BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 2344792 · Received November 22, 2011

    Report

    Report Number
    9612164-2011-01461
    Event Type
    Injury
    Date Received
    November 22, 2011
    Date of Event
    June 6, 2010
    Report Date
    September 11, 2010
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (STENT MIGRATION, OCCLUSION); CAUSED BY ANOTHER DRUG/DEVICE (MIGRATION WAS CAUSED BY THE PROCEDURAL GUIDEWIRE). EVALUATION, CONCLUSIONS: OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (MIGRATION WAS CAUSED BY THE PROCEDURAL GUIDEWIRE). (B)(4).

    Description of Event or Problem · 1

    A 3.0 MM X 12 MM ENDEAVOR RESOLUTE RAPID EXCHANGE DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL CX. THE TARGET VESSEL EXHIBITED A SIGNIFICANT BIFURCATE LESION INVOLVING THE OM1, WITH 90% STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE STENT WAS DIRECTLY IMPLANTED, WITH A GOOD RESULT REPORTED. RESISTANCE WAS ENCOUNTERED WHEN AN ATTEMPT WAS MADE TO REMOVE THE GUIDEWIRE. REO PRO WAS ADMINISTERED AND INTRACORONARY ASPIRATION WAS PERFORMED, HOWEVER NO CLOT WAS FOUND. IVUS WAS PERFORMED AND IT WAS OBSERVED THAT THE STENT WAS NOT IN PLACE IN THE LESION. ANOTHER DRUG-ELUTING STENT WAS THEN IMPLANTED IN THE PROXIMAL CX. IT IS REPORTED THAT THE OM1 SUBSEQUENTLY BECAME OCCLUDED. THE MIGRATED STENT WAS LOCATED IN THE PATIENT'S RIGHT LEG. THE RESULT OF THE PROCEDURE WAS REPORTED AS SUCCESSFUL. EVALUATION SUMMARY: PROCEDURAL IMAGES PROVIDED FOR REVIEW CONFIRMED THE SUCCESSFUL DEPLOYMENT OF THE 3.0 X 12 STENT BY DIRECT STENTING ACROSS THE TARGET LESION. THE DEPLOYMENT OF THE STENT APPEARS TO HAVE JAILED THE OM1 RESULTING IN TOTAL OCCLUSION OF THE SIDE BRANCH. SUBSEQUENT IMAGES CONFIRM THAT THE STENT IS NO LONGER ACROSS THE LESION AND THE OM1 IS NO LONGER OCCLUDED. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT - ENDEAVOR SPRINT RX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000851992

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention