BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 9780044 · Received March 3, 2020

    Report

    Report Number
    2024168-2020-01937
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    December 24, 2019
    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
    KS
    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.

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL SUPERA STENT REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS AND/OR COMPLAINTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED STENT FRACTURE. IT MAY BE POSSIBLE THAT THE SUPERA STENT WAS SUBJECTED TO STRESS/FATIGUE OR REPETITIVE MOVEMENT DUE TO ANATOMICAL CONDITIONS AND LOCATION OF THE IMPLANT; HOWEVER, THIS COULD NOT BE CONFIRMED. THE ADDITIONAL PATIENT EFFECTS AND TREATMENTS INCLUDING SURGERY WERE DUE TO CASE CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    THIS EVENT WAS INITIALLY REPORTED THROUGH A PRESENTATION TITLED, ¿RELINING OF GARDENER¿S STENT FRACTURE (SUPERA TM STENT) IN POPLITEAL ARTERY¿. IT WAS REPORTED THAT ON (B)(6) 2019, A PERCUTANEOUS PERIPHERAL INTERVENTION WAS PERFORMED ON THE POPLITEAL ARTERY. LESION PREPARATION WAS PERFORMED VIA ASPIRATION AND ROTAREX THROMBECTOMY. FOLLOWING, A 6.5X100MM SUPERA STENT (42065100-120, 8080661) WAS IMPLANTED WITHOUT A DEVICE ISSUE. POST-DILATATION WAS PERFORMED. ON (B)(6) 2019, THE 6.5X100MM SUPERA STENT HAD A FRACTURE, ALMOST SEPARATING INTO TWO PIECES. THE LUMEN REMAINED PATENT. ON (B)(6) 2019, THE 6.5X100MM SUPERA STENT HAD A THROMBOTIC TOTAL OCCLUSION. ON (B)(6) 2019, ANOTHER PERCUTANEOUS PERIPHERAL INTERVENTION WAS PERFORMED. ROTAREX THROMBECTOMY AND A SECOND SUPERA STENT, A 6.5X150MM SUPERA STENT (42065150-120, 9051561) WAS IMPLANTED WITHOUT A DEVICE ISSUE. POST-DILATATION WAS PERFORMED. ON (B)(6) 2019, THE 6.5X150MM SUPERA STENT HAD FRACTURED, ALMOST SEPARATING INTO TWO PIECES. DUE TO THE SUPERA STENT FRACTURES, THE PATIENT HAD EXPERIENCED CALF PAIN AND CLAUDICATION. ON (B)(6) 2020, THE PATIENT HAD A FEMORAL-TIBIAL BYPASS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244076 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR 9051561

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 1 SUPERA STENT