BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 2180644 · Received May 5, 2011

    Report

    Report Number
    9612164-2011-00376
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL: RESULTS: (NO CONCLUSION CAN BE DRAWN BASED ON THE INFO PROVIDED, DEVICE/CINE IMAGES NOT AVAILABLE).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY A 2.75 MM DIAMETER X 12 MM LENGTH MICRO-DRIVER RAPID EXCHANGE STENT INTO A PT IN THE LEFT ANTERIOR DESCENDING ARTERY FOLLOWING PRE-DILATATION. ANGIOGRAM CONFIRMED THAT THE STENT WAS SUCCESSFULLY DEPLOYED. AN EMBOLIC PROTECTION DEVICE WAS ADVANCED TO THE TARGET LESION AND TWO OTHER STENTS WERE ALSO SUCCESSFULLY DEPLOYED. ONCE SUCCESSFUL DEPLOYMENT HAD BEEN VERIFIED FOR THESE TWO STENTS, THE PHYSICIAN REMOVED THE EMBOLIC PROTECTION DEVICE. THE ANGIOGRAM WAS REPEATED AND AT THIS POINT, THE PHYSICIAN NOTED THAT THE MICRO-DRIVER (RX) STENT APPEARED TO BE DAMAGED. IT IS REPORTED THAT THE STENT APPEARED TO BE STRETCHED/FRACTURED. THE PHYSICIAN THEN TRIED TO PASS A GUIDEWIRE AND A BALLOON THROUGH THE STENT, BUT EXPERIENCED RESISTANCE. HE CHANGED TO A DIFFERENT BALLOON AND THE STENT WAS SUCCESSFULLY POST-DILATED AND ANOTHER STENT WAS DEPLOYED WITHIN THE INITIAL STENT. THERE WAS NO HARM CAUSED TO THE PT DURING THE PROCEDURE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA 0005382630

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention