BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO MESH

    MDR report key: 14515355 · Received May 26, 2022

    Report

    Report Number
    1213643-2022-00348
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    May 22, 2018
    Report Date
    May 16, 2022
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    UDI-DI
    00801741016394
    PMA / PMN Number
    K100229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, ABOUT 2.2 YEARS POST-IMPLANT OF THE VENTRIO HERNIA PATCH, THE PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND UNDERWENT SURGICAL REPAIR. AS REPORTED, THE AE HAS RESOLVED. THE CLINICIAN HAS ASSESSED THE PATIENT¿S POSTOPERATIVE COURSE AS BEING ¿POSSIBLY¿ RELATED TO THE STUDY DEVICE AND TO THE INDEX PROCEDURE, HOWEVER, BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE. HERNIA RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY. THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE LISTS HERNIA RECURRENCE AS A POSSIBLE COMPLICATION. REVIEW OF MANUFACTURING RECORDS CONFIRMS PRODUCT WAS MANUFACTURED TO SPECIFICATION. THIS MDR REPRESENTS THE ADVERSE EVENT OF RECURRENT HERNIA THAT OCCURRED ON (B)(6) 2018. AN ADDITIONAL MDR WAS SUBMITTED TO REPRESENT THE ADVERSE EVENT OF RECURRENT HERNIA THAT OCCURRED ON (B)(6) 2019. NOT RETURNED.

    Description of Event or Problem · 0

    REPORTED PER CLINICAL TRIAL (B)(6): ON (B)(6) 2016 - SUBJECT PATIENT UNDERWENT MULTIPLE RECURRENT VENTRAL HERNIA REPAIR IN THE LEFT LOWER QUADRANT (LLQ) USING A BARD/DAVOL VENTRIO HERNIA PATCH. FASCIA CLOSURE WAS PERFORMED AND SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE PATIENT WAS DISCHARGED ON THE SAME DAY. ON (B)(6) 2018 - SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT INCISIONAL HERNIA DURING A PHYSICAL EXAM. ON (B)(6) 2018 - SUBJECT PATIENT UNDERWENT VENTRAL HERNIA (LLQ) REPAIR PROCEDURE FOR HERNIA RECURRENCE. THE PATIENT WAS DISCHARGED ON SAME DAY. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED. ON (B)(6) 2019 - SUBJECT PATIENT WAS DIAGNOSED WITH A RECURRENT INCISIONAL HERNIA. ON (B)(6) 2019 - SUBJECT PATIENT UNDERWENT VENTRAL HERNIA REPAIR PROCEDURE IN THE LEFT LOWER QUADRANT (LLQ), DURING WHICH THE MESH WAS EXPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MODERATE IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711434 VENTRIO MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA HUYJ0218 00801741016394

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Hospitalization| R