BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 4222398 · Received November 4, 2014

    Report

    Report Number
    9612164-2014-01411
    Event Type
    Death
    Date Received
    November 4, 2014
    Date of Event
    March 16, 2014
    Report Date
    December 19, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEATH DEATH OCCURRED 53 MONTHS POST INDEX PROCEDURE AND NOT 55 MONTHS AS PREVIOUSLY REPORTED. CLINICAL EVALUATIONS COMMITTEE ADJUDICATED PATIENT DEATH AS NON-CARDIAC.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, ONE ENDEAVOR SPRINT DRUG ELUTING STENT WAS USED TO TREAT THE TARGET LESION IN THE LEFT CX. IT WAS REPORTED THAT 55 MONTHS POST INDEX PROCEDURE, THE PATIENT PASSED AWAY IN HOSPICE CARE AFTER SUFFERING CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). CAUSE OF DEATH LISTED AS COPD. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO STUDY DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708005 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death