BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3110633 · Received May 14, 2013

    Report

    Report Number
    9612164-2013-00526
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    November 25, 2012
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD AN ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED IN THE 1ST RPL. APPROXIMATELY 4 MONTHS POST THE INDEX PROCEDURE THE PATIENT HAD A NON-TARGET VESSEL REVASCULARIZATION DUE TO CORONARY ARTERY DISEASE OF THE LAD USING AN ENDEAVOR SPRINT STENT. IT WAS REPORTED THAT THE PATIENT SUFFERED A GI BLEED APPROXIMATELY 21 MONTHS POST INDEX WHICH REQUIRED A TRANSFUSION. IT WAS REPORTED THAT THIS EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT RECOVERED WITH TREATMENT. APPROXIMATELY 22 MONTHS POST INDEX PROCEDURE THE PATIENT HAD A GI BLEED. THE PATIENT WAS TREATED WITH A TRANSFUSION. PATIENT HAD ANOTHER GI BLEED EVENT APPROXIMATELY 23 MONTHS POST INDEX WHICH WAS TREATED WITH A TRANSFUSION AND MEDICATION. IT WAS REPORTED THAT THIS EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT RECOVERED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211840 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention CLOPIDOGREL, ASPIRIN