BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1011308 · Received March 11, 2008

    Report

    Report Number
    2953200-2008-00112
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 10, 2008
    Report Date
    February 11, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: LACK OF INFO, PENDING DEVICE EVALUATION.

    Description of Event or Problem · 1

    A 3.0 MM DIAMETER X 30 MM LENGTH ENDEAVOR RX STENT DELIVERY SYSTEM WAS INSERTED IN A PT FOR TREATMENT OF A PROXIMAL/OSTIAL LAD LESION. VESSEL MORPHOLOGY WAS REPORTED TO BE MODERATELY TORTUOUS WITH MODERATE CALCIFICATION AND A 95 % STENOSIS. THE LESION WAS NOT PREDILATED. IT WAS REPORTED THAT THE STENT WAS SUCCESSFULLY DEPLOYED; UPON ATTEMPTED DEFLATION OF THE STENT DELIVERY BALLOON AND IT WAS UNABLE TO DEFLATE. THE PHYSICIAN OVERINFLATED THE BALLOON AND DEFLATED THE BALLOON AGAIN AFTER APPROX ONE MIN DEFLATION. DURING WITHDRAWAL OF THE DELIVERY SYSTEM, THE PHYSICIAN NOTICED A DISSECTION FROM THE LAD TO LMA REACHING THE RCX. THE DISSECTION WAS TREATED WITH DEPLOYMENT OF A MICRO DRIVER IN THE RCX AND A DRIVER CORONARY STENT IN THE LMA. THE PT WAS THEN TRANSFERRED TO EMERGENCY CABG. THE PT'S POST CABG PROCEDURE STATUS IS UNK. 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 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000566135

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK