BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2003684 · Received February 24, 2011

    Report

    Report Number
    2953200-2011-00497
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (DISLODGED AND DISSECTION), (CAUGHT ON PREVIOUSLY DEPLOYED NON-MEDTRONIC STENT). CONCLUSIONS: (CAUGHT ON PREVIOUSLY DEPLOYED NON-MEDTRONIC STENT).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO DELIVER AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING CORONARY STENT (DETAILS UNK) INTO A PT'S MID/DISTAL RIGHT CORONARY ARTERY, THROUGH A PREVIOUSLY DEPLOYED NON-MEDTRONIC STENT. THE TARGET VESSEL EXHIBITED MODERATE TORTUOSITY AND CALCIFICATION. THE ENDEAVOR SPRINT STENT GOT CAUGHT ON THE STRUTS OF THE PREVIOUSLY DEPLOYED STENT AND GOT STRIPPED OFF THE BALLOON. THE STENT HAD TO BE REMOVED BY GOOSE-NECK SNARE. AFTER IT HAD BEEN SUCCESSFULLY REMOVED, A DISSECTION WAS NOTED IN THE AREA. BOTH THIS DISSECTION AND THE ORIGINAL INTENDED LESION WERE TREATED WITH OTHER STENTS. (DETAILS UNK). THE PT IS REPORTED TO BE FINE AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention