BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2831372 · Received November 14, 2012

    Report

    Report Number
    9612164-2012-01651
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    November 30, 2013
    Report Date
    July 10, 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: INHERENT RISK OF PROCEDURE (STROKE). CONCLUSIONS: INHERENT RISK OF PROCEDURE (STROKE). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT DEATH OCCURRED APPROXIMATELY 40 MONTHS POST INDEX PROCEDURE. CAUSE OF DEATH WAS NON- CARDIAC.

    Description of Event or Problem · 1

    PATIENT HAD THREE ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED DURING THE INDEX PROCEDURE. THE PREVIOUSLY REPORTED STROKE WAS TREATED WITH PTA OF THE RIGHT CAROTID ARTERY FOR STENOSIS.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD THREE ENDEAVOR RESOLUTE DRUG-ELUTING STENTS SUCCESSFULLY DEPLOYED; TWO AT LAD AND ONE AT LEFT MAIN. APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE, PATIENT UNDERWENT REVASCULARIZATION OF LEFT MAIN WITH THE DEPLOYMENT OF AN ENDEAVOR SPRINT DRUG-ELUTING STENT. APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE, PATIENT EXPERIENCED A STROKE WHICH WAS TREATED WITH MEDICATION. INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. PATIENT IS REPORTED TO BE IN REMISSION AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention CLOPIDOGREL AND ASPIRIN