BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRIO ST

    MDR report key: 7229326 · Received January 30, 2018

    Report

    Report Number
    1213643-2018-00163
    Event Type
    Injury
    Date Received
    January 30, 2018
    Date of Event
    May 22, 2013
    Report Date
    June 24, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031519
    PMA / PMN Number
    K101920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE VENTRIO ST (DEVICE #2) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. TO DATE NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT "UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE HERNIA MESH, LYSIS OF ADHESIONS AND REPAIR A RECURRENT INCISIONAL HERNIA." THE DESCRIPTION DOES NOT CLEARLY DEFINE WHICH OF THE MESH, THE VENTRALEX ST, VENTRIO ST, OR BOTH WERE REMOVED. MEDICAL RECORDS WERE NOT PROVIDED. RECURRENCE AND ADHESIONS ARE KNOWN INHERENT RISKS OF SURGERY AND ARE IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS POSSIBLE COMPLICATIONS. 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 1 YEAR 1 MONTH POST IMPLANT OF VENTRIO ST, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ADHESIONS, MESH SHRINKAGE THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. PER OP NOTES, ¿FREED ALL THE ADHESIONS OF THE TRANSVERSE COLON, STOMACH, OMENTUM AND LIVER FROM THIS MESH THAT HAD CURLED INTO THE HERNIA SAC". A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS: A2, B4, B5, B7, E3, G1, G3, G6, H2, H6, H10. THIS SUPPLEMENTAL EMDR REPRESENTS THE VENTRIO ST (DEVICE #2). ADDITIONAL SUPPLEMENTAL EMDR WAS SUBMITTED TO REPRESENT THE VENTRALEX ST (DEVICE #1) 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. H3 OTHER TEXT: NOT RETURNED.

    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 AND UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX ST (DEVICE #1), REFERENCE NUMBER 5950008 AND LOT NUMBER HUVL1452 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ADDITIONALLY, A BARD/DAVOL VENTRIO ST (DEVICE #2) REFERENCE NUMBER 5950020 AND LOT NUMBER HUWB1438 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2013: THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REMOVE THE HERNIA MESH, LYSIS OF ADHESIONS AND REPAIR A RECURRENT INCISIONAL HERNIA." AS REPORTED BY THE ATTORNEY, THE "MESH PRODUCTS" USED IN THE PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN MUCH PAIN AND SUFFERING, DOCTOR VISITS, SUBSEQUENT PROCEDURES AND WAS INJURED SEVERELY AND PERMANENTLY. AS REPORTED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE "MESH PRODUCTS." ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #2) AND OPEN UMBILICAL HERNIA REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿ENCOUNTERED INCARCERATED OMENTUM THROUGH AN UMBILICAL HERNIA, REDUCED THAT COMPLETELY AND DISSECTED BACK TO GOOD FASCIA. LAPAROSCOPE WAS PLACED AND HERNIA WAS IDENTIFIED. THEN, TOOK THE FALCIFORM LIGAMENT DOWN AND REDUCED THE FAT OUT OF THE HERNIA. A VENTRIO ST MESH (DEVICE #2) WAS PLACED INSIDE THE PERITONEAL CAVITY AND SECURED WITH SORBAFIX TACKER. THEN, A VENTRALEX ST MESH (DEVICE #1) WAS PLACED INSIDE THE PERITONEAL CAVITY USING SUTURE AND THIS COVERED THE UMBILICAL HERNIA DEFECT.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF VENTRIO ST MESH (DEVICE #2) AND IMPLANT OF VENTRIO ST MESH (DEVICE #3). PER OPERATIVE NOTES, ¿ENCOUNTERED ADHESIONS BETWEEN THE UMBILICAL MESH AND THE RIGHT UPPER QUADRANT MESH AND FREED ALL THE ADHESIONS OF THE TRANSVERSE COLON, STOMACH, OMENTUM AND LIVER FROM THIS MESH THAT HAD CURLED INTO THE HERNIA SAC. THE MESH WAS COMPLETELY EXCISED IN THE RIGHT UPPER QUADRANT (DEVICE #2). THE UMBILICAL MESH HAD GOOD INGROWTH BUT INFERIORLY IT LOOKED LIKE MESH DIDN¿T COVER THE DEFECT, THERE WAS RECURRENCE BELOW THE MESH AND LEFT THE UMBILICAL HERNIA MESH (DEVICE #1) IN PLACE. A VENTRIO ST MESH (DEVICE #3) WAS PLACED INSIDE THE PERITONEAL CAVITY AND THEN PLACED USING SUTURES.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, MESH MIGRATION, PAIN, HERNIA RECURRENCE, REMOVAL SURGERY AND EMOTIONAL INJURIES.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE VENTRIO ST (DEVICE #2) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. TO DATE NO MEDICAL RECORDS HAVE BEEN PROVIDED. THE INFORMATION PROVIDED ALLEGES THAT THE PATIENT "UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE HERNIA MESH, LYSIS OF ADHESIONS AND REPAIR A RECURRENT INCISIONAL HERNIA." THE DESCRIPTION DOES NOT CLEARLY DEFINE WHICH OF THE MESH, THE VENTRALEX ST, VENTRIO ST, OR BOTH WERE REMOVED. MEDICAL RECORDS WERE NOT PROVIDED. RECURRENCE AND ADHESIONS ARE KNOWN INHERENT RISKS OF SURGERY AND ARE IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE AS POSSIBLE COMPLICATIONS. THIS EMDR REPRESENTS THE BARD VENTRIO ST (DEVICE #2). AN ADDITIONAL EMDR WAS SUBMITTED TO REPRESENT THE BARD VENTRALEX ST (DEVICE#1). 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 AN INCISIONAL AND UMBILICAL HERNIA. A BARD/DAVOL VENTRALEX ST (DEVICE #1), REFERENCE NUMBER 5950008 AND LOT NUMBER HUVL1452 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ADDITIONALLY, A BARD/DAVOL VENTRIO ST (DEVICE #2) REFERENCE NUMBER 5950020 AND LOT NUMBER HUWB1438 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2013: THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REMOVE THE HERNIA MESH, LYSIS OF ADHESIONS AND REPAIR A RECURRENT INCISIONAL HERNIA." AS REPORTED BY THE ATTORNEY, THE "MESH PRODUCTS" USED IN THE PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN MUCH PAIN AND SUFFERING, DOCTOR VISITS, SUBSEQUENT PROCEDURES AND WAS INJURED SEVERELY AND PERMANENTLY. AS REPORTED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE "MESH PRODUCTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70758 VENTRIO ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUWB1438 00801741031519

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Disability| R