BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    MDR report key: 21841400 · Received April 15, 2025

    Report

    Report Number
    2124215-2025-23553
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    August 1, 2023
    Report Date
    April 15, 2025
    Manufacturer
    BAYLIS MEDICALE CIE INC
    Product Code
    DXF
    PMA / PMN Number
    K150709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. B3: DATE OF EVENT - ESTIMATED AS 01AUGUST 2023 SINCE AOI INVOLVES A COHORT OF PATIENTS AND NO SPECIFIC PROCEDURE DATES WERE PROVIDED, DATE OF WHEN AOI WAS PUBLISHED WAS USED AS EVENT DATE. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. THIS WAS NOT AVAILABLE BECAUSE THIS WAS RELATED TO A LITERATURE STUDY. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. RANA MA, YOON S, DALLAN LAP, ET AL. MIDTERM FOLLOWUP AFTER COMPUTED TOMOGRAPHY ANGIOGRAPHY PLANNED LEFT ATRIAL APPENDAGE CLOSURE. CATHETER CARDIOVASC INTERV. 2024; 103:129 TO 136. DOI:10.1002 CCD.30843.

    Description of Event or Problem · 0

    PER LITERATURE REVIEW, IT WAS REPORTED: PER LITERATURE REVIEW, FROM JANUARY 26, 2017, TO NOVEMBER 23, 2021, 231 PATIENTS UNDERWENT LAAC WITH CTA PREPROCEDURAL PLANNING BY TWO OPERATING PHYSICIANS. ALL PATIENTS HAD CARDIAC COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) USED FOR THE PRE-PROCEDURAL PLANNING. ALL PROCEDURES WERE PERFORMED WITH INTRACARDIAC ECHOCARDIOGRAPHY. ALL PROCEDURES WERE COMPLETED UNDER CONSCIOUS SEDATION. INITIALLY, WE USED WATCHMAN LEGACY DEVICE AND TRANSITIONED TO THE FLX DEVICE AFTER FDA APPROVAL. AN ACTIVATED CLOTTING TIME (ACT) OF OVER250 S WITH IV HEPARIN WAS REQUIRED FOR THE PROCEDURE. ICE IMAGING WAS DONE WITH 8 FR ULTRASOUND NON-BOSTON SCIENTIFIC CATHETERS . THE TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A VERSACROSS TRANSSEPTAL SHEATH SYSTEM. AFTER ICE ADVANCEMENT INTO THE LEFT ATRIUM, THREE ICE VIEWS WERE OBTAINED TO EVALUATE DEVICE DEPLOYMENT, A LEFT UPPER ATRIAL VIEW (ANALOGOUS TO 90 DEGREES TEE VIEW), AN AORTIC VALVE VIEW (ANALOGOUS TO 45 DEGREES TEE VIEW), AND A 'MITRAL INFLOW VIEW' (ANALOGOUS TO 135 DEGREES TEE VIEW) IN WHICH THE PROBE IS RETROFLEXED TOWARD THE MITRAL VALVE LOOKING UP AT THE DEVICE. ICE WAS UTILIZED TO GUIDE TRANSSEPTAL PUNCTURE, ASSESS DEVICE POSITION, EVALUATE COMPRESSION AFTER DEVICE PLACEMENT, AND ASSESS FOR PERICARDIAL EFFUSION PRE AND AND POST PROCEDURE. 'PASS' (POSITION, ANCHOR, SIZE, AND SEAL) CRITERIA FOR DEVICE RELEASE AND TO DEFINE SUCCESSFUL DEVICE DEPLOYMENT. OF THE 231 PATIENTS, 3 PATIENTS EXPERIENCED A PERICARDIAL EFFUSION, 1 DEVICE RELATED THROMBUS (DRT), AND PERI DEVICE LEAK (PDL) WAS NOTED IN 6 PATIENTS DURING FOLLOW UP. IN CONCLUSION, CTA BASED PREPROCEDURAL PLANNING IS ACCURATE IN DEVICE SIZE SELECTION FOR LAAC AND ASSOCIATED WITH EXCELLENT CLINICAL OUTCOMES AT 5 YEARS. GIVEN THE ADVANTAGES OF CTA OVER TEE IN LAAC PLANNING, WE ANTICIPATE INCREASED ADOPTION OF CTA, ESPECIALLY AS PROCEDURE SPECIFIC SOFTWARE BECOMES MORE AVAILABLE. RANA MA, YOON S, DALLAN LAP, ET AL. MIDTERM FOLLOWUP AFTER COMPUTED TOMOGRAPHY ANGIOGRAPHY PLANNED LEFT ATRIAL APPENDAGE CLOSURE. CATHETER CARDIOVASC INTERV. 2024; 103:129 TO 136. DOI:10.1002 CCD.30843.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105347 VERSACROSS CONNECT LAAC ACCESS SOLUTION CATHETER, SEPTOSTOMY DXF BAYLIS MEDICALE CIE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other