BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2160560 · Received July 6, 2011

    Report

    Report Number
    9612164-2011-00677
    Event Type
    Death
    Date Received
    July 6, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (MI). CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE - (MYOCARDIAL INFARCTION). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE. THE PATIENT WAS FOUND DEAD AND THE SURROUNDING CIRCUMSTANCES ARE CURRENTLY UNAVAILABLE. INFORMATION RELATING TO THE PATIENT'S CAUSE OF DEATH IS NOT AVAILABLE. THE INVESTIGATOR CONFIRMED THAT AN AUTOPSY WAS NOT PERFORMED.

    Description of Event or Problem · 1

    DATE OF DEATH REPORTED AS 2011-(B)(6).

    Description of Event or Problem · 1

    APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED AN MI. INVESTIGATOR HAS NOT ASSESSED IF THE EVENT WAS RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT HAD ONE SUCCESSFUL DEPLOYMENT OF AN ENDEAVOR SPRINT STENT TO THE 4-R-PDA. RESIDUAL STENOSIS WAS ZERO PERCENT. SEVEN MONTHS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO AN INFECTION AND THE REASON FOR THE INFECTION WAS UNCLEAR. IN THE INVESTIGATORS OPINION, THE EVENT OF INFECTION WAS UNCLEAR REASON AND WAS CONSIDERED MODERATE IN INTENSITY, NOT RELATED TO THE STUDY MEDICATION, NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. UPDATED INFORMATION FOR THE INFECTION DETERMINATION: THE EVENT WAS UPDATED TO NSTEMI AND CARDIAC DECOMPENSATION (DECOMPENSATION CARDIAC, NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION.) FURTHER PNEUMONIA AND EXACERBATION OF THE KNOWN CHRONIC OBSTRUCTIVE PULMONARY DISEASE WAS ALSO DIAGNOSED. IN THE INVESTIGATORS OPINION, THE EVENT OF THE NSTEMI AND CARDIAC DECOMPENSATION WAS CONSIDERED MODERATE IN INTENSITY, NOT RELATED TO THE STUDY MEDICATION, STUDY DEVICE OR PROCEDURE. AS PER HCRI PHYSICIAN DETERMINATION OF THE EVENT OF THE NSTEMI AND CARDIAC DECOMPENSATION WAS CONSIDERED MODERATE IN INTENSITY, NOT RELATED TO THE STUDY MEDICATION, STUDY DEVICE OR PROCEDURE. THE PATIENT ALSO PRESENTED WITH DYSPNEA AND A FEELING OF CHEST PAIN BILATERALLY, THIS EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death