BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2103640 · Received May 19, 2011

    Report

    Report Number
    9612164-2011-00449
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 30, 2008
    Report Date
    April 21, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: DISSECTION.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD A 4.0 MM DIAMETER X 24 MM LENGTH ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE DISTAL RCA, AS TREATMENT OF THE TARGET LESION. A SECOND ENDEAVOR RX STENT WAS IMPLANTED, ABUTTING THE PRIOR STENT, AS TREATMENT OF COMPLICATION/DISSECTION/BAILOUT. A SUSPECTED MI EVENT WAS ADJUDICATED BY THE CLINICAL EVENTS COMMITTEE TO HAVE OCCURRED ONE DAY POST INDEX PROCEDURE. THIS ADJUDICATION WAS BASED PURELY ON THE ACADEMIC RESEARCH CONSORTIUM (ARC) DEFINITION OF A MI ALONE. THERE IS NO EVIDENCE THAT THE PATIENT WAS SYMPTOMATIC OF AN MI AT THE TIME OF THE EVENT. MI WAS CATEGORIZED AS A NON Q WAVE MI, IN THE TERRITORY OF THE TARGET VESSEL. NO FURTHER DETAILS ARE AVAILABLE. PATIENT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY, 6 MONTH, 1 YEAR, 1.5 YEAR AND 2 YEAR FOLLOW-UP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention CLOPIDOGREL| ASPIRIN