BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO MESH

    MDR report key: 7290687 · Received February 22, 2018

    Report

    Report Number
    1213643-2018-00359
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    July 14, 2015
    Report Date
    October 21, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016387
    PMA / PMN Number
    K100229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. TO DATE NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH." MEDICAL RECORDS WERE NOT PROVIDED AND THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR REASON FOR EXPLANT. THE DESCRIPTION DOES NOT CLEARLY DEFINE 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: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT MANUFACTURING DATE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 1 YEARS 8 MONTHS POST IMPLANT OF VENTRIO MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE AND ADHESIONS THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS ADHESIONS AS A POSSIBLE COMPLICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. THIS SUPPLEMENTAL EMDR REPRESENTS THE VENTRIO MESH (DEVICE #1). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE VENTRALIGHT ST W/ ECHO (DEVICE #2). 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 HAD A BARD/DAVOL VENTRIO HERNIA PATCH, PRODUCT CODE 0010211, LOT NUMBER HUXG1010 IMPLANTED TO REPAIR A VENTRAL HERNIA DEFECT. (B)(6)2015: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6)2013 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA WAS IDENTIFIED JUST TO THE RIGHT OF THE MIDLINE. A VENTRIO HERNIA PATCH (DEVICE#1) WAS THEN PLACED INTRAABDOMINALLY USING SUTURES. ¿ (B)(6)2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #2) AND REMOVAL OF VENTRIO MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE ADHESIONS WERE TAKEN DOWN FROM THE ANTERIOR ABDOMINAL WALL. THE VENTRIO MESH (DEVICE #1) WAS LOOSE AND CURLED UP AND THIS VENTRIO MESH (DEVICE #1) WAS REMOVED. THEN A VENTRALIGHT ST USING ECHO PS (DEVICE #2) WAS PLACED INTO THE ABDOMEN USING TACKERS.¿ (B)(6)2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #3). PER OPERATIVE NOTES, ¿THE LOWER EDGE OF THE OLD MESH (DEVICE #2) HAD TENTED UP INTO THE HERNIA. THE ADHESIONS WERE LYSED, THEN AN ANOTHER VENTRALIGHT ST USING ECHO PS MESH (DEVICE #3) WAS USED FOR REPAIR AND SECURED BY TACKERS.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, MESH MIGRATION, MESH SHRINKAGE, PAIN, HERNIA RECURRENCE AND EMOTIONAL INJURIES. IT IS ALSO ALLEGED THAT THE PATIENT HAD ADDITIONAL SURGERY TO REMOVE THE MESH AND REPAIR THE HEMIA, PERMANENT AND SEVERE SCARRING AND DISFIGUREMENT.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. TO DATE NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH." MEDICAL RECORDS WERE NOT PROVIDED AND THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR REASON FOR EXPLANT. THE DESCRIPTION DOES NOT CLEARLY DEFINE 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 HAD A BARD/DAVOL VENTRIO HERNIA PATCH, PRODUCT CODE 0010211, LOT NUMBER HUXG1010 IMPLANTED TO REPAIR A VENTRAL HERNIA DEFECT. ON (B)(6) 2015: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE THE MESH. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134483 VENTRIO MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXG1010 00801741016387

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Disability| R