BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1595184 · Received February 3, 2010

    Report

    Report Number
    2953200-2010-00138
    Event Type
    Injury
    Date Received
    February 3, 2010
    Date of Event
    January 16, 2010
    Report Date
    January 19, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (INTERVENTION) (B) (4): EVALUATION RESULTS: (OCCLUSION OF SFA ARTERY OR DISTAL VASCULATURE).

    Description of Event or Problem · 1

    THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY AND HAD 100% STENOSIS. PRE-TREATMENT WAS PERFORMED WITH AN ABBOT BALLOON; DURING PRE-TREATMENT, A DISSECTION OCCURRED. ONE COMPLETE SE STUDY STENT WAS IMPLANTED. AN ADDITIONAL COMPLETE SE WAS DEPLOYED TO STABILIZE THE DISSECTION. BOTH STENTS WERE DEPLOYED SUCCESSFULLY. RESIDUAL STENOSIS 5%. APPROX 2.5 MONTHS POST INDEX PROCEDURE, OCCLUSION OF THE RIGHT SFA OCCURRED. THROMBOLYTIC THERAPY PROVIDED AND REVASCULARIZATION PERFORMED. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS PROBABLY RELATED TO THE STUDY DEVICE. THE PT RECOVERED WITH TREATMENT. COMPLETE SE IS NOT APPROVED FOR USE IN THE US FOR SFA INDICATION BUT IS SIMILAR TO COMPLETE SE WHICH IS APPROVED FOR BILIARY INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR NA V00164475

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death| R