BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2160591 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00680
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 10, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (GI BLEED). CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE PATIENT HAD 3 ENDEAVOR SPRINT RX STENTS IMPLANTED ON THE DAY OF THE INDEX PROCEDURE: ONE IN THE PROXIMAL LCX, ONE IN THE FIRST LEFT POSTEROLATERAL BRANCH AND ONE IN THE MID LAD. THE PATIENT ALSO UNDERWENT A STAGED PROCEDURE APPROXIMATELY 3 WEEKS FROM INDEX PROCEDURE AND HAD ANOTHER ENDEAVOR SPRINT RX IMPLANTED IN THE MID RCA. APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT SUFFERED FROM A GI BLEED THAT WAS IDENTIFIED DUE TO DARK STOOL. PATIENT DID NOT HAVE ABDOMINAL PAIN AND WAS ADMITTED FOR IV HYDRATION, IV PROTONIX AND UNDERWENT A BLOOD TRANSFUSION. EDG/COLON REVEALED GASTRITIS AND NO ACTIVE BLEED. THE PATIENT WAS DISCHARGED AND RECOVERED WITH TREATMENT. REFERENCE MFR REPORT NUMBERS 9612164-2011-00679, 00681 AND 00682.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ASPIRIN| CLOPIDOGREL