BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 11387956 · Received February 26, 2021

    Report

    Report Number
    2024168-2021-01518
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 21, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    UDI-DI
    08717648211836
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 INDICATION OF A LOT SPECIFIC PRODUCT QUALITY ISSUE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. IT MAY BE POSSIBLE THAT THE PROXIMAL END OF THE SUPER A STENT WAS PARTIALLY DEPLOYED WITHIN THE INTRODUCER SHEATH RESULTING IN RESISTANCE DURING REMOVAL AND ELONGATION OF THE STENT. ADDITIONALLY, IT MAY BE POSSIBLE THAT DURING THE ATTEMPTS TO RELEASE THE STENT FROM THE INTRODUCER SHEATH AND/OR DELIVERY SYSTEM, THE TIP SEPARATION OCCURRED; HOWEVER, THIS COULD NOT BE CONFIRMED. THE UNEXPECTED MEDICAL INTERVENTION TO RETRIEVE THE SEPARATED TIP WAS RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER SUPERA STENT REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT.NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 A SUPERA STENT WAS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). ON (B)(6) 2021, THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT POPLITEAL ARTERY. THE VESSEL DIAMETER WAS 6MM. A 6MM ANGIOPLASTY BALLOON WAS USED TO PREP THE VESSEL. THE 6.0X120MMX120CM SUPERA SELF-EXPANDING STENT SYSTEM (SESS) (LOT# 9061961) WAS ADVANCED TO THE TARGET LESION AND DEPLOYED. RESISTANCE WAS NOTED DURING REMOVAL OF THE SESS. TROUBLESHOOTING WAS PERFORMED; THE INTRODUCER SHEATH HAD TO BE PULLED BACK AND THE STENT DEPLOYED BUT WAS ELONGATED AND STRETCHED TO THE PREVIOUSLY IMPLANTED SUPERA STENT, WHICH WAS DIFFICULT TO VISUALIZE. THE TIP OF THE SUPERA DETACHED IN THE SFA BUT REMAINED ON THE GUIDE WIRE. A BALLOON WAS USED TO AID IN REMOVAL OF THE TIP FROM THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281112 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR S-60-120-120-P6 9061961 08717648211836

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention 014" X 315CM BAREWIRE| DESTINATION SHEATH