BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA - IDE

    MDR report key: 3192640 · Received June 27, 2013

    Report

    Report Number
    2953200-2013-01208
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    April 25, 2013
    Report Date
    October 15, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    RESULTS, CONCLUSION: MYOCARDIAL INFARCTION. (B)(4).

    Description of Event or Problem · 1

    PATIENT DEATH WAS CAUSED BY AN MI. MI AND DEATH OCCURRED THE SAME DAY.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD TWO COMPLETE SE SFA STENTS IMPLANTED IN THE LEFT SFA. IT IS REPORTED THAT APPROXIMATELY 35 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. INVESTIGATOR HAS ASSESSED THAT THE EVENT IS NOT RELATED TO THE DEVICE. COMPLETE SE SFA IS UNDER INVESTIGATION PURSUANT TO AN IDE. THE DEVICE IS CURRENTLY APPROVED IN THE U.S. WITH AN ILIAC AND BILIARY INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294604 COMPLETE SE SFA - IDE STENT, ILIAC NIO MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Death