BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 4299354 · Received December 5, 2014

    Report

    Report Number
    9612164-2014-01599
    Event Type
    Injury
    Date Received
    December 5, 2014
    Date of Event
    December 1, 2014
    Report Date
    December 8, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS - INHERENT RISK OF PROCEDURE (OCCLUSION/RESTENOSIS).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE A REVASCULARIZATION OF THE RIGHT SFA WAS PERFORMED TO TREAT THE PREVIOUSLY REPORTED RIGHT SFA RE-OCCLUSION EVENT APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE. 2 NON MEDTRONIC BALLOONS, 2 PACIFIC PLUS BALLOONS, ONE IN.PACT PACIFIC BALLOON AND A NON MEDTRONIC STENT WERE USED AS TREATMENT.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE A COMPLETE SE PERIPHERAL STENT WAS USED TO TREAT A LESION LOCATED IN THE SFA OF THE RIGHT LEG. APPROXIMATELY 12 MONTHS LATER IT IS REPORTED THAT THE PATIENT SUFFERED FROM RESTENOSIS OF THE R.SFA. INVESTIGATOR INDICATED THE EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE. EVENT IS CONTINUING. APPROXIMATELY 18 MONTHS POST THE INDEX PROCEDURE IT IS REPORTED THAT THE PATIENT SUFFERED FROM RE-OCCLUSION OF THE R.SFA. EVENT IS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788311 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| R