BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLIGATOR RETRIEVAL DEVICE

    MDR report key: 3954987 · Received July 24, 2014

    Report

    Report Number
    2029214-2014-00437
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS BEEN RETURNED AND THE EVALUATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF ABERRANT HEART VESSELS. ON (B)(6) 2014, THE PATIENT UNDERWENT A PROCEDURE TO OCCLUDE ABERRANT VESSELS IN THE HEART USING NBCA (CODMAN TRUFILL) GLUE DELIVERED VIA APOLLO CATHETER. THIS WAS THE PATIENT'S THIRD OR FOURTH STAGE. NEAR THE END OF THE PROCEDURE, IT WAS REPORTED THE GLUE CAME OUT OF THE TARGET VESSEL AND DRIFTED DOWNSTREAM. A SNARE AND ALLIGATOR RETRIEVAL DEVICE WAS USED TO ATTEMPT TO GRASP HOLD OF THE GLUE FRAGMENT, BUT THE ALLIGATOR APPEARED TO HAVE STRETCHED. THE PHYSICIAN WAS ABLE TO GRAB THE GLUE SEGMENT WITH THE SNARE IN THE DISTAL HEART VESSEL AND CARRIED IT TO THE GROIN SHEATH WHERE THE GLUE FRAGMENT FELL OUT OF THE SNARE AND COULD NOT BE RECAPTURED. IT WAS NOTED THAT ONE OF THE PHYSICIANS OBSERVED A BROKEN PIECE OF THE ALLIGATOR RETRIEVAL DEVICE IN THE PATIENT. THE ALLIGATOR WAS SAID TO BE RETURNING WITH THREE CLAWS. POST PROCEDURE, THE PATIENT WAS OBSERVED FOR LEFT FEMORAL OCCLUSION AND WILL REQUIRE VASCULAR SURGERY TO REMOVE THE NBCA FROM THE FEMORAL ARTERY IF OCCLUSION OCCURS. ON (B)(6) 2014, THE PHYSICIAN STATED THAT THERE WILL BE NO ATTEMPTS TO REMOVE THE PIECE FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434822 ALLIGATOR RETRIEVAL DEVICE FOREIGN BODY RETRIEVAL DQY EV3 NEUROVASCULAR FA-88810-50 9727626

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention| S