BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO ST

    MDR report key: 7204029 · Received January 18, 2018

    Report

    Report Number
    1213643-2018-00088
    Event Type
    Injury
    Date Received
    January 18, 2018
    Date of Event
    August 20, 2014
    Report Date
    February 27, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031526
    PMA / PMN Number
    K101920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. ADDITIONALLY, IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH, WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, HOWEVER, RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 8 MONTHS POST IMPLANT OF VENTRIO ST, THIS OBESE PATIENT WAS DIAGNOSED WITH ADHESIONS, MESH MIGRATION, SCAR TISSUE AND HERNIA RECURRENCE THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. PER OP NOTES, "MESH COVERING THE ORIGINAL DEFECT HAD DETACHED FROM THE LEFT SIDE LEAVING A VERY LARGE DEFECT." THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE LIST ADHESIONS AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, B4, B5, B7, D.6B (DATE OF EXPLANT), E3, G1, G3, G6, H2, H6, H10. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : NOT RETURNED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCARCERATED VENTRAL HERNIA. A BARD/DAVOL VENTRIO ST HERNIA PATCH, REFERENCE NUMBER (B)(4), LOT NUMBER HUXD0927 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRIO ST HERNIA PATCH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC CONTAINING INCARCERATED OMENTUM WAS DISSECTED FREE AND IDENTIFIED ANOTHER DEFECT IN THE LEVEL OF UMBILICUS. INTENSE SCAR TISSUE NOTED IN THE MESH AREA WERE COMPLETELY CLEANED. THE TWO DEFECTS WERE COALESCED INTO ONE AND A VENTRIO ST MESH WAS SECURED UNDERNEATH THE FASCIA USING SUTURES.¿ (NOTE, NO PRODUCT IDENTIFIER HAS BEEN PROVIDED FOR THE OLD UNKNOWN MESH) (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE #2) AND EXPLANT OF VENTRIO ST MESH (DEVICE #1). PER OPERATIVE NOTES, "IDENTIFIED SCAR TISSUE AND THE RECURRENT HERNIA SAC WAS DISSECTED. THERE WERE TWO MESHES PRESENT, ONE WAS A UNKNOWN MESH PLUG IN UMBILICAL AREA AND ANOTHER MESH (VENTRIO ST - DEVICE #1) COVERING THE ORIGINAL DEFECT HOWEVER THIS HAD DETACHED FROM THE LEFT SIDE LEAVING A VERY LARGE DEFECT. THE OMENTUM WAS ADHERENT TO THE MESH WERE TAKEN DOWN. WITH PERSEVERANCE, THE EXCESS MESH WAS TRIMMED AND ANOTHER PIECE OF UMBILICAL MESH FROM THE INFERIOR PART WAS ALSO DISSECTED. EXTENSIVE LYSIS OF ADHESIONS WAS PERFORMED UNDERNEATH FASCIA. THEN, A VENTRIO ST MESH (DEVICE #2) WAS PLACED UNDERNEATH THE FASCIA AND SUTURED." ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, HERNIA RECURRENCE, REMOVAL SURGERY AND EMOTIONAL INJURIES.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. ADDITIONALLY, IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH, WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, HOWEVER, RECURRENCE IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATION. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NOT RETURNED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCARCERATED VENTRAL HERNIA. A BARD/DAVOL VENTRIO ST HERNIA PATCH, REFERENCE NUMBER 5950030, LOT NUMBER HUXD0927 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRIO ST HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47689 VENTRIO ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXD0927 00801741031526

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Disability| R