BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA

    MDR report key: 1457209 · Received May 1, 2009

    Report

    Report Number
    2953200-2009-00544
    Event Type
    Malfunction
    Date Received
    May 1, 2009
    Date of Event
    September 9, 2009
    Report Date
    April 17, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). DISSECTION. LACK OF INFORMATION.

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION OF SFA ARTERY OR DISTAL VASCULATURE). (B)(4).

    Description of Event or Problem · 1

    A 6MM DIAMETER X 100 MM LENGTH COMPLETE SE STENT DELIVERY SYSTEM WAS SELECTED FOR INSERTION INTO A PT FOR THE TREATMENT OF AN UNK LESION. IT IS UNK IF THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THERE WAS A DISSECTION OF TARGET LESION 1 AND 2. NO OTHER INFO HAS BEEN OBTAINED. IT WAS REPORTED THAT THE PT RECOVERED WITHOUT TREATMENT. THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS RELATED TO THE STUDY STENT. THE INVESTIGATOR HAS INDICATED THAT THERE WAS A DEFINITE RELATION BETWEEN THE EVENT AND THE PROCEDURE. (MFR REPORT #2953200-2009-00543).

    Description of Event or Problem · 1

    PATIENT WAS 74 AT TIME OF INDEX PROCEDURE. ONE COMPLETE SE SFA PERIPHERAL STENT WAS SUCCESSFULLY DELIVERED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) AND ONE COMPLETE SE SFA PERIPHERAL STENT IN THE LEFT DISTAL SFA. APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE, OCCLUSION OF THE TARGET LESIONS WAS REPORTED. THE PATIENT UNDERWENT BALLOON ANGIOGRAPHY AND ATHERECTOMY. (REF MFR REPORT# 2953200-2009-00543, 2953200-2009-00544).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE SFA FGE MEDTRONIC CARDIOVASCULAR NA V00167565

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention