BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    MDR report key: 2041952 · Received March 30, 2011

    Report

    Report Number
    9612164-2011-00130
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: GI BLEED. CONCLUSION: BASED ON THE INFO PROVIDED NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT OTW DRUG ELUTING STENTS WERE IMPLANTED; ONE TO THE PROXIMAL RCA AND ONE TO THE DISTAL RCA. FIVE MONTHS POST INDEX PROCEDURE THE PT WAS ADMITTED TO (B)(6) WITH TARRY STOOLS AND ABDOMINAL PAIN. PT WAS REPORTED TO HAVE A GI BLEED AND ANEMIA. PT RECEIVED 2 UNITS OF PTBCS. AN ESOPHAGOGASTRODUODENOSCOPY FOUND AN ULCER IN THE ANTRUM OF THE STOMACH. PT RECOVERED WITH TREATMENT. INVESTIGATOR REPORTS THAT THE EVENT HAD NO RELATION TO THE DEVICE/PROCEDURE BUT A POSSIBLE RELATION TO THE DRUG. (MFR #9612164201100131).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R