BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO-DRIVER RX

    MDR report key: 1090923 · Received August 1, 2008

    Report

    Report Number
    2953200-2008-00631
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 3, 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

    MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS IS COMPLETE. THE STENT WAS NOT RETURNED. THE DISTAL TIP WAS SLIGHTLY STUBBED. THERE WAS CLEAR EVIDENCE OF CRIMP/BAKE IMPRESSIONS ON THE BALLOON WORKING LENGTH AND ON THE INNER MEMBER OF THE DEVICE INDICATING THAT THE STENT WAS ADHERED TO THE BALLOON. FROM THE INFO RECEIVED, IT APPEARS MOST LIKELY THAT THE STENT DISLODGED DUE TO THE DIFFICULT ANGLE OF THE BIFURCATION AND PRESENCE OF CALCIFIED PLAQUE.

    Description of Event or Problem · 1

    A 2.25 MM DIAMETER X 18 MM LENGTH MICRO-DRIVER RX CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN LAD AND LCX BIFURCATED LESION. LESION MORPHOLOGY WAS REPORTED TO BE A 90% STENOSIS LESION WITH 90 DEGREE TORTUOSITY. THE LESION WAS PRE-DILATED. PREDILATION REDUCED LESION STENOSIS TO 25%. IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE MICRO-DRIVER AND UPON ATTEMPTING TO REACH THE LESION, THE STENT BECAME CAUGHT IN THE BIFURCATION BETWEEN THE LAD AND LCX. UPON ATTEMPTED REMOVAL, THE STENT CAME OFF OF THE BALLOON. THE DISLODGED STENT WAS RETRIEVED WITH A SNARE. THE LAD APPEARED HAZY ON THE CINE IMAGING. THE PHYSICIAN DEPLOYED A 3.0 MM DIAMETER BY 18MM LENGTH DRIVER CORONARY STENT IN THE PROXIMAL LAD. AFTER STENT DEPLOYMENT, SLOW BLOOD FLOW WAS NOTICED AT THE LCX. THE PHYSICIAN THEN INSERTED A 2.25MM X 8MM AND MET WITH RESISTANCE 6MM DISTAL TO THE LCX. (REF. MDR #2953200-2008-00632).THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM AND THE STENT WAS NOT ON THE BALLOON. THE PHYSICIAN VISUALIZED THE STENT LOCATED IN THE PROXIMAL LCX. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE STENT WITH A SNARE BUT WAS UNSUCCESSFUL. THE STENT WAS BALLOONED; APPOSING THE STENT TO THE VESSEL WALL. THE BLOOD FLOW PROBLEM HAD RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS REPORTED TO BE FINE. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-DRIVER RX MAF MEDTRONIC CARDIOVASCULAR GALWAY NA 0000687193

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention