BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3951764 · Received July 23, 2014

    Report

    Report Number
    9612164-2014-00979
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    March 15, 2014
    Report Date
    June 24, 2014
    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

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). PATIENT CONDITION AFFECTED EFFECTIVENESS OF THE DEVICE (THE LESION HAD SEVERE TORTUOSITY, MODERATE CALCIFICATION AND 80% STENOSIS). DEFORMATION PROBLEM EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION DEVICE (THE LESION HAD SEVERE TORTUOSITY, MODERATE CALCIFICATION AND 80% STENOSIS). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO DEPLOY AN ENDEAVOR SPRINT DRUG ELUTING STENT. THE TARGET LESION WAS IN THE PROXIMAL CX. THE LESION HAD SEVERE TORTUOSITY, MODERATE CALCIFICATION AND 80% STENOSIS. THE LESION WAS PRE-DILATED WITH A 2.0X15MM BALLOON. THE PHYSICIAN REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND THE STENT COULD NOT CROSS THE LESION. WHEN THE STENT WAS WITHDRAWN IT WAS NOTICED THAT THE STENT WAS DEFORMED. THE PHYSICIAN BELIEVES THAT THE STENT DAMAGE WAS DUE TO THE USE OF THE DEVICE IN DIFFICULT LESION MORPHOLOGY. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. DEVICE EVALUATION: A NUMBER OF STRUTS ON THE 10TH PROXIMAL STENT SEGMENT WERE RAISED AND DEFORMED. THE REMAINING SEGMENTS WERE INTACT. THERE WAS NO DAMAGE EVIDENT TO THE DELIVERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430952 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006873137

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR