BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 2133401 · Received June 14, 2011

    Report

    Report Number
    9612164-2011-00576
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: (REACTION), (NO CONCLUSION CAN BE DRAWN BASED ON INFO PROVIDED).

    Description of Event or Problem · 1

    THE PT HAD TWO ENDEAVOR OVER THE WIRE (OTW) DRUG-ELUTING STENTS IMPLANTED. SINCE IMPLANT OF THE ENDEAVOR OTW STENTS THREE YEARS AGO, THE PT HAS EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH. THE PT HAS BEEN RE-HOSPITALIZED SEVERAL TIMES AND HAS HAD CARDIAC CATHETERIZATIONS PERFORMED, WHICH REVEALED THAT THE CORONARY ARTERIES ARE WORKING WELL. THE CAUSE OF CHEST PAIN AND SHORTNESS OF BREATH CANNOT BE ESTABLISHED. THE PT IS STILL HAVING PROBLEMS BREATHING. REFERENCE MFR REPORT NUMBER 9612164201100577.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW NIQ MEDTRONIC IRELAND NA 0000618951

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention