BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 9777335 · Received March 2, 2020

    Report

    Report Number
    2024168-2020-01927
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    November 29, 2017
    Report Date
    July 22, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA.NA - ATTACHMENT: [CN-024282.PDF].

    Additional Manufacturer Narrative · 0

    B3, D6: ESTIMATED. D4: THE UNIQUE DEVICE IDENTIFIER (UDI) NUMBER IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE PART AND LOT NUMBERS WERE NOT REPORTED. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECT OF WORSENING CLAUDICATION IS LISTED IN THE SUPERA INSTRUCTIONS FOR USE (IFU) AS A KNOWN POTENTIAL PATIENT EFFECT OF PERIPHERAL PERCUTANEOUS INTERVENTION. A DEFINITIVE CAUSE FOR THE REPORTED CLAUDICATION, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. A DEFINITIVE CAUSE FOR THE REPORTED STENT SEPARATION COULD NOT BE DETERMINED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. H6: PATIENT CODE 2199 REMOVED.

    Additional Manufacturer Narrative · 1

    DATES OF EVENT, TESTS, AND IMPLANT: ESTIMATED DATES. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A LITERATURE ARTICLE, THAT THE PATIENT PRESENTED WITH A NON-HEALING WOUND ON HIS RIGHT SHIN WITH RIGHT LEG CLAUDICATION WHEN WALKING 10-15 MINUTES. PER ANGIOGRAM, 100% OCCLUSION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A THROMBECTOMY WAS PERFORMED AND A 6.0X80MM SUPERA STENT WAS IMPLANTED WITHOUT DEVICE ISSUES REPORTED. APPROXIMATELY 3 WEEKS LATER, THE PATIENT PRESENTED WITH RIGHT LEG CLAUDICATION. PER IMAGING, A STENT FRACTURE WITH COMPLETE TRANSSECTION AND GAP BETWEEN THE SEGMENTS WAS OBSERVED. THE FINDINGS WERE CONSISTENT WITH ADVENTITIAL CYSTIC DISEASE (ACD) OF THE POPLITEAL ARTERY AS THE CAUSE OF THE POPLITEAL ARTERY OCCLUSION. THE PATIENT WAS REFERRED FOR A RIGHT FEMORAL-POPLITEAL BYPASS. REPORTEDLY, THE PATIENT IS DOING WELL AT THE 6-MONTH FOLLOW-UP. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE. DETAILS ARE PROVIDED IN THE ATTACHED ARTICLE "ADVENTITIAL CYSTIC DISEASE OF THE POPLITEAL ARTERY CONTRIBUTING TO SUPERA STENT FRACTURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240107 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR UNKNOWN SUPERA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention| S