BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP

    MDR report key: 14292447 · Received May 5, 2022

    Report

    Report Number
    3011706110-2022-00013
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 4, 2022
    Manufacturer
    ATRICURE, INC.
    Product Code
    PZX
    UDI-DI
    30840143900246
    PMA / PMN Number
    K210293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE PROV50 DEVICE, LOT NUMBER 115672, WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCE OR REWORKS WERE NOTED DURING THE MANUFACTURING PROCESS THAT RELATE TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A PATIENT UNDERWENT AN OFF-PUMP, LEFT ATRIAL APPENDAGE MANAGEMENT (LAAM) SURGICAL PROCEDURE. THE PHYSICIAN PLACED A PROV50 CLIP, BUT THE CLIP WAS NOT DEPLOYED AT BASE OF LAA PER TEE MULTIANGLE VIEW. THE PHYSICIAN READJUSTED THE CLIP POSITION AND BLEEDING WAS OBSERVED NEAR THE LAA. THE CAUSE OF THE BLEED WAS UNDETERMINED AND THE PHYSICIAN NOTED THAT THE PATIENT HAD FRIABLE TISSUE. THE BLEEDING DID NOT STOP POST CLIP DEPLOYMENT, SO THE PHYSICIAN PERFORMED A STERNOTOMY. SURGEON PLACED A SECOND PROV50 ON THE BASE OF THE LAA UNDER DIRECT VISUALIZATION TO CONTROL BLEEDING. THE BLEEDING SLOWED BUT DID NOT STOP, SO PATIENT WAS PUT ONTO CPB TO GET HEMOSTASIS. THE BLEED WAS REPAIRED AND HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS STABLE POST-PROCEDURE. THIS WAS A PROCEDURAL COMPLICATION WITH NO REPORTED DEVICE MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570151 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP PZX ATRICURE, INC. PROV50 115672 30840143900246

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Life Threatening| R PROV50