BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2103637 · Received May 19, 2011

    Report

    Report Number
    9612164-2011-00456
    Event Type
    Death
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 28, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ST, MI.

    Description of Event or Problem · 1

    PATIENT RECEIVED A 3.5MM DIAMETER X 12MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE PROX CX AND A 3.0MM DIAMETER X 12MM LENGTH ENDEAVOR SPRINT RX STENT IN THE RAMUS INTERMEDIUS DURING INDEX PROCEDURE. HOWEVER IT WAS REPORTED THAT DURING PROCEDURE, A THROMBUS WAS CONFIRMED WITHIN THE STENT DEPLOYED IN THE PROX CX. THROMBUS ASPIRATION WAS PERFORMED. PATIENT WAS TRANSFERRED TO ICU WERE THEY SUFFERED AN MI. PATIENT WAS RETURNED TO THE CATH LAB AND A NEW OCCLUSION WAS OBSERVED IN THE LAD THAT WAS TREATED WITH POBA. PROLONGED HOSPITALIZATION WAS REQUIRED. INVESTIGATOR REPORTED THAT THE VENT WAS DEFINITELY RELATED TO THE RELEVANT STENT AND POSSIBLY RELATED TO THE PROCEDURE. NO OTHER CLINICAL SEQUELAE WERE REPORTED. (REF MFR # 9612164201100457).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED. IT IS REPORTED THAT A PATIENT DEATH OCCURRED APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE. CAUSE OF DEATH ON DEATH CERTIFICATION: MYOCARDIAL INFARCTION. REF MFR # 9612164-2011-00457.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0002877104

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| D ASA| CA++ ANTAGONIST| CLOPIDOGREL| DIURETIC| LIPID LOWERING DRUG| LIPID LOWERING DRUG| CA++ ANTAGONIST| ASA| DIURETIC| CLOPIDOGREL