BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERSACROSS ACCESS SOLUTION

    MDR report key: 22036838 · Received May 16, 2025

    Report

    Report Number
    2124215-2025-31557
    Event Type
    Death
    Date Received
    May 16, 2025
    Date of Event
    June 22, 2023
    Report Date
    May 16, 2025
    Manufacturer
    BAYLIS MEDICALE CIE INC
    Product Code
    DXF
    PMA / PMN Number
    K150709
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD B3: DATE OF EVENT WAS UPDATED WITH ESTIMATED DATE AS 22JUN2023, SINCE AOI HAS NO SPECIFIC PROCEDURE DATE, DATE OF WHEN AOI WAS PUBLISHED WAS USED AS EVENT DATE. 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. 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. ARTICLE CITATION: DOSHI, S. N., SAVVOULIDIS, P., MECHERY, A., LAWTON, E., AND NADIR, M. A. (2023). VERSACROSS TRANSSEPTAL SYSTEM FOR MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR WITH THE PASCAL REPAIR PLATFORM. STRUCTURAL HEART, 7(6), 100203. HTTPS://DOI.ORG/10.1016/J.SHJ.2023.100203.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE. THE PATIENT PASSED AWAY. PER LITERATURE REVIEW, IT WAS REPORTED THAT: PER LITERATURE REVIEW, THIS IS A SINGLE-CENTER RETROSPECTIVE STUDY OF CONSECUTIVE PATIENTS WHO UNDERWENT MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR (MTEER) WITH THE PASCAL (NON-BOSTON SCIENTIFIC DEVICE). TRANSSEPTAL PUNCTURE WAS UNDERTAKEN WITH EITHER A MECHANICAL NEEDLE OR THE VERSACROSS WIRE. THE PRIMARY ENDPOINTS WERE SUCCESS OF TRANSSEPTAL PUNCTURE (TSP) AND SUCCESSFUL DELIVERY OF THE EDWARDS SHEATH ON THE CHOSEN DELIVERY WIRE. SECONDARY ENDPOINTS INCLUDED NUMBER OF WIRES USED, TAMPONADE RATE, INTERVAL FROM FEMORAL VENOUS ACCESS TO TSP AND FIRST PASCAL DEVICE DEPLOYMENT, PROCEDURAL DEATH, AND STROKE. BETWEEN MARCH 2021 AND OCTOBER 2022, 33 CONSECUTIVE M-TEER CASES WERE IDENTIFIED. THIRTY-THREE CONSECUTIVE PATIENTS (10 WITH MECHANICAL NEEDLE, 23 WITH VERSACROSS) WHO UNDERWENT MTEER WITH THE EDWARDS PASCAL DEVICE WERE IDENTIFIED. ALL PATIENTS HAD SUCCESSFUL TSP. IN THE VERSACROSS ARM, THE RADIOFREQUENCY WIRE WAS USED SUCCESSFULLY FOR DELIVERY OF THE SHEATH IN ALL CASES. THERE WERE NO CASES OF PERICARDIAL EFFUSION/TAMPONADE IN EITHER ARM. INTERVAL FROM FEMORAL VENOUS ACCESS TO TSP AND TO DEPLOYMENT OF THE FIRST PASCAL DEVICE WAS SHORTER WITH THE VERSACROSS SYSTEM. SIGNIFICANTLY FEWER WIRES WERE USED WITH VERSACROSS. IN THE MECHANICAL NEEDLE GROUP, SIGNIFICANTLY MORE GUIDEWIRES WERE REQUIRED IN THE PROCEDURE. THERE WERE NO PROCEDURAL STROKES OR DEATHS. ONE LATE STROKE OCCURRED IN THE VERSACROSS GROUP AT 36 HOURS POST MTEER. THE SAME PATIENT SUBSEQUENTLY DIED BEFORE DISCHARGE. THE EMBOLIC STROKE WAS NOT DEEMED TO BE RELATED TO THE VERSACROSS DEVICE AND WAS ATTRIBUTED TO ATRIAL FIBRILLATION, A DIFFICULT PROCEDURE WITH MULTIPLE REPOSITIONINGS, AND THE PASCAL DEVICE ITSELF. THERE WERE NO PROCEDURAL DEATHS OR STROKES IN EITHER GROUP. IN CONCLUSION, VERSACROSS APPEARS A SAFE AND EFFECTIVE METHOD OF TSP AND FOR DELIVERY OF THE 22FR SHEATH FOR M-TEER WITH PASCAL. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. ARTICLE CITATION: DOSHI, S. N., SAVVOULIDIS, P., MECHERY, A., LAWTON, E., AND NADIR, M. A. (2023). VERSACROSS TRANSSEPTAL SYSTEM FOR MITRAL TRANSCATHETER EDGE-TO-EDGE REPAIR WITH THE PASCAL REPAIR PLATFORM. STRUCTURAL HEART, 7(6), 100203. HTTPS://DOI.ORG/10.1016/J.SHJ.2023.100203.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103279 VERSACROSS ACCESS SOLUTION CATHETER, SEPTOSTOMY DXF BAYLIS MEDICALE CIE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death