BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7274654 · Received February 15, 2018

    Report

    Report Number
    1213643-2018-00302
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    March 1, 2016
    Report Date
    September 16, 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 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 RECURRENT HERNIA AFTER THE VENTRALEX ST FAILED AND TO REMOVE THE VENTRALEX ST". MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME AND NO SPECIFIC DEVICE FAILURE IS OR REASON FOR EXPLANT IS 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 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 3 YEARS 5 MONTHS POST IMPLANT OF VENTRALEX ST, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ADHESION AND ABDOMINAL PAIN THEREBY UNDERWENT REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE 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. 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) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER (B)(4), LOT NUMBER HUWF1499 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE RECURRENT HERNIA AFTER THE VENTRALEX ST FAILED AND TO REMOVE THE VENTRALEX ST. 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) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, ¿OMENTAL FAT AND HERNIA WAS TAKEN DOWN WITH THE ADHESIONS, THEN A LARGE VENTRALEX ST MESH WAS UNROLLED AND TACKED TO THE ABDOMINAL WALL.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH COMPLEX HERNIA RECURRENCE THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF VENTRALEX ST (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN AND THE OLD VENTRALEX ST WAS EXCISED. A VERY LARGE PIECE OF VENTRALIGHT ST MESH WAS PLACED AND TACKED TO THE ABDOMINAL WALL.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, 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 THE RECURRENT HERNIA AFTER THE VENTRALEX ST FAILED AND TO REMOVE THE VENTRALEX ST". MEDICAL RECORDS ARE NOT AVAILABLE AT THIS TIME AND NO SPECIFIC DEVICE FAILURE IS OR REASON FOR EXPLANT IS 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. 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) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER 5950009, LOT NUMBER HUWF1499 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE RECURRENT HERNIA AFTER THE VENTRALEX ST FAILED AND TO REMOVE THE VENTRALEX ST. 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
    116368 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUWF1499 00801741031496

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Disability| R