BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 7027223 · Received November 14, 2017

    Report

    Report Number
    9612164-2017-01604
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    September 1, 2017
    Report Date
    November 14, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE REFERENCE: DOI.ORG/10.4070/KCJ.2017.0016. (B)(4). 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

    A 1,672 PATIENTS WERE RANDOMISED IN THE TRIAL AND 271 OF THESE HAD ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED. AT THE 1, 3, 6 AND 12 MONTHS FOLLOW UP, PATIENT DEATH WAS REPORTED ALONG WITH TARGET LESION RELATED MYOCARDIAL INFARCTION, REVASCULARIZATION OF TARGET LESION, STENT EDGE DISSECTION, OCCLUSION AND STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810378 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening