BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA

    MDR report key: 11387973 · Received February 26, 2021

    Report

    Report Number
    2024168-2021-01517
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 19, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    PMA / PMN Number
    P120020
    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. 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. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. IT MAY BE POSSIBLE THAT ANATOMICAL CONDITIONS CONTRIBUTED TO THE DIFFICULTY; HOWEVER, THIS COULD NOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.NA.

    Additional Manufacturer Narrative · 1

    THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. 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.

    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
    285840 SUPERA SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR UNKNOWN SUPERA

    Patients

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