BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3223299 · Received July 12, 2013

    Report

    Report Number
    9612164-2013-00708
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    October 14, 2010
    Report Date
    June 22, 2017
    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: MYOCARDIAL INFARCTION, DISSECTION, STENT THROMBOSIS. CONCLUSIONS: MYOCARDIAL INFARCTION, DISSECTION, STENT THROMBOSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INDEX DEVICE RELATIONSHIP TO THE TVR PREVIOUSLY REPORTED HAS BEEN UPDATED TO UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENT IMPLANTED IN THE RCA. THE FOLLOWING DAY THE PATIENT HAD A TARGET VESSEL REVASCULARIZATION OF THE RCA TO R-PDA USING FOUR NON-MEDTRONIC STENTS DUE TO ACUTE OCCLUSION CAUSED BY DISSECTION. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED. APPROXIMATELY 7.5 MONTHS POST INDEX PROCEDURE THE PATIENT HAD AN MI. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED. THE FOLLOWING DAY THE PATIENT HAD A STENT THROMBOSIS. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE THE PATIENT HAD A TARGET VESSEL REVASCULARIZATION OF THE RCA DUE TO STENOSIS USING FIVE NON-MEDTRONIC STENTS. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323818 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention