BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1992866 · Received February 4, 2011

    Report

    Report Number
    2953200-2011-00268
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 6, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: 98% STENOSIS. FAILURE TO DELIVER THE STENT & STENT DEFORMATION. FORCE WAS APPLIED TO THE DEVICE DURING THE PROCEDURE. EVAL, CONCLUSION: 98% STENOSIS. FORCE WAS APPLIED TO THE DEVICE DURING THE PROCEDURE. EVAL SUMMARY: THE STENT WAS POSITIONED BETWEEN THE INNER SHAFT MARKERS OF THE BALLOON ON THE RETURNED STENT DELIVERY SYSTEM. THE 14TH AND 15TH DISTAL SEGMENTS WERE RAISED AND DEFORMED.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO ADVANCE AN ENDEAVOR SPRINT 2.75MM DIAMETER X 30MM LENGTH RAPID EXCHANGE (RX) STENT IN A LESION IN THE DISTAL LAD WHICH EXHIBITED 98% STENOSIS. THE LESION HAD BEEN PRE-DILATED PRIOR TO THE ATTEMPTED ADVANCEMENT; HOWEVER, THE STENT COULDN'T PASS THROUGH THE LESION AND RESISTANCE WAS ENCOUNTERED. THE USE OF FORCE WAS APPLIED TO THE DEVICE DURING THE PROCEDURE. 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 0002019256

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR