BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7299205 · Received February 27, 2018

    Report

    Report Number
    1213643-2018-00394
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    June 12, 2015
    Report Date
    October 9, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031496
    PMA / PMN Number
    K101928
    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 #1 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 RECURRENT HERNIA AFTER THE VENTRALEX ST HERNIA MESHES FAILED AND TO REMOVE ALL THREE VENTRALEX ST HERNIA PATCHES" HOWEVER THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. 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 DATE OF EVENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 1 YEAR 1 MONTH POST IMPLANT OF TWO VENTRALEX ST, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ADHESIONS AND MESH DEFORMATION THEREBY UNDERWENT REPAIR WITH THE REMOVAL OF MESH. PER OP NOTES, "MESH APPEARED TO HAVE ROLLED UP UPON ITSELF". THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST ADHESIONS AS A POSSIBLE COMPLICATION. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. THIS SUPPLEMENTAL EMDR REPRESENTS VENTRALEX ST (DEVICE #1). ADDITIONAL SUPPLEMENTAL EMDR'S WERE SUBMITTED TO REPRESENT VENTRALEX ST (DEVICE #2 & #3). 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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2014: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA AND UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #1), REFERENCE NUMBER 5950009, LOT NUMBER HUXC1026 WAS IMPLANTED TO REPAIR THE INCISIONAL VENTRAL HERNIA DEFECT AND A BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #2), REFERENCE NUMBER 5950008, LOT NUMBER HUXK0926 WAS IMPLANTED TO REPAIR THE UMBILICAL HERNIA DEFECT. (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #3), REFERENCE NUMBER 5950008, LOT NUMBER HUYK0637, WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE VENTRALEX ST HERNIA MESHES FAILED AND TO REMOVE ALL THREE VENTRALEX ST HERNIA PATCHES. 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 ST HERNIA PATCH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA AND INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO VENTRALEX ST (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿HERNIA WAS IDENTIFIED. A LARGE VENTRALEX ST (DEVICE #1) WAS PLACED INTO THE ABDOMINAL CAVITY. AT THIS POINT THE UMBILICAL DEFECT WAS CLEARED OF THIS PREPERITONEAL FAT AND A MEDIUM VENTRALEX ST (DEVICE #2) WAS PLACED INTO THE ABDOMINAL WALL USING STAYS.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #3). PER OPERATIVE NOTES, ¿THE PREVIOUSLY PLACED MESH APPEARED TO HAVE ROLLED UP UPON ITSELF AND THIS WAS REDUCIBLE. A VENTRALEX ST (DEVICE #3) WAS PLACED USING SUTURES.¿ (B)(6) 2016 - PATIENT VISITED HOSPITAL FOR RECURRENT ABDOMINAL INCISIONAL HERNIA. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF ALL MESHES (DEVICE #1, #2 & #3). PER OPERATIVE NOTES, ¿THERE WERE THREE PIECES OF MESH IN TOTAL. THE INFERIOR MESH WAS ADHERENT TO THE ABDOMINAL WALL, LARGEST MID PIECE WAS PARTIALLY ADHERENT IN THE LEFT LATERAL POSITION, AND THE SUPERIOR WAS FREE FLOATING IN THE OMENTUM. EXCISED THE PERITONEAL SURFACE, EVISCERATED THE MESH PATCHES AND IT WAS REMOVED FROM THE OMENTUM. A SYNTHETIC MESH WAS PLACED AND SECURED WITH SUTURES.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, HERNIA RECURRENCE, MESH MIGRATION 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 #1 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 RECURRENT HERNIA AFTER THE VENTRALEX ST HERNIA MESHES FAILED AND TO REMOVE ALL THREE VENTRALEX ST HERNIA PATCHES" HOWEVER THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. 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. THIS EMDR REPRESENTS THE BARD DEVICE #1 IMPLANTED TO REPAIR INCISIONAL HERNIA ON (B)(6) 2014. AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD DEVICE #2 IMPLANTED TO REPAIR UMBILICAL HERNIA ON (B)(6) 2014 AND BARD DEVICE #3 IMPLANTED TO REPAIR A VENTRAL HERNIA ON (B)(6) 2015. 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) 2014: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA AND UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #1), REFERENCE NUMBER 5950009, LOT NUMBER HUXC1026 WAS IMPLANTED TO REPAIR THE INCISIONAL VENTRAL HERNIA DEFECT AND A BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #2), REFERENCE NUMBER 5950008, LOT NUMBER HUXK0926 WAS IMPLANTED TO REPAIR THE UMBILICAL HERNIA DEFECT. ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #3), REFERENCE NUMBER 5950008, LOT NUMBER HUYK0637, WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE VENTRALEX ST HERNIA MESHES FAILED AND TO REMOVE ALL THREE VENTRALEX ST HERNIA PATCHES. 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 ST HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143435 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUXC1026 00801741031496

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Disability| R