BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1062093 · Received June 18, 2008

    Report

    Report Number
    2953200-2008-00428
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 12 MM LENGTH MICRO DRIVER RX CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF A DISSECTION IN THE LAD. LESION MORPHOLOGY WAS NON-TORTUOUS WITH LITTLE CALCIFICATION AND 75% STENOSIS. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN INSERTED ANOTHER MANUFACTURER'S STENT AND SUCCESSFULLY DEPLOYED THE STENT AT THE LESION SITE. IVUS STUDY WAS PERFORMED AND A DISSECTION WAS NOTED. THE PHYSICIAN INSERTED THE MICRO DRIVER SDS TO TREAT THE DISSECTION; HOWEVER, THE STENT CAUGHT ON THE PROXIMAL EDGE OF THE DEPLOYED STENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT DELIVERY SYSTEM; UPON REMOVAL THE STENT DISLODGED. THE STENT WAS LOCATED IN THE LEFT CIRCUMFLEX AND WAS SNARED. NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT IS FINE. 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 MICRO DRIVER RX CORONARY STENT SYSTEM MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0000619601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention