BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1876006 · Received October 15, 2010

    Report

    Report Number
    2953200-2010-01983
    Event Type
    Death
    Date Received
    October 15, 2010
    Date of Event
    April 18, 2010
    Report Date
    May 2, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: CVA/STROKE.

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED ABUTTING IN THE MID LAD, ONE IN A SIDE BRANCH AND ONE IN THE PARENT VESSEL. AT 1 MONTH, 6 MONTH AND 12 MONTH FOLLOW UP'S PT WAS ASYMPTOMATIC/FREE OF SYMPTOMS. IT IS REPORTED THAT THE PT SUFFERED AN ISCHEMIC STROKE APPROX 13 MONTHS POST INDEX PROCEDURE. THE PT WAS ADMITTED WITH DIAGNOSIS OF GAIT INSTABILITY/POSSIBLE STROKE. DISCHARGE DIAGNOSIS WAS WEAKNESS PROBABLY DUE TO A SMALL LACUNAR STROKE. IT IS REPORTED THAT THE PT RECOVERED WITH TREATMENT. DIAGNOSIS WAS BASED ON A RADIOLOGICAL EVALUATION AND WAS CONFIRMED BY A NEUROLOGIST. INVESTIGATOR INDICATED THAT THERE WAS NO RELATIONSHIP TO THE STUDY DEVICE. REFERENCE MFR # 2953200-2010-01982.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Death| H UNK.