BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3051985 · Received April 11, 2013

    Report

    Report Number
    9612164-2013-00401
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 3, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: HAEMORRHAGE. CONCLUSIONS: HAEMORRHAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT THROMBOSIS.

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED STENT THROMBOSIS WAS TREATED WITH UNKNOWN BRAND STENTS. IT IS REPORTED THAT THE PATIENT SUFFERED A GI BLEED APPROX 20 MONTHS POST INDEX PROCEDURE. PATIENT WAS GIVEN ORAL LIQUIDS AND IV FLUID, HYPERTENSION MEDICATION WAS STOPPED AND THE PATIENT HAD A COLONOSCOPY. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED.

    Description of Event or Problem · 1

    PATIENT HAD 2 ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED IN THE LAD DURING THE INDEX PROCEDURE. APPROXIMATELY 16 DAYS POST THE INDEX PROCEDURE SUSPECTED STENT THROMBOSIS OF THE STUDY STENT OCCURRED. A REVASCULARIZATION WAS CARRIED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156408 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005485481

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R ASA AND PRASUGREL