BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7302417 · Received February 28, 2018

    Report

    Report Number
    1213643-2018-00403
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    February 23, 2017
    Report Date
    October 10, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031489
    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 FAILED AND TO REMOVE THE VENTRALEX ST"; HOWEVER THE DESCRIPTION DOES NOT CLEARLY DEFINE IF THE VENTRALEX ST REMOVED REFERS TO DEVICE #1, DEVICE #2 OR BOTH. 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. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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 11 MONTHS POST IMPLANT OF VENTRALEX ST, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE AND ADHESIONS THEREBY UNDERWENT REPAIR WITH THE REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS ADHESIONS AS A POSSIBLE COMPLICATION. THIS SUPPLEMENTAL EMDR REPRESENTS THE VENTRALEX ST (DEVICE #1). AN ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE VENTRALEX ST (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.

    Description of Event or Problem · 0

    THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2016: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL INCISIONAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #1), REFERENCE NUMBER (B)(4), LOT NUMBER HUZH0862 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2017: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL INCISIONAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #2), REFERENCE NUMBER (B)(4), LOT NUMBER HUAW0169 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2017: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR 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) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS EXCISED. A VENTRALEX ST (DEVICE #1) WAS PLACED AGAINST THE PERITONEUM AND THE APRON OF THE MESH WAS SECURED WITH SUTURES.¿ (B)(6)2016 - PATIENT WAS DIAGNOSED WITH CHRONIC CHOLECYSTITIS. (B)(6)2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL AND EPIGASTRIC HERNIA THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #2). PER OPERATIVE NOTES, ¿THERE WAS A SMALL DEFECT IN THE PERITONEUM. THE PREPERITONEAL AND OMENTUM WAS RETURNED TO THE ABDOMINAL CAVITY THE DEFECT WAS REPAIRED USING A VENTRALEX ST (DEVICE #2) AND WAS SECURED USING SUTURES.¿ (B)(6)2017 TO (B)(6)2019 - PATIENT VISITED HOSPITAL FOR ABDOMINAL PAIN. (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF MESHES (DEVICE #1 & #2) AND IMPLANT OF VENTRALIGHT ST WITH ECHO POSITIONING SYSTEM (DEVICE #3). PER OPERATIVE NOTES, ¿A LOOP OF SMALL BOWEL WAS STUCK TO THE RIM OF THE DEFECT AND DENSELY ADHERENT TO THE MESH, EXCESS MESH WAS RESECTED. A VENTRALIGHT ST W/ ECHO (DEVICE #3) WAS THEN PLACED INTRA-ABDOMINALLY AND EXPANDED WITH THE BALLOON APPARATUS AND POSITIONED OVER THE DEFECT. THE MESH WAS THEN SECURED TO THE ANTERIOR ABDOMINAL WALL WITH MULTIPLE TACKS.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, PAIN, HERNIA RECURRENCE, INFECTION 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 FAILED AND TO REMOVE THE VENTRALEX ST"; HOWEVER THE DESCRIPTION DOES NOT CLEARLY DEFINE IF THE VENTRALEX ST REMOVED REFERS TO DEVICE #1, DEVICE #2 OR BOTH. 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. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. THIS EMDR REPRESENTS THE BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #1), REFERENCE NUMBER 5950008, LOT NUMBER HUZH0862 IMPLANTED ON (B)(6) 2016. AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #2), REFERENCE NUMBER 5950007, LOT NUMBER HUAW0169 IMPLANTED ON (B)(6) 2017. 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) 2016: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL INCISIONAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #1), REFERENCE NUMBER 5950008, LOT NUMBER HUZH0862 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2017: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL INCISIONAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH (DEVICE #2), REFERENCE NUMBER 5950007, LOT NUMBER HUAW0169 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2017: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR 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
    146097 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUZH0862 00801741031489

    Patients

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