BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO DRIVER RX CORONARY STENT SYSTEM

    MDR report key: 1023409 · Received April 2, 2008

    Report

    Report Number
    2953200-2008-00173
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 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

    EVALUATION: RESULTS - PT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (MODERATE TORTUOSITY WITH LITTLE CALCIFICATION AND 100% STENOSIS). INHERENT RISK OF PROCEDURE (STENT DISLODGEMENT). FAILURE TO FOLLOW INSTRUCTIONS (ADVANCEMENT THROUGH A PREVIOUSLY DEPLOYED STENT IS A WARNING IN THE IFU). CONCLUSIONS - DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT CONDITION (MODERATE TORTUOSITY WITH LITTLE CALCIFICATION AND 100% STENOSIS). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (ADVANCEMENT THROUGH A PREVIOUSLY DEPLOYED STENT IS A WARNING IN THE IFU).

    Description of Event or Problem · 1

    A 2.75MM DIAMETER X 18MM LENGTH MICRO DRIVER RX CORONARY STENT SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN LAD LESION. THE VESSEL MORPHOLOGY WAS REPORTED AS MODERATE TORTUOSITY WITH LITTLE CALCIFICATION AND 100% STENOSIS. THE LESION WAS NOT PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN HAD IMPLANTED ANOTHER MANUFACTURER'S DRUG-ELUTING STENT IN THE LMT, SOMETIME IN THE PAST. IT WAS REPORTED THAT THE PHYSICIAN INITIALLY IMPLANTED ANOTHER MANUFACTURER'S STENT AT A DISTAL LESION SITE IN THE LAD. IT WAS REPORTED THAT THE PHYSICIAN THEN ATTEMPTED THE MICRO DRIVER; HOWEVER HE FELT RESISTANCE WHILE PASSING THROUGH THE PREVIOUSLY DEPLOYED DRUG-ELUTING STENT. THE STENT DELIVERY BALLOON WAS INFLATED AND AT THAT TIME THE PHYSICIAN NOTICED THE STENT WAS NOT ON THE STENT DELIVERY SYSTEM. THE PHYSICIAN FOUND THE DISLODGED STENT NEAR THE NEEDLING POINT IN THE FEMORAL ARTERY; AND IT WAS REMOVED WITH A SNARE. THE LESION SITE WAS LEFT UNTREATED. THE DEVICE WAS DISCARDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT'S 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 0000403314

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention