BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2251334 · Received September 13, 2011

    Report

    Report Number
    9612164-2011-01133
    Event Type
    Death
    Date Received
    September 13, 2011
    Date of Event
    May 25, 2012
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS: CVA/STROKE. (ROOT CAUSE UNK). NO DEVICE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    TWO ENDEAVOR RX DRUG-ELUTING STENTS WERE SUCCESSFULLY IMPLANTED DURING INDEX PROCEDURE. ONE STENT (3.50 X 18MM) WAS IMPLANTED TO DISTAL RCA; ONE STENT (3.50 X 30MM) WAS IMPLANTED TO PROXIMAL RCA. PT WAS SYMPTOMATIC/FREE OF SYMPTOMS AT 30 DAY, 6, 9 AND 12 MONTH FOLLOW UP. A STROKE WAS REPORTED TO HAVE OCCURRED APPROXIMATELY TWO YEARS FOLLOWING INDEX PROCEDURE. PT RECEIVED MEDICAL TREATMENT. INVESTIGATOR WAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT OR STUDY PROCEDURES. PT IS IN REMISSION. (REF MFR# 9612164201101134).

    Description of Event or Problem · 1

    PATIENT EXPIRED DUE TO MULTI ORGAN FAILURE APPROXIMATELY 33 MONTHS POST THE INDEX PROCEDURE. THE INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENTS.

    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 78 YR Death| R CLOPIDOGREL| ASPIRIN