BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2090735 · Received April 14, 2011

    Report

    Report Number
    9612164-2011-00223
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    August 6, 2012
    Report Date
    October 2, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS - INHERENT RISK OF PROCEDURE (STROKE).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED IN THE MID LAD DURING INDEX PROCEDURE. PT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 30 DAY, 6 MONTH AND 2 YEAR F/US. IT IS REPORTED THAT THE PT SUFFERED AN ISCHEMIC STROKE APPROX 27.5 MONTHS POST INDEX PROCEDURE. THE PT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A TWO DAY HISTORY OF LEFT SIDED WEAKNESS AND DYSARTHRIA. CT SCAN OF THE HEAD AND CT ANGIO WERE NORMAL. IT IS REPORTED THAT THE PT WAS DIAGNOSED WITH A LACUNAR STROKE. STROKE DIAGNOSIS WAS CONFIRMED BY A NEUROLOGIST. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT. (REF MFR #9612164-2011-00222).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT SUFFERED A STROKE APPROXIMATELY 49 MONTHS POST INDEX PROCEDURE. INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND ENSP25024X 0000554615

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization CLOPIDOGREL 24 HOURS BEFORE THE EVENT.| PATIENT WAS TAKING ASPIRIN BUT NOT TAKING