BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 14854612 · Received June 29, 2022

    Report

    Report Number
    3005580113-2022-00071
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    June 2, 2022
    Report Date
    June 29, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    UDI-DI
    10827002574486
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON NAME: QAN. PRODUCT CODE: QAN.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORTER: A FEMALE PATIENT IN HER 60S WITH COMPRESSION OF THE COMMON ILIAC AND EXTERNAL ILIAC VEINS ON RIGHT SIDE UNDERWENT AN IVUS AND VENOGRAPHY PROCEDURE IN WHICH THE ZILVER VENA VENOUS SELF-EXPANDING STENT, G57449 AND G57448, WERE USED. ACCESS SITE WAS RIGHT GROIN AND A IVUS AND VENOGRAPHY WAS PERFORMED. THE PHYSICIAN SELECTED 16X140 VENA TO STENT FROM THE CONFLUENCE INTO THE EXTERNAL ILIAC VEIN ON RIGHT SIDE. NO PREDILATION WAS DONE. AFTER DEPLOYING STENT OPTIMALLY, PHYSICIAN ADVANCED A (ANOTHER MANUFACTURER'S) 16X60 BALLOON INTO THE STENT. THE TECH WHO WAS SCRUBBED IN STATES THE PHYSICIAN WAS NOT STEPPING ON FLUORO WHILE ADVANCING BALLOON, AND ONCE HE DID STEP ON FLUORO BOTH THE PHYSICIAN AND TECH SAW THAT THE STENT HAD ALMOST COMPLETELY, ABOUT 95%, MIGRATED INTO THE PATIENT¿S IVC (REF: (B)(4)). THEY BOTH AGREED THAT THE BALLOON CATHETER BUMPED THE CAUDAL EDGE OF THE STENT AND CAUSED IT TO MIGRATE SIGNIFICANTLY. PHYSICIAN ATTEMPTED TO USE THE BARD ATLAS BALLOON TO PULL THE STENT BACK DOWN INTO THE COMMON ILIAC, BUT WAS UNSUCCESSFUL. THEN, PHYSICIAN DEPLOYED ANOTHER 16X140 VENA INTO COMMON ILIAC, OVERLAPPING THE 2 STENTS A FEW CENTIMETERS. DUE TO STENT MIGRATION, A THIRD STENT, THE 16X100, WAS NEEDED TO EXTEND INTO THE EXTERNAL ILIAC. PHYSICIAN USED SAME 16X60 ATLAS BALLOON TO POST DILATE THE STENTS, AND AS HE WAS ADVANCING THE BALLOON INTO THE 16X100 STENT, THE BALLOON BUMPED INTO THIS STENT ALSO AND CAUSED IT TO JUMP ABOUT 2 CM BUT WAS ABLE TO USE THE BALLOON TO PULL THE STENT BACK DOWN TO ORIGINAL LANDING ZONE (SUBJECT OF THIS REPORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846772 ZILVER VENA VENOUS SELF-EXPANDING STENT QAN COOK IRELAND LTD G57448 C1906325 10827002574486

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention