BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRALIGHT ST W/ ECHO

    MDR report key: 7283704 · Received February 20, 2018

    Report

    Report Number
    1213643-2018-00328
    Event Type
    Death
    Date Received
    February 20, 2018
    Date of Event
    January 16, 2015
    Report Date
    October 4, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031786
    PMA / PMN Number
    K122436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 EXPLORATORY LAPAROTOMY ON (B)(6) 2015 FOR "COLONIC MASS", "WHAT APPEARED TO BE A COMBINATION FO INFLAMMATORY PHLEGMON FROM THE OMENTUM AND THE COLON THAT WAS ADHERED TO THE MESH", "THE MESH APPEARED TO BE FIBROTIC, AND THERE APPEARED TO BE SOME MICROABSCESSES", AND "IT WAS DECIDED BY THE PATIENT'S PHYSICIAN TO REMOVE THE ST BARD MESH". THE MESH WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH AN AGGRESSIVE FORM OF CANCER ON (B)(6) 2015 AND ALLEGEDLY DIED ON (B)(6) 2017 FROM COMPLICATIONS ASSOCIATED WITH THE CANCER. ADHESIONS ARE KNOWN INHERENT RISK OF SURGERY AND ADHESIONS, INFLAMMATION, SEROMA, AND INFECTION ARE LISTED IN THE INSTRUCTIONS-FOR-USE AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE STATES, ¿IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS.¿ NO VALID LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. ADDENDUM: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THERE IS NO CHANGE TO INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 2 YEARS 5 MONTHS POST IMPLANT OF VENTRALIGHT ST W/ ECHO, PATIENT WAS DIAGNOSED WITH BACTERIAL INFECTION, ABSCESS, ADHESIONS, INFLAMMATION, FIBROSIS, SCARRING AND NECROSIS THEREBY UNDERWENT OPEN REPAIR WITH MESH REMOVAL. THE PATIENT'S ATTORNEY ALLEGES THAT THE PATIENT PASSED AWAY ON (B)(6) 2017 BECAUSE OF CARDIORESPIRATORY FAILURE DUE TO METASTATIC ADENOCARCINOMA. NO AUTOPSY REPORT OR DEATH CERTIFICATE HAVE BEEN PROVIDED IN MEDICAL RECORDS. 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 LAPAROSCOPIC VENTRAL HERNIA. A BARD/DAVOL VENTRALIGHT ST WITH ECHO, REFERENCE NUMBER (B)(4), WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2015: THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY FOR COLONIC MASS. UPON ENTERING THE PATIENT'S ABDOMEN, THE PHYSICIAN NOTED "WHAT IT APPEARED TO BE WAS A COMBINATION OF INFLAMMATORY PHLEGMON FROM THE OMENTUM AND THE COLON THAT WAS ADHERED TO THE MESH. THIS WAS TAKEN DOWN USING ALMOST A FINGER FRACTURE METHOD, AS IT APPEARED TO BE COMPLETELY FIRMLY ADHERENT TO THE MESH. I CARRIED THE INCISION ALL THE WAY UP TO THE UPPER MIDLINE JUST BELOW THE XIPHOID, AND EVEN IN THIS AREA, A PORTION OF THE STOMACH APPEARED TO BE ADHERED TO THE MESH." THE PHYSICIAN THEN FOUND "WHAT APPEARED TO BE A MASS-LIKE LESION, WHICH APPEARED TO BE A COMBINATION OF INFLAMMATORY OMENTUM AND COLON THAT WAS FIRMLY ADHERENT TO WHAT APPEARED TO BE THE MESH. I TOOK THIS DOWN USING ALMOST A FINGER FRACTURE METHOD, AS IT WAS COMPLETELY ADHERED TO THE MESH." THE PHYSICIAN THEN WORKED HIS "WAY PROXIMALLY TO THE HEPATIC FLEXURE. AGAIN, THIS WAS TAKEN DOWN USING BLUNT DISSECTION MOSTLY, AS EVERYTHING APPEARED TO BE STUCK AND FIBROTIC. IT WAS DIFFICULT TO SAY WHETHER THE OMENTUM IN THIS AREA, WHICH WAS VERY FIBROTIC, WAS ACTUALLY TUMOR OR JUST A REACTION FROM THE MESH." EVENTUALLY, "THE LARGE BOWEL AND THE SMALL BOWEL WERE DELIVERED FROM THE PATIENT'S ABDOMEN AND THEN SENT DOWN FOR PERMANENT SECTIONING." THE PHYSICIAN THEN ADDRESSED "THE RIGHT UPPER QUADRANT AGAIN. THERE WAS A FAIR AMOUNT OF INFLAMMATORY MASS/OMENTUM IN THIS AREA THAT I FELT NEEDED TO BE REMOVED AS WELL. THIS WAS ALSO FIRMLY ADHERENT TO THE MESH. AGAIN, I WAS NOT SURE IF THIS WAS AN ACTUAL TUMOR, JUST A REACTION TO THE MESH OR BOTH." THE PHYSICIAN DECIDED TO REMOVE THE VENTRALIGHT ST WITH ECHO "BECAUSE THE SOURCE OF HER SYMPTOMS MAY HAVE BEEN AN ISSUED WITH A REACTION TO THE INFECTED MESH." THE PHYSICIAN CONCLUDED BY STATING "AGAIN THE MESH APPEARED TO BE FIBROTIC, AND THERE APPEARED TO BE SOME MICROABSCESES AS I CAME ACROSS THE MESH IN THE RIGHT UPPER QUADRANT. THIS REACTION TO THE MESH, AGAIN, WAS MOST PRONOUNCED AND THE MOST FIBROTIC IN THE RIGHT UPPER QUADRANT." (B)(6) 2015: PATHOLOGY OF THE OMENTUM REVEALED "FIBROSIS, PERITONITIS AND FOREIGN BODY GRANULOMATOUS REACTION, COMPATIBLE WITH REACTION TO MESH. NEGATIVE FOR CARCINOMA. PATHOLOGY FOR THE TRANSVERSE COLON, ILEUM AND PROXIMAL COLON REVEALED "SEROSA WITH FIBROSIS, PERITONITIS AND WITH FOREIGN BODY GRANULOMATOUS REACTION, COMPATIBLE WITH REACTION TO MESH. INCIDENTALLY IDENTIFIED 6 X 3.8CM TUBULOVILLOUS ADENOMA HIGH GRADE DYSPLASIA AND SUPERFICIALLY INVASIVE WELL DIFFERENTIATED ADENOCARCINOMA EXTENDING INTO THE SUBMUCOSAL LAYERS." PATIENT WAS DIAGNOSED WITH AN AGGRESSIVE FORM OF CANCER. (B)(6) 2017: THE PATIENT LEARNED THAT THE CANCER HAD SPREAD. PATIENT WAS DIAGNOSED WITH STAGE 4 PANCREATIC CANCER. (B)(6) 2017 - PATIENT DIED OF CARDIORESPIRATORY FAILURE DUE TO METASTATIC ADENOCARCINOMA. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE "ST BARD MESH", THE PATIENT SUFFERED INJURIES AND DAMAGES. THE "ST BARD MESH" IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED, AND HAS TO BE SURGICALLY REMOVE NECESSITATING FURTHER INVASIVE SURGERY TO REPAIR THE VERY ISSUE THAT THE PRODUCT WAS INTENDED TO REPAIR, AND THUS PROVIDED NO BENEFIT TO HER. PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST W/ ECHO. PER OPERATIVE NOTES, ¿THE DEFECT WAS FOUND IN SUPRAUMBILICAL REGION. A VENTRALIGHT ST W/ECHO PATCH WAS PLACED IN THE CENTER MOST PORTION OF THE DEFECT AND TACKED CIRCUMFERENTIALLY TO SECURE IT TO THE ABDOMINAL WALL.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH COLONIC MASS THEREBY UNDERWENT OPEN REPAIR WITH THE LYSIS OF ADHESIONS, RIGHT HEMICOLECTOMY WITH ILEOCOLONIC ANASTOMOSIS AND EXPLANT OF INFECTED VENTRALIGHT ST W/ ECHO. PER OPERATIVE NOTES, ¿THE MESH WAS JUST ABOVE AND UNDERNEATH THE UMBILICUS WAS INCISED. ADHESIONS WERE TAKEN DOWN. THE UPPER OMENTUM FOUND TO BE VERY SCARRED AND FIBROTIC. IN THE RIGHT UPPER QUADRANT, A MASS-LIKE LESION APPEARED TO BE COMBINATION OF INFLAMMATORY OMENTUM AND COLON ADHERENT TO THE MESH. THE MESH WAS TACKED UP WITH TACKS AND THE MESH APPEARED TO BE FIBROTIC AND MICRO ABSCESSES FOUND IN THE RIGHT UPPER QUADRANT AND THE MESH WAS COMPLETELY REMOVED FROM THE ABDOMEN.¿ (B)(6) 2016 TO (B)(6) 2017 - PATIENT VISITED HOSPITAL AND DIAGNOSED WITH METASTATIC MUCINOUS ADENOCARCINOMA. ALSO, CT NEEDLE BIOPSY PERITONEUM WAS PERFORMED ON (B)(6) 2017. (B)(6) 2017 - PATIENT WAS DIAGNOSED HAVING ABDOMINAL PAIN WITH OPEN WOUND DURING FOLLOW-UP VISIT. ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTION, BOWEL PERFORATION, BOWEL REMOVAL, DEATH, INFECTIONS, MESH MIGRATION, CANCER, 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 EXPLORATORY LAPAROTOMY ON (B)(6) 2015 FOR "COLONIC MASS", "WHAT APPEARED TO BE A COMBINATION FO INFLAMMATORY PHLEGMON FROM THE OMENTUM AND THE COLON THAT WAS ADHERED TO THE MESH", "THE MESH APPEARED TO BE FIBROTIC, AND THERE APPEARED TO BE SOME MICROABSCESSES", AND "IT WAS DECIDED BY THE PATIENT'S PHYSICIAN TO REMOVE THE ST BARD MESH". THE MESH WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH AN AGGRESSIVE FORM OF CANCER ON (B)(6) 2015 AND ALLEGEDLY DIED ON (B)(6) 2017 FROM COMPLICATIONS ASSOCIATED WITH THE CANCER. ADHESIONS ARE KNOWN INHERENT RISK OF SURGERY AND ADHESIONS, INFLAMMATION, SEROMA, AND INFECTION ARE LISTED IN THE INSTRUCTIONS-FOR-USE AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE STATES, ¿IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS.¿ NO VALID LOT NUMBER HAS BEEN PROVIDED; THEREFORE A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE PROVIDED A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: 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 LAPAROSCOPIC VENTRAL HERNIA. A BARD/DAVOL VENTRALIGHT ST WITH ECHO, REFERENCE NUMBER 5955810, WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2015: THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY FOR COLONIC MASS. UPON ENTERING THE PATIENT'S ABDOMEN, THE PHYSICIAN NOTED "WHAT IT APPEARED TO BE WAS A COMBINATION OF INFLAMMATORY PHLEGMON FROM THE OMENTUM AND THE COLON THAT WAS ADHERED TO THE MESH. THIS WAS TAKEN DOWN USING ALMOST A FINGER FRACTURE METHOD, AS IT APPEARED TO BE COMPLETELY FIRMLY ADHERENT TO THE MESH. I CARRIED THE INCISION ALL THE WAY UP TO THE UPPER MIDLINE JUST BELOW THE XIPHOID, AND EVEN IN THIS AREA, A PORTION OF THE STOMACH APPEARED TO BE ADHERED TO THE MESH." THE PHYSICIAN THEN FOUND "WHAT APPEARED TO BE A MASS-LIKE LESION, WHICH APPEARED TO BE A COMBINATION OF INFLAMMATORY OMENTUM AND COLON THAT WAS FIRMLY ADHERENT TO WHAT APPEARED TO BE THE MESH. I TOOK THIS DOWN USING ALMOST A FINGER FRACTURE METHOD, AS IT WAS COMPLETELY ADHERED TO THE MESH." THE PHYSICIAN THEN WORKED HIS "WAY PROXIMALLY TO THE HEPATIC FLEXURE. AGAIN, THIS WAS TAKEN DOWN USING BLUNT DISSECTION MOSTLY, AS EVERYTHING APPEARED TO BE STUCK AND FIBROTIC. IT WAS DIFFICULT TO SAY WHETHER THE OMENTUM IN THIS AREA, WHICH WAS VERY FIBROTIC, WAS ACTUALLY TUMOR OR JUST A REACTION FROM THE MESH." EVENTUALLY, "THE LARGE BOWEL AND THE SMALL BOWEL WERE DELIVERED FROM THE PATIENT'S ABDOMEN AND THEN SENT DOWN FOR PERMANENT SECTIONING." THE PHYSICIAN THEN ADDRESSED "THE RIGHT UPPER QUADRANT AGAIN. THERE WAS A FAIR AMOUNT OF INFLAMMATORY MASS/OMENTUM IN THIS AREA THAT I FELT NEEDED TO BE REMOVED AS WELL. THIS WAS ALSO FIRMLY ADHERENT TO THE MESH. AGAIN, I WAS NOT SURE IF THIS WAS AN ACTUAL TUMOR, JUST A REACTION TO THE MESH OR BOTH." THE PHYSICIAN DECIDED TO REMOVE THE VENTRALIGHT ST WITH ECHO "BECAUSE THE SOURCE OF HER SYMPTOMS MAY HAVE BEEN AN ISSUED WITH A REACTION TO THE INFECTED MESH." THE PHYSICIAN CONCLUDED BY STATING "AGAIN THE MESH APPEARED TO BE FIBROTIC, AND THERE APPEARED TO BE SOME MICROABSCESES AS I CAME ACROSS THE MESH IN THE RIGHT UPPER QUADRANT. THIS REACTION TO THE MESH, AGAIN, WAS MOST PRONOUNCED AND THE MOST FIBROTIC IN THE RIGHT UPPER QUADRANT." ON (B)(6) 2015: PATHOLOGY OF THE OMENTUM REVEALED "FIBROSIS, PERITONITIS AND FOREIGN BODY GRANULOMATOUS REACTION, COMPATIBLE WITH REACTION TO MESH. NEGATIVE FOR CARCINOMA. PATHOLOGY FOR THE TRANSVERSE COLON, ILEUM AND PROXIMAL COLON REVEALED "SEROSA WITH FIBROSIS, PERITONITIS AND WITH FOREIGN BODY GRANULOMATOUS REACTION, COMPATIBLE WITH REACTION TO MESH. INCIDENTALLY IDENTIFIED 6 X 3.8CM TUBULOVILLOUS ADENOMA HIGH GRADE DYSPLASIA AND SUPERFICIALLY INVASIVE WELL DIFFERENTIATED ADENOCARCINOMA EXTENDING INTO THE SUBMUCOSAL LAYERS." PATIENT WAS DIAGNOSED WITH AN AGGRESSIVE FORM OF CANCER. NI/NI/2017: THE PATIENT LEARNED THAT THE CANCER HAD SPREAD. PATIENT WAS DIAGNOSED WITH STAGE 4 PANCREATIC CANCER. ON (B)(6) 2017 - PATIENT DIED OF CARDIORESPIRATORY FAILURE DUE TO METASTATIC ADENOCARCINOMA. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE "ST BARD MESH", THE PATIENT SUFFERED INJURIES AND DAMAGES. THE "ST BARD MESH" IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED, AND HAS TO BE SURGICALLY REMOVE NECESSITATING FURTHER INVASIVE SURGERY TO REPAIR THE VERY ISSUE THAT THE PRODUCT WAS INTENDED TO REPAIR, AND THUS PROVIDED NO BENEFIT TO HER. PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127166 VENTRALIGHT ST W/ ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI 00801741031786

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Life Threatening| S| R| D