BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 2822043 · Received November 7, 2012

    Report

    Report Number
    9612164-2012-01633
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 25, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ROOT CAUSE OF STENT DAMAGE WAS MOST LIKELY PROCEDURAL RELATED. STENT DAMAGE. CONCLUSIONS: ROOT CAUSE OF STENT DAMAGE WAS MOST LIKELY PROCEDURAL RELATED. STENT DAMAGE.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE A 2.5 X 18 MM ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO TREAT A LESION IN A PATIENT. IT WAS REPORTED THAT THE STENT WAS OBSERVED TO BE DAMAGED FOLLOWING REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION - THE STENT WAS DAMAGED AND THERE WAS EVIDENCE THAT THE DEVICE WAS USED IN THE PATIENT. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE DISTAL TIP WAS FLARED. THE BALLOON FOLDS ON THE PROXIMAL PILLOW WERE PARTIALLY OPENED AND DISTURBED. THE FIRST SIX PROXIMAL STENT SEGMENTS WERE INTACT. THE REMAINING SEGMENTS WERE DEFORMED AND SEVERELY STRETCHED WITH THE DISTAL SEGMENTS EXTENDING PAST THE DISTAL TIP. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE RX) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY RX).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006259346

    Patients

    Seq Age Sex Outcome Treatment
    1