BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE SFA

    MDR report key: 3674555 · Received March 12, 2014

    Report

    Report Number
    2953200-2014-00459
    Event Type
    Injury
    Date Received
    March 12, 2014
    Date of Event
    May 7, 2014
    Report Date
    February 6, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    NIP
    PMA / PMN Number
    P110040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS, CONCLUSION: AMPUTATION.

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE ¿ (OCCLUSION). CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (OCCLUSION). (B)(4).

    Description of Event or Problem · 1

    THE AMPUTATION EVENTS ARE REPORTED AS RESOLVED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PHYSICIAN USED TWO IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERS TO TREAT A LESION LOCATED IN THE SFA/POPLITEAL OF THE LEFT LEG. DEVICES WERE SUCCESSFUL. TWO COMPLETE SE STENTS WERE ALSO IMPLANTED TO TREAT PERSISTENT RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. APPROXIMATELY 10 MONTHS POST THE INDEX PROCEDURE IT IS REPORTED THE PATIENT SUFFERED FROM OCCLUSION OF THE TARGET LESION IN THE LEFT LEG. INVESTIGATOR INDICATED THE EVENT WAS DEFINITELY RELATED TO THE DEVICE AND PROCEDURE. NO TREATMENT WAS GIVEN AND THE OUTCOME OF THE EVENT IS CURRENTLY ONGOING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT APPROXIMATELY 12 MONTHS POST THE INDEX PROCEDURE THE PATIENT SUFFERED FROM NECROSIS OF THE IV LEFT TOE. MINOR AMPUTATION OF THE LEFT LIMB WAS CARRIED OUT 5 DAYS LATER. IT WAS NOT ASSESSED IF THE AMPUTATION WAS RELATED TO THE STUDY DEVICE. THE EVENT WAS UNRESOLVED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED WORSENED CONDITION OF THE LEFT LEG. INVESTIGATOR ASSESSED THE EVENT TO BE DEFINITELY RELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. THE PATIENT UNDERWENT MAJOR LIMB AMPUTATION OF THE LEFT LIMB APPROXIMATELY 2 WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147000 COMPLETE SE SFA STENT, SUPERFICIAL FEMORAL ARTERY NIP MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention