BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 2150466 · Received June 7, 2011

    Report

    Report Number
    9612164-2011-00532
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: EIGHT STENT SEGMENTS WERE INTACT, THE REMAINING STENT SEGMENTS WERE STRETCHED, DAMAGED AND DEFORMED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (B)(4). (B)(4): EVAL RESULTS: (STENT NOT INSPECTED PRIOR TO USE). RESULTS AND CONCLUSION: HANDLING TECHNIQUE USED TO REMOVE THE PROTECTIVE SHEATH AND STYLETTE).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 3.0 MM DIAMETER X 38MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION IN A PT. IT WAS REPORTED THAT THE STENT DISLODGED UPON REMOVAL OF THE PROTECTIVE SHEATH AND THAT THE BALLOON ALONE WAS USED IN THE PT. INFO REC'D ALSO INDICATED THAT THE DEVICE WAS NOT PROPERLY INSPECTED PRIOR TO USE. NO PT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0004847022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK