BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3072232 · Received April 23, 2013

    Report

    Report Number
    9612164-2013-00455
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    January 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (CEREBROVASCULAR ACCIDENT). EVALUATION CONCLUSIONS: KNOWN INHERENT RISK OF PROCEDURE (CEREBROVASCULAR ACCIDENT).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENT IMPLANTED IN THE OBTUSE MARGINAL. APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED AN ISCHEMIC STROKE. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175624 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002947371

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization