BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4173234 · Received October 15, 2014

    Report

    Report Number
    9612164-2014-01329
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    February 26, 2014
    Report Date
    September 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT DEFORMATION). DEFORMATION PROBLEM (STENT). RELATED TO OPERATIONAL CONTEXT (NO DAMAGE ON THE DEVICE THAT COULD IMPACT STENT SIZE. ISSUE APPEARS TO BE PROCEDURAL RELATED). EVALUATION CONCLUSIONS: KNOWN INHERENT RISK OF PROCEDURE (STENT DEFORMATION). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (NO DAMAGE ON THE DEVICE THAT COULD IMPACT STENT SIZE. ISSUE APPEARS TO BE PROCEDURAL RELATED). (B)(4).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO TREAT AN LCA LESION USING AN ENDEAVOR RESOLUTE DRUG ELUTING STENT. IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE DEVICE TO THE TARGET LESION, THEN NOTED THE DEVICE WAS NOT LONG ENOUGH TO REACH THE LESION. THE DEVICE WAS REMOVED AND ANOTHER UNKNOWN DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT PHYSICIAN USED THE IPSILATERAL APPROACH. NO REPORTED PATIENT COMPLICATIONS. THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY AND THROUGH ANALYSIS OF THE RETURNED DEVICE THE STENT WAS OBSERVED TO BE DAMAGED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 3RD DISTAL STENT SEGMENT WAS RAISED AND DEFORMED. THE NUMBER OF STENT SEGMENTS AND LENGTH OF STENT WERE MEASURED AND FOUND TO BE WITHIN THE MANUFACTURING SPECIFICATION. PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655590 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006135610

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR