BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2172685 · Received July 20, 2011

    Report

    Report Number
    9612164-2011-00780
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 6, 2011
    Report Date
    February 28, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE PATIENT SUFFERED AN MI ON THE SAME DAY AS THE DEATH OCCURRED. IT IS UNKNOWN IF THE TARGET LESION WAS INVOLVED. REF MFR # 9612164-2011-00779, 9612164-2011-00780.

    Description of Event or Problem · 1

    AN ENDEAVOR RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL DURING INDEX PROCEDURE. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY FOLLOW UP. A PCI REVASCULARIZATION WAS CARRIED OUT APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE. AN ENDEAVOR RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE 2ND DIAGONAL BRANCH. PT'S CARDIAC STATUS WAS STABLE ANGINA AT 6 MONTH AND 1 YEAR FOLLOW UPS. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 1.5 YEAR FOLLOW UP. PT'S CARDIAC STATUS WAS STABLE ANGINA AT 2 YEAR FOLLOW UP. IT IS REPORTED THAT THE PT EXPIRED APPROXIMATELY 2.5 YEARS POST INDEX PROCEDURE. IT IS REPORTED AS A NON-SUDDEN CARDIAC DEATH. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO MI OR THE STUDY PROCEDURE. IT WAS NOT ASSESSABLE IF THE EVENT WAS RELATED TO THE STUDY STENT. IT WAS REPORTED THAT THERE WAS NO EVIDENCE OF STENT THROMBOSIS. AUTOPSY REPORT IS NO AVAILABLE. (REF MFR # 9612164-2011-00779).

    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 86 YR Death PATIENT WAS TAKING CLOPIDOGREL BUT NOT ASPIRIN| 24 HOURS PRIOR TO THE EVENT.