BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 2960216 · Received February 14, 2013

    Report

    Report Number
    9612164-2013-00167
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 23, 2011
    Report Date
    May 27, 2015
    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

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

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR RAPID EXCHANGE RX DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED TO THE RIGHT POSTERIOR DESCENDING. APPROXIMATELY 14 MONTHS 3 WEEKS POST INDEX PROCEDURE THE PATIENT UNDERWENT REVASCULARIZATION OF RIGHT POSTERIOR DESCENDING AND LATERAL. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE . THE PATIENT SUFFERED A GI BLEED. THE BLEED WAS TREATED BY ABLATION USING ENDOSCOPE. THE PATIENT IS REPORTED TO BE IN REMISSION. INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ADVISED THAT INVESTIGATOR HAS INDICATED THAT THE PREVIOUSLY REPORTED GI BLEED WAS NOT RELATED TO THE STUDY DEVICE. THE EVENT WAS ATTRIBUTED TO A GASTRIC ULCER DUE TO A HELICOBACTER PYLORI INFECTION. TREATMENT WAS THE DISCONTINUATION OF ASPIRIN AND TICLOPIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64144 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention ASPIRIN, TICLOPIDINE