND BALLOONS TO SUCCESSFULLY BRING THE DISLODGED STENT BACK INTO THE GUIDE CATHETER. THE ENTIRE SYSTEM WAS REMOVED AND THE PHYSICIAN STARTED THE ENTIRE PROCEDURE OVER. THE CASE WAS COMPLETED WITH A DRIVER STENT SUCCESSFULLY DEPLOYED IN THE CIRCUMFLEX. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0000624292

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention