BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT SUPERA STENT SELF-EXPANDING

    MDR report key: 10991907 · Received December 10, 2020

    Report

    Report Number
    MW5098322
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    November 12, 2020
    Report Date
    December 9, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 4.5 MM X 100 MM ABBOTT SUPERA SELF-EXPANDING STENT REFERENCE NUMBER (S-45-100-120-P6) LOT # 9040461 EXPIRATION 2021-03-31 WAS DEPLOYED IN A HEAVILY CALCIFIED BELOW KNEE POPLITEAL ARTERY AFTER BALLOON ANGIOPLASTY. PRE DILATATION WITH A 4MM X 15 CM ABBOTT BALLOON TO 4.3MM WAS PERFORMED OVER A V-18 CONTROL WIRE. SIGNIFICANT RESIDUAL STENOSIS WAS NOTED; THEREFORE, THE DECISION WAS MADE TO USE A SELF-EXPANDING SUPERA STENT. A SELF-EXPANDING STENT WAS DEPLOYED ACROSS THE STENOSIS. WHILE ADVANCING A BALLOON TO PERFORM POST-DEPLOYMENT DILATATION, IT WAS NOTED THAT THE TIP OF THE DELIVERY SYSTEM HAD BECOME DETACHED IN THE DISTAL ARTERY STILL ON THE GUIDEWIRE. ULTIMATELY, WE WERE ABLE TO PASS A 4MM SNARE DISTAL TO THE CATHETER TIP, PASS THE .018 GUIDEWIRE THROUGH THE SNARE, AND THEN PULL THE SNARE BACK OVER THE CATHETER TIP AND PULLED THE CATHETER TIP BACK INTO THE 6 FR DELIVERY SHEATH. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454332 ABBOTT SUPERA STENT SELF-EXPANDING STENT, SUPERFICIAL FEMORAL ARTERY NIP ABBOTT VASCULAR REF: S-45-100-120-P6 LOT: 9040461

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention