BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-VENTRALEX

    MDR report key: 7152262 · Received December 28, 2017

    Report

    Report Number
    1213643-2017-01126
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    November 18, 2015
    Report Date
    December 30, 2023
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741000355
    PMA / PMN Number
    K024008
    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 AN INCARCERATED RECURRENT HERNIA DEFECT, RELEASE ADHESIONS BETWEEN THE PATIENT'S BOWEL AND THE VENTRALEX MESH, 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. ADHESIONS AND RECURRENCE ARE KNOWN INHERENT RISKS OF SURGERY AND ARE IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATIONS. 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 THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 6 YEARS POST IMPLANT OF VENTRALEX MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ADHESIONS, BOWEL OBSTRUCTION AND ABDOMINAL PAIN THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. THIS SUPPLEMENTAL EMDR REPRESENTS THE MESH ¿ VENTRALEX (DEVICE #1). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE XENMATRIX (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) 2011: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. AS REPORTED, A BARD/DAVOL VENTRALEX HERNIA PATCH, REFERENCE NUMBER 0010301, LOT NUMBER HUTJ0629 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2015: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR AN INCARCERATED RECURRENT HERNIA DEFECT, RELEASE ADHESIONS BETWEEN THE PATIENT'S BOWEL AND THE VENTRALEX MESH, 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 VENTRALEX HERNIA PATCH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED FREE AND THE SAC CONTAINING INCARCERATED OMENTUM WAS SEPARATED. FOLLOWING THIS, A VENTRALEX MESH (DEVICE #1) WAS PLACED INSIDE THE ABDOMINAL CAVITY BETWEEN THE OMENTUM AND MUSCLE. THIS WAS TACKED AND SUTURED.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA, SMALL BOWEL OBSTRUCTION AND SEVERE ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF XENMATRIX (DEVICE #2) AND REMOVAL OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿MIDLINE INCISION WAS MADE ABOVE THE PALPABLE INCARCERATED HERNIA TO BELOW THE UMBILICUS. EXTENSIVE ENTEROLYSIS WAS CARRIED OUT FREEING ALL THE BOWEL LOOPS FROM THE ADHERENT MESH FOR THE PREVIOUS INCISIONAL HERNIA REPAIR. THE PREVIOUS MESH (DEVICE #1) WAS EXCISED. THE BOWEL REPAIR WAS THEN CARRIED OUT USING XENMATRIX MESH (DEVICE #2). THIS WAS PLACED ON BOTH EDGES OF THE FASCIA IN UNDERLAY FASHION AND SECURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #3). PER OPERATIVE NOTES, ¿IDENTIFIED TWO DISTINCT AREAS WHERE HERNIATION HAD OCCURRED, ONE WAS ABOVE THE UMBILICUS AND ONE WAS JUST LATERAL TO IT ON THE LEFT SIDE. THE SACS WERE OPENED AND DISSECTED. TOOK DOWN ALL THE ADHESIONS OF THE SMALL INTESTINE AND THE OLD MESH GRAFT (DEVICE #2) WAS FOUND. ONCE THIS WAS DONE, FASCIAL DEFECT THROUGH WHICH THE HERNIAS WERE BOTH PROTRUDING WAS IDENTIFIED. VENTRALEX ST (DEVICE #3) WAS SECURED IT TO THE UNDERSIDE OF THE OLD FASCIA ON THE UNDERSIDE OLD GRAFT (DEVICE #2) WITH SUTURE.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTION, INFECTION, PAIN AND HERNIA RECURRENCE.

    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 AN INCARCERATED RECURRENT HERNIA DEFECT, RELEASE ADHESIONS BETWEEN THE PATIENT'S BOWEL AND THE VENTRALEX MESH, 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. ADHESIONS AND RECURRENCE ARE KNOWN INHERENT RISKS OF SURGERY AND ARE IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS A POSSIBLE COMPLICATIONS. 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) 2011: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. AS REPORTED, A BARD/DAVOL VENTRALEX HERNIA PATCH, REFERENCE NUMBER 0010301, LOT NUMBER HUTJ0629 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2015: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR AN INCARCERATED RECURRENT HERNIA DEFECT, RELEASE ADHESIONS BETWEEN THE PATIENT'S BOWEL AND THE VENTRALEX MESH, 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 VENTRALEX HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930768 MESH-VENTRALEX SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUTJ0629 00801741000355

    Patients

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