BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2190795 · Received July 15, 2011

    Report

    Report Number
    9612164-2011-00732
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 3, 2011
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - (CVA/STROKE), CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ON THE DAY OF THE INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED IN PROXIMAL RCA. APPROXIMATELY ONE YEAR POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH SYMPTOMS OF VERTIGO, DIZZINESS AND A HEADACHE. AN MRI FOUND NEUROLOGICAL INTERCEREBRAL BLEEDING - AMYLOID ANGIOPATHY VS CAVERNOUS HEMANGIOMAS. ASPIRIN AND CLOPIDOGREL WAS STOPPED AND TREATMENT WAS GIVEN IN THE FORM OF MEDICATION. TREATMENT IS ONGOING. THIS EVENT WAS DEEMED TO HAVE A POSSIBLE RELATIONSHIP WITH THE STUDY DRUG.

    Description of Event or Problem · 1

    CEC ADJUDICATED THE PREVIOUSLY REPORTED STROKE OCCURRED APPROXIMATELY 3 DAYS EARLIER THAN PREVIOUSLY REPORTED. PATIENT WAS DISCHARGED FROM HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization ASPIRIN| CLOPIDOGREL