BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST MESH

    MDR report key: 15938634 · Received December 8, 2022

    Report

    Report Number
    1213643-2022-00776
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 18, 2022
    Report Date
    November 22, 2022
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741031656
    PMA / PMN Number
    K101851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF PHOTOS PROVIDED BY THE USER SHOW THE MESH WAS MARKED WITH SURGICAL INK PRIOR TO ATTEMPTED USE. THE HYDROGEL IS BALLED/CLUMPED UP AND SEPARATED IN SECTIONS ON THE CENTER OF THE MESH. ON ONE SIDE OF THE MESH, IT APPEARS THAT THE MESH FIBER IS PULLED AND STRETCHED FROM HANDLING. BASED ON THE INFORMATION PROVIDED AND WITHOUT HAVING THE PHYSICAL SAMPLE TO EVALUATE, NO DEFINITIVE CONCLUSIONS CAN BE MADE. HOWEVER, THE HANDLING OF THE MESH DURING/AFTER HYDRATION MAY HAVE BEEN A CONTRIBUTING FACTOR. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MADE TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FOR THIS MANUFACTURING LOT OF 210 UNITS RELEASED FOR DISTRIBUTION IN SEPTEMBER 2021. PER THE INSTRUCTIONS-FOR-USE (IFU) THE ¿VENTRALIGHT¿ ST MESH SHOULD BE HYDRATED FOR NO MORE THAN 1-3 SECONDS JUST PRIOR TO LAPAROSCOPIC PLACEMENT. IF SUTURES ARE BEING PLACED, ATTACH THE SUTURES TO THE VENTRALIGHT¿ ST MESH BEFORE HYDRATION. THE MESH MUST BE ROLLED IMMEDIATELY AFTER HYDRATION ABOUT ITS LONG AXIS (LENGTHWISE) WITH THE BIORESORBABLE COATING INSIDE TO PROTECT THE BIORESORBABLE COATING. A MINIMUM SIZED TROCAR IS RECOMMENDED FOR THE LAPAROSCOPIC DELIVERY OF VENTRALIGHT¿ ST MESH. INSERT THE MESH THROUGH THE TROCAR USING A RIGID INSTRUMENT, SUCH AS NON-SERRATED, 5 MM FORCEPS; DO NOT OVER FORCE THE MESH 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. NOTE, THE TROCAR SIZE USED IN THIS PROCEDURE WAS NOT PROVIDED, THE MINIMUM TROCAR SIZE PER THE IFU FOR PRODUCT CODE USED (5954680) IS 10MM. NOT RETURNED.

    Description of Event or Problem · 0

    AS REPORTED, DURING A ROBOTIC INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE SEPRA COATING OF A BARD/DAVOL VENTRALIGHT ST CAME OFF WHEN DIPPED INTO SALINE FOR 1-3 SECONDS. AS REPORTED, THE SURGEON HAD TO GET ANOTHER MESH IN THE MIDDLE OF THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447801 VENTRALIGHT ST MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUFU2377 00801741031656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other