BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1963257 · Received January 13, 2011

    Report

    Report Number
    2953200-2011-00099
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 5, 2010
    Report Date
    December 17, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (GI BLEED).

    Description of Event or Problem · 1

    ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED AT THE RIGHT POSTERIOR DESCENDING ARTERY AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED AT THE 1ST OBTUSE MARGINAL (REF MFR REPORT# 2953200-2011-00100). A SPONTANEOUS GI BLEED IS REPORTED TO HAVE OCCURRED APPROX 3 MONTHS POST INDEX PROCEDURE. INVESTIGATOR ASSESSED THAT THERE WAS NO RELATIONSHIP TO THE STUDY DEVICE. IT IS REPORTED THAT THE GI BLEED RESULTED IN A PRBC AND PLATELET TRANSFUSION AND DISCONTINUATION OF STUDY DRUGS (ASPIRIN AND CLOPIDOGREL). PT WAS TAKING ASPIRIN AND CLOPIDOGREL AT THE TIME OF EVENT. IT IS REPORTED THAT THE PT RECOVERED WITH TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention PT WAS TAKING ASPIRIN| & CLOPIDORGREL AT THE TIME OF EVENT.