BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POUNCE ¿ THROMBECTOMY

    MDR report key: 18422665 · Received December 29, 2023

    Report

    Report Number
    3014687026-2023-00008
    Event Type
    Injury
    Date Received
    December 29, 2023
    Date of Event
    April 30, 2023
    Report Date
    December 29, 2023
    Manufacturer
    SURMODICS INC
    Product Code
    QEW
    PMA / PMN Number
    K192814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: TO DATE, THE DEVICE HAD NOT BEEN RETURNED. IF RETURNED, A SUPPLEMENTAL MDR WILL BE SUBMITTED FOR ANALYSIS RESULTS.

    Description of Event or Problem · 0

    THE PATIENT PRESENTED ON (B)(6) 2023 WITH AN OCCLUSION OF LEFT POPLITEAL AND TIBIAL ARTERIES. THE DEVICE WAS ADVANCED TO THE ANTERIOR TIBIAL ARTERY ORIGIN AND THROMBECTOMY WAS PERFORMED ON THE POPLITEAL ARTERY. THE DEVICE WAS ABLE TO REMOVE PORTIONS OF SUBACUTE THROMBUS AND A MIX OF PLAQUE AND INTIMA. ADDITIONAL PASSES WERE PERFORMED INTO THE DISTAL POSTERIOR TIBIAL AND LARGE PIECES OF THROMBOTIC MATERIAL WERE REMOVED. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED ON THE POSTERIOR TIBIAL AND FLOW WAS SEEN THROUGHOUT THE MAJORITY OF THE POSTERIOR TIBIAL ARTERY. DURING THE FINAL PASS OF DEVICE(APPROXIMATELY 6 OR 7 PASSES TOTAL), THERE WAS SIGNIFICANT RESISTANCE AND DIFFICULTY PULLING THE SYSTEM INTO THE SHEATH. SUBSEQUENT ANGIOGRAMS SHOWED POOR FLOW THROUGH THE SUPERFICIAL FEMORAL ARTERY (SFA). A DISSECTION WAS IDENTIFIED AND STENTED USING 5X100 BARE METAL STENT AND POST DILATED TO 4MM. PLAN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED USING A 3MM BALLOON TO THE TIBIAL-FIBULAR TRUNK (TPT) AND A 4MM BALLOON TO THE POPLITEAL. THERE WAS SLUGGISH FLOW THROUGH THE SEGMENT, BUT IT WAS PATENT. THERE WAS FAINT SIGNAL IN THE POSTERIOR TIBIAL (PT) ARTERY. NO FURTHER TREATMENT WAS PERFORMED AND THE OPERATOR NOTED A HIGH RISK FOR REOCCLUSION. THE PATIENT THEN PRESENTED ON (B)(6) 2023 WITH RECURRENT THROMBOSIS OF THE LEFT SFA, POPLITEAL, TPT, AND PT. AN OPEN THROMBECTOMY WAS PERFORMED. THE ISSUE RESULTED IN A SURGICAL BYPASS OF THE LEFT FEMORAL ARTERY TO THE TIBIAL ARTERY. FLOW WAS SUCCESSFULLY RE-ESTABLISHED. THE SITE ATTRIBUTED THE REPORTED ISSUE RELATED TO THE STUDY DEVICE AND PROCEDURE. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240685 POUNCE ¿ THROMBECTOMY Peripheral mechanical thrombectomy with aspiration QEW SURMODICS INC PTS-0607-7F135 FG220016

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention| O