BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2113819 · Received May 17, 2011

    Report

    Report Number
    9612164-2011-00425
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS: STENT DEFORMATION. NO CONCLUSION CAN BE DRAWN; LIMITED INFO AVAILABLE. EVAL, CONCLUSION: NO CONCLUSION CAN BE DRAWN; LIMITED INFO AVAILABLE. EVAL SUMMARY: A NUMBER OF STRUTS ON THE 10TH AND 11TH PROXIMAL STENT SEGMENTS WERE RAISED AND PULLED DISTALLY. A NUMBER OF SEGMENTS WERE PARTIALLY DEFORMED. THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 2.5 MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE LCX IN A PT. IT WAS REPORTED THAT THE STENT GOT CAUGHT DURING ADVANCEMENT INSIDE THE LCX, AND WHEN THE STENT WAS REMOVED FROM THE PT, THE STENT WAS NOTED TO BE DAMAGED. NO PT INJURY OCCURRED 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 0005038652

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK