BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 2833431 · Received November 15, 2012

    Report

    Report Number
    9612164-2012-01657
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    August 26, 2011
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (HAEMORRHAGE).

    Additional Manufacturer Narrative · 1

    PATIENT HAS A HISTORY OF DIABETES, PRIOR MI AND PRIOR PVD. INDEX PROCEDURE WAS PROMPTED BY SILENT ISCHEMIA. THE EVENT DATE OF THE PREVIOUSLY REPORTED BLEED IS UNK. INVESTIGATOR HAS INDICATED THAT THE EVENT IS NOT RELATED TO THE STUDY DEVICE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD TWO ENDEAVOR STENTS IMPLANTED. APPROXIMATELY 23.5 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED A GI BLEED FROM THE STOMACH AND DUODENUM. MEDICINE WAS PRESCRIBED. IT WAS NOT ASSESSED IF EVENT WAS RELATED TO DEVICE. IT WAS REPORTED THE PATIENT RECOVERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R