BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1180460 · Received September 25, 2008

    Report

    Report Number
    2953200-2008-00867
    Event Type
    Injury
    Date Received
    September 25, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 28, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL CONCLUSIONS: PENDING ADDITIONAL INFO. UNKNOWN LOCATION OF STENT.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 8 MM LENGTH MICRO DRIVER RX CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN UNKNOWN LESION. LESION MORPHOLOGY WAS REPORTED AS SEVERE CALCIFICATION. IT IS UNKNOWN IF THE LESION WAS NOT PRE-DILATED. IT WAS REPORTED THAT THE UNDEPLOYED STENT DISLODGED IN THE ARTERY BEFORE BALLOON INFLATION. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THE PT'S CONDITION IS UNKNOWN. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0000762813

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention