BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1936108 · Received December 13, 2010

    Report

    Report Number
    2953200-2010-02547
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 18, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS/CONCLUSIONS: (FIBROTIC, STENOTIC LESION RESISTANT TO BALLOONING).

    Description of Event or Problem · 1

    A MICRO DRIVER RAPID EXCHANGE 2.75MM DIAMETER X 24MM LENGTH STENT WAS IMPLANTED IN A LESION SITUATED IN THE SVG TO RAMUS MARGINAL VESSEL AFTER THE LESION HAD BEEN PRE-DILATED. IT WAS NOTED AFTER POST DILATATION THAT A SEPARATION OF THE STENT OCCURRED. NO OTHER CLINICAL SEQUELAE WERE REPORTED. CINE IMAGE REVIEW: THE TARGET LESION IN THE SVG TO RAMUS MARGINAL APPEARS TO HAVE BEEN RESISTANT TO THE MULTIPLE BALLOON PRE-DILATATIONS COMPLETED PRIOR TO DEPLOYMENT OF THE MICRO-DRIVER STENT, SINCE THE CORONARY ANGIOGRAPHIC IMAGES APPEAR TO SHOW THAT THERE WAS LITTLE RESOLUTION OF THE STENOSIS PRIOR TO THE STENT DEPLOYMENT. IT APPEARS MOST LIKELY THAT THE PREVIOUSLY ADJACENT NON-WELDED STENT SEGMENTS OF THE MODULAR STENT, SEPARATED AS THEY CAME INTO CONTACT WITH THE MOST RESISTANT PART OF THE LESION. THIS SEPARATION BECAME MORE PRONOUNCED AFTER THE POST DILATATION ACTIVITIES AS THE RESISTANT LESION HAD MORE OF AN IMPACT ON THE STRUT SEPARATION AS FURTHER PRESSURE WAS PLACED ON THE STENT WITH THE POST-DILATATION BALLOON. A SECOND STENT WAS IMPLANTED TO COVER THE STENT STRUT SEPARATION OBSERVED IN THE MICRO DRIVER STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0001077362

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention