BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1963286 · Received January 14, 2011

    Report

    Report Number
    2953200-2011-00103
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    July 16, 2009
    Report Date
    December 15, 2010
    Manufacturer
    MEDTORNIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT UNDERWENT THE INDEX PROCEDURE WITH PRE-TREATMENT BALLOON ANGIOPLASTY AND DELIVERY OF ONE ASSIGNED STENT IN THE PROXIMAL RCA AND ONCE ASSIGNED STENT IN THE MID RCA. THERE WERE NO CLINICAL SEQUELAE. THE ANGIOGRAPHIC CORE LAB REPORT IS NOT AVAILABLE. THE POST-PROCEDURE COURSE WAS UNCOMPLICATED AND THE PT WAS DISCHARGED ON ASA AND CLOPIDOGREL. THE PT REPORTED TO THE SITE THAT SHE HAD BEEN EXPERIENCING BLOOD IN HER STOOL WHICH BEGAN APPROXIMATELY ONE WEEK POST INDEX PROCEDURE. THE PT OBSERVED THAT SHE HAD APPROXIMATELY ONE TEASPOON OF BLOOD IN HER STOOL PER DAY BUT THAT THE BLEEDING HAS RESOLVED APPROXIMATELY 5 WEEKS LATER WITHOUT TREATMENT. THE SITE REPORTED THAT NO SOURCE DOCUMENTS ARE AVAILABLE AS THE PT CONTACTED HER PHYSICIAN'S OFFICE VIA TELEPHONE AND NO FURTHER EVALUATION OR TREATMENT WAS PERFORMED. (MFR 2953200-2011-00104).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR CLOPIDOGREL| ASPRIN