BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2166949 · Received July 13, 2011

    Report

    Report Number
    9612164-2011-00722
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 30, 2010
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: LESION MORPHOLOGY. NIDDM AND HP. MI, RESTENOSIS, STENT THROMBOSIS. EVALUATION: CONCLUSION: LESION MORPHOLOGY. PATIENT'S CONDITION PREDISPOSED EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN SUCCESSFULLY DEPLOYED A 3.5MM DIAMETER X 18MM LENGTH ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO THE PROXIMAL CIRCUMFLEX AND A 3.0MM DIAMETER X 24MM LENGTH ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO THE DISTAL CIRCUMFLEX RESULTING IN 0% STENOSIS. IVUS CONFIRMED COMPLETE APPOSITION OF BOTH STENTS TO THE VESSEL WALL. APPROXIMATELY ONE WEEK LATER, THE PATIENT PRESENTED AT THE HOSPITAL WITH CHEST PAIN. EMERGENCY CAG WAS PERFORMED. THIS CONFIRMED A STENT THROMBOSIS, PROXIMAL TO THE PREVIOUSLY DEPLOYED STENT TO THE DISTAL CIRCUMFLEX. AN MI WAS ALSO REPORTED TO HAVE OCCURRED. A TVR WAS PERFORMED RESULTING IN GOOD DILATATION AND BLOOD FLOW AND SUBSEQUENT RECOVERY OF THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. REFERENCE MFR REPORT NUMBER 2953200-2010-02193-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0001476376

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R PLETAL| ASPIRIN