BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3062513 · Received April 17, 2013

    Report

    Report Number
    9612164-2013-00430
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT DAMAGE, FAILURE TO DELIVER THE STENT). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TARGET LESION EXHIBITED APPROXIMATELY 95% STENOSIS). EVALUATION CONCLUSIONS: KNOWN INHERENT RISK OF PROCEDURE ((STENT DAMAGE, FAILURE TO DELIVER THE STENT). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TARGET LESION EXHIBITED APPROXIMATELY 95% STENOSIS).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT AN ENDEAVOR SPRINT DRUG-ELUTING STENT TO TREAT A LESION IN THE CX WITH APPROXIMATELY 95% STENOSIS. LESION PRE-DILATION WAS PERFORMED. DURING THE ATTEMPT TO DELIVER THE ENDEAVOR SPRINT STENT IT WAS REPORTED THAT THE STENT SLIPPED OVER THE DELIVERY SYSTEM. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 6TH DISTAL STENT SEGMENT WAS RAISED AND DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166388 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006212201

    Patients

    Seq Age Sex Outcome Treatment
    1