BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRALEX ST

    MDR report key: 7339225 · Received March 14, 2018

    Report

    Report Number
    1213643-2018-00573
    Event Type
    Death
    Date Received
    March 14, 2018
    Date of Event
    January 20, 2014
    Report Date
    October 28, 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 "DECEDENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE VENTRALEX ST FAILED AND TO REMOVE THE VENTRALEX ST. DECEDENT ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATIONS. DECEDENT WAS INJURED SEVERELY AND PERMANENTLY AND ULTIMATELY DIED ON (B)(6) 2016". THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE, A SAMPLE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO MEDICAL RECORDS, AUTOPSY, OR DEATH CERTIFICATE 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 AND 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 FEW YEARS POST IMPLANT OF VENTRALEX ST MESH, PATIENT WAS DIAGNOSED WITH SMALL BOWEL PERFORATION, PERITONITIS, BACTERIAL INFECTION, ABSCESS, HERNIA RECURRENCE, ADHESIONS THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. PATIENT PASSED AWAY ON (B)(6) 2016. PER AUTOPSY REPORT, IT WAS FOUND THAT THE CAUSE OF DEATH IS "PROBABLE SEPSIS SECONDARY TO SMALL BOWEL PERFORATION WITH PERITONITIS AND COMPLICATIONS OF RECENT VENTRAL HERNIA REPAIR SURGERY." DURING AUTOPSY, PATIENT WAS NOTED TO HAVE PERFORATED SMALL BOWEL BENEATH RECENTLY PLACED ABDOMINAL MESH. LOCALIZED PERITONITIS WITH EXUDATE, MESENTERIC INFLAMMATION WITH FAT NECROSIS, STATUS POST PREVIOUS ABDOMINAL VENTRAL HERNIA REPAIR WITH RESIDUAL MESH AND GENERALIZED ATHEROSCLEROSIS. IT WAS MENTIONED THAT THE MESH WAS PLACED DEEP TO THE PREVIOUS MESH WHICH IS EMBEDDED IN SCAR TISSUE IN THE ABDOMINAL WALL. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS ADHESIONS, BOWEL PERFORATION AND INFECTION AS POSSIBLE COMPLICATIONS. THE WARNINGS SECTION OF THE IFU STATES THAT, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE THE REMOVAL OF THE MESH." A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, A4, B4, B5, B6, B7, D4 (UDI NO), E3, F12, G1, G3, G6, H2, H6, H10, H11 CORRECTED FIELDS: B3 (DATE OF EVENT), H4 (MANUFACTURING DATE). THIS SUPPLEMENTAL EMDR REPRESENTS THE VENTRALEX ST (DEVICE #1). ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE VENTRIO MESH (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) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER 5950009, LOT NUMBER HUVE1648 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE VENTRALEX ST FAILED AND TO REMOVE THE VENTRALEX ST. AS REPORTED, THE DECEDENT PATIENT ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATIONS. (B)(6) 2016: THE PATIENT ULTIMATELY DIED AS A DIRECT AND PROXIMATE RESULT OF SUCH INJURIES. AS ALLEGED, THE DECEDENT PATIENT WAS INJURED SEVERELY AND PERMANENTLY, SUFFERED PHYSICAL PAIN AND ULTIMATELY DEATH DUE TO THE ALLEGED DEFECTIVE VENTRALEX HERNIA ST PATCH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, "THE HERNIA SAC ATTACHED TO THE SMALL INTESTINE WERE TAKEN DOWN AND REDUCED INTO THE PERITONEUM CAVITY. THE DEFECT WAS MEASURED AND A VENTRALEX MESH (DEVICE #1) WAS FIXED WITH BOTH ENDS AWAY FROM THE HERNIA SAC BY SUTURING TO THE FASCIA." (B)(6) -2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA WITH SMALL BOWEL INCARCERATION THEREBY UNDERWENT EXPLORATORY LAPAROSCOPY WITH LYSIS OF ADHESIONS. PER OPERATIVE NOTES, "IDENTIFIED AND REMOVED THE HERNIA SAC, THE INFERIOR BORDER OF THE VENTRALEX MESH (DEVICE #1) AND THE LOWER PART OF THE FASCIA. THERE WERE SIGNIFICANT AMOUNT OF ADHESIONS FROM THE FASCIA WHICH WERE CLEANED AND THE SMALL BOWEL WAS REPAIRED WITH TWO LAYERS OF SUTURES. THERE IS PROBABLY TISSUE COVERING THE MESH ITSELF, SO CHOOSE TO NOT REMOVE IT." (B)(6) 2014 TO (B)(6) 2016 - PATIENT HAD MULTIPLE HOSPITAL VISITS FOR ABDOMINAL WALL WOUND INFECTION, UMBILICAL ABSCESS AND DRAINING SEROSANGUINEOUS FLUID THEREBY PROVIDED ANTIBIOTICS. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH EXCISION OF PREVIOUS MESH (DEVICE #1) AND IMPLANT OF VENTRIO MESH (DEVICE #2). PER OPERATIVE NOTES, "HERNIA SAC WAS COMPLETELY EXCISED, AND PART OF THE SMALL BOWEL ADHERED TO THE UNDERLYING MESH (DEVICE #1) WAS CAREFULLY DISSECTED. THEN, PLACED A VENTRIO MESH (DEVICE #2) WITH THE GORE-TEX SIDE FACING THE BOWEL AND SUTURED. TACKER WAS USED TO TACK THE REST OF THE MESH TO THE FASCIA." PATIENT WAS DISCHARGED ON (B)(6) 2016 WITHOUT ANY COMPLICATIONS. (B)(6) 2016 - PATIENT DIED DUE TO ¿PROBABLE SEPSIS SECONDARY TO SMALL BOWEL PERFORATION WITH PERITONITIS AND COMPLICATIONS OF RECENT VENTRAL HERNIA REPAIR SURGERY¿ AS PER AUTOPSY REPORT. DURING AUTOPSY, PATIENT FOUND TO HAVE PERFORATED SMALL BOWEL BENEATH RECENTLY PLACED ABDOMINAL MESH (DEVICE #2), LOCALIZED PERITONITIS WITH EXUDATE, MESENTERIC INFLAMMATION WITH FAT NECROSIS, STATUS POST PREVIOUS ABDOMINAL VENTRAL HERNIA REPAIR WITH RESIDUAL MESH AND GENERALIZED ATHEROSCLEROSIS. IT WAS MENTIONED THAT THE MESH (DEVICE #2) WAS PLACED DEEP TO THE PREVIOUS MESH (DEVICE #1) WHICH IS EMBEDDED IN SCAR TISSUE IN THE ABDOMINAL WALL. ATTORNEY ALLEGES THAT THE PATIENT HAD DEATH, BOWEL PERFORATION, INFECTION, ADHESIONS, BOWEL OBSTRUCTION, PAIN, HERNIA RECURRENCE 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 MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED BY THE PATIENT¿S ATTORNEY. THE INFORMATION PROVIDED ALLEGES THAT THE "DECEDENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR RECURRENT HERNIA AFTER THE VENTRALEX ST FAILED AND TO REMOVE THE VENTRALEX ST. DECEDENT ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATIONS. DECEDENT WAS INJURED SEVERELY AND PERMANENTLY AND ULTIMATELY DIED ON (B)(6) 2016". THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE, A SAMPLE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO MEDICAL RECORDS, AUTOPSY, OR DEATH CERTIFICATE 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. 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.

    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 AN INCISIONAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER 5950009, LOT NUMBER HUVE1648 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 FAILED AND TO REMOVE THE VENTRALEX ST. AS REPORTED, THE DECEDENT PATIENT ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATIONS. ON (B)(6) 2016: THE PATIENT ULTIMATELY DIED AS A DIRECT AND PROXIMATE RESULT OF SUCH INJURIES. AS ALLEGED, THE DECEDENT PATIENT WAS INJURED SEVERELY AND PERMANENTLY, SUFFERED PHYSICAL PAIN AND ULTIMATELY DEATH DUE TO THE ALLEGED DEFECTIVE VENTRALEX HERNIA ST PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181671 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUVE1648 00801741031496

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Disability| R| D