BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 4142489 · Received October 6, 2014

    Report

    Report Number
    9612164-2014-01270
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    January 8, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (HEMORRHAGE). EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (HEMORRHAGE).

    Description of Event or Problem · 1

    PREVIOUSLY REPORTED GI BLEED WAS ALSO TREATED WITH GASTRECTOMY AND PRBC TRANSFUSION.

    Description of Event or Problem · 1

    UPDATE TO PREVIOUSLY REPORTED GI BLEED EVENT - EVENT OCCURRED APPROXIMATELY 54 MONTHS POST INDEX PROCEDURE. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE LAD WAS TREATED WITH ONE ENDEAVOR SPRINT (RX) AND THE 1ST DIAGONAL WAS TREATED WITH ONE ENDEAVOR SPRINT (RX). THE PATIENT WAS PLACED INDEFINITELY ON ASPIRIN AND CLOPIDOGREL AND DISCHARGED FROM HOSPITAL. APPROXIMATELY 55 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED GI BLEED AND WAS DIAGNOSED WITH STOMACH CANCER AFTER ENDOSCOPY AND UNDERWENT A GASTROSTOMY. PATIENT'S ASPIRIN AND CLOPIDOGREL MEDICATION WAS STOPPED AND CURRENT OUTCOME IS UNRESOLVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623661 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Hospitalization CLOPIDOGREL & ASA