BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE

    MDR report key: 3328855 · Received September 6, 2013

    Report

    Report Number
    9612164-2013-00874
    Event Type
    Injury
    Date Received
    September 6, 2013
    Date of Event
    August 14, 2013
    Report Date
    July 4, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (ANEURYSM OR PSEUDOANEURYSM IN VESSEL OR AT VASCULAR ACCESS SITE). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (ANEURYSM OR PSEUDOANEURYSM IN VESSEL OR AT VASCULAR ACCESS SITE). (B)(4).

    Additional Manufacturer Narrative · 1

    IT IS REPORTED THE PATIENT HAS RECOVERED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, A COMPLETE SE STENT WAS USED TO TREAT A DISSECTION. IT IS REPORTED THAT THE PATIENT SUFFERED FROM AN ANEURYSM SPURIUM ON THE SAME DAY AS THE INDEX PROCEDURE. THE PATIENT UNDERWENT ANEURISM ELIMINATION SURGERY OF THE LEFT LIMB. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT WAS RELATED TO THE PROCEDURE. THE EVENT WAS RESOLVED. COMPLETE SE IS UNDER IDE INVESTIGATION FOR SFA INDICATION. FOR PURPOSES OF MDR, COMPLETE SE SFA IS CONSIDERED THE SAME AS COMPLETE SE ILIAC.

    Description of Event or Problem · 1

    STATUS OF THE ANEURYSM SPURIUM EVENT ON THE SAME DAY AS THE INDEX PROCEDURE IS CURRENTLY UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442969 COMPLETE SE STENT, ILIAC NIO MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention CLOPIDOGREL, ASPIRIN