BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3933728 · Received July 15, 2014

    Report

    Report Number
    9612164-2014-00937
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    February 1, 2012
    Report Date
    August 5, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (DISSECTION). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DISSECTION). (B)(4).

    Additional Manufacturer Narrative · 1

    CEC HAS ADJUDICATED THE PATIENT DEATH AS CARDIAC.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE RAMUS. AN ANGIOGRAPHIC COMPLICATION OF DISSECTION OCCURRED DURING THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    THE PATIENT EXPIRED APPROXIMATELY 36 MONTHS POST INDEX PROCEDURE. THE CAUSE OF DEATH WAS VASCULAR LESION (VIRILIA). DEATH WAS ASSESSED AS NON-CARDIAC. IT IS REPORTED THAT THE PATIENT DIED BY THE RUPTURE OF THE MAIN LEG ARTERY. THE INVESTIGATOR HAS ASSESSED THE EVENT AS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412877 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0004647167

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization