BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2093129 · Received April 14, 2011

    Report

    Report Number
    9612164-2011-00240
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (NO CONCLUSION CAN BE DRAWN BASED ON INFO AVAILABLE).

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENTS TO THE MID LEFT ANTERIOR DESCENDING, ONE IN THE LEFT AND ONE IN THE RIGHT. WHILE ATTEMPTING TO REMOVE THE BALLOON CATHETER FROM THE 3.0MM DIAMETER X 24MM LENGTH STENT, THE PHYSICIAN NOTICED STICKINESS. THE GUIDE CATHETER ALSO MOVED FORWARD A BIT. IT WAS REPORTED THAT THE BALLOON WAS FULLY DEFLATED AND THAT THE DEVICE WAS NOT RETRACTED AT AN ACUTE ANGLE RELATIVE TO THE TIP OF THE GUIDE CATHETER. THERE WAS NO ISSUE WITH THE PT WHO IS CURRENTLY REPORTED TO BE FINE AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005077536

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK