BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST MESH

    MDR report key: 12396526 · Received August 31, 2021

    Report

    Report Number
    1213643-2021-20290
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 10, 2021
    Report Date
    August 13, 2021
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031632
    PMA / PMN Number
    K101851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE SEPRA (ST) COATING OF THE VENTRALIGHT ST MESH SEPARATED DURING ATTEMPTED DEPLOYMENT VIA AN 8MM TROCAR (NOTE, PER THE IFU A 10MM TROCAR IS RECOMMENDED FOR CAT# 5954600). THE SUBJECT PRODUCT WAS RETURNED FOR EVALUATION. EVALUATION OF THE SAMPLE FINDS THE ST COATING TO HAVE SEPARATED FROM AREAS ON THE MESH, RESULTING IN A VOID OF THE HYDROGEL BARRIER. THE SEPARATION OF THE HYDROGEL COATING IS THE RESULT OF THE ATTEMPTED DEPLOYMENT THROUGH THE 8MM TROCAR. THE TROCAR USED IN THE CASE WAS ALSO RETURNED WITH THE MESH SAMPLE AND IS CONFIRMED TO BE AN 8MM TROCAR. BASED ON THE SAMPLE EVALUATION AND INVESTIGATION PERFORMED, THE ROOT CAUSE IS DETERMINED TO BE INADVERTENT DAMAGE TO THE ST HYDROGEL BARRIER DURING USER/DEVICE INTERFACE WHILE HANDLING THE HYDRATED MESH AND DEPLOYING DOWN THE 8MM TROCAR. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT. PER THE LAPAROSCOPIC USE SECTION IN THE INSTRUCTIONS-FOR-USE, ¿A MINIMUM SIZED TROCAR IS RECOMMENDED FOR THE LAPAROSCOPIC DELIVERY OF VENTRALIGHT ST MESH (RECOMMENDED TO USE A 10MM TROCAR FOR CAT# 5954600). INSERT THE PROSTHESIS THROUGH THE TROCAR USING A RIGID INSTRUMENT, SUCH AS NON-SERRATED, 5 MM FORCEPS; DO NOT OVER FORCE THE PROSTHESIS THROUGH TROCAR. IF VENTRALIGHT ST MESH IS HYDRATED LONGER THAN 3 SECONDS AND/OR DOES NOT EASILY DEPLOY DOWN THE TROCAR, REPLACE TROCAR AND RETRY WITH THE NEXT AVAILABLE LARGER SIZED TROCAR."

    Description of Event or Problem · 1

    AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL VENTRALIGHT ST MESH WAS HYDRATED APPROXIMATELY 1-3 SECONDS, ROLLED WITH THE ST COATING INSIDE AND INSERTED THROUGH AN 8 MM TROCAR. AS REPORTED, WHEN THE SURGEON UNROLLED THE MESH, THE ST COATING WAS NOTED TO BE SEPARATING. AS REPORTED, THE MESH WAS REMOVED AND A NON-BARD/DAVOL MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299396 VENTRALIGHT ST MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUFN0308 00801741031632

    Patients

    Seq Age Sex Outcome Treatment
    1 Other