BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7318756 · Received March 6, 2018

    Report

    Report Number
    1213643-2018-00478
    Event Type
    Injury
    Date Received
    March 6, 2018
    Date of Event
    September 16, 2016
    Report Date
    November 6, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031496
    PMA / PMN Number
    K101928
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, LIMITED INFORMATION HAS BEEN PROVIDED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. ADHESIONS ARE A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. NO SPECIFIC DEVICE FAILURE HAS BEEN REPORTED NOR HAVE MEDICAL RECORDS BEEN PROVIDED BY THE PATIENTS ATTORNEY. 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 4 YEARS 6 MONTHS POST IMPLANT OF VENTRALEX ST MESH, PATIENT WAS DIAGNOSED WITH EROSION, OBSTRUCTION, ADHESIONS, ABDOMINAL PAIN AND SCAR TISSUE THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH. THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LISTS EROSION AND PAIN AS POSSIBLE COMPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. UPDATED FIELDS. (UDI NO), 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

    IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT ON (B)(6) 2012 THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCARCERATED VENTRAL HERNIA. AS REPORTED, A VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER 5950009 AND LOT NUMBER HUVL1431 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON (B)(6)2016 THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REMOVE THE VENTRALEX ST, WHICH ADHERED TO THE BOWEL AND PERFORM A REVISION OF THE ABD WALL AND SUBSEQUENTLY ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATION." AS REPORTED BY THE ATTORNEY, THE VENTRALEX ST HERNIA PATCH 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 ALLEGED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX ST MESH. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC HERNIA REPAIR WITH THE IMPLANT OF VENTRALEX ST. PER OPERATIVE NOTES, ¿SOME LOOPS OF BOWEL WERE GENTLY ADHERENT TO THE UNDERSURFACE OF THE ANTERIOR ABDOMINAL WALL, THESE WERE EASILY SWEPT DOWN. THE BOWEL WAS REDUCED OUT OF HERNIA. A CIRCULAR VENTRALEX ST WAS INTRODUCED INTO THE ABDOMINAL CAVITY. THE MESH WAS CIRCUMFERENTIALLY FIXED USING SORBAFIX TACKER.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH PERFORATED MARGINAL ULCER THEREBY UNDERWENT LAPAROSCOPIC REPAIR AND ABDOMINAL WASHOUT. ON (B)(6) 2014 - PATIENT VISITED HOSPITAL FOR SMALL BOWEL OBSTRUCTION. ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, ¿DISTAL COLLAPSED BOWEL WAS NOTED. THERE WERE ADHESIONS TO THE JEJUNOJEJUNOSTOMY CAUSING OBSTRUCTION. AN AREA OF SMALL BOWEL WAS DENSELY ADHERENT TO THE ANTERIOR ABDOMINAL WALL AT THE LOCATION OF MESH (VENTRALEX ST). THE SMALL BOWEL INCORPORATED WITH THE MESH WAS TAKEN DOWN. AN END-TO-END ANASTOMOSIS WAS PERFORMED.¿. ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN. 1ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH CHRONIC POST OPERATIVE PERIUMBILICAL ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF MESH. PER OPERATIVE NOTES, ¿THE MESH (VENTRALEX ST) WAS ENCOUNTERED AND WAS EXCISED ALONG THE SCAR. LYSIS OF ADHESIONS WAS PERFORMED. THE BOWEL WAS GROWN INTO THE MESH AND THE BOWEL WAS RESECTED.¿ ATTORNEY ALLEGED THAT THE PATIENT HAD ADHESIONS, BOWEL OBSTRUCTION, BOWEL PERFORATION, BOWEL REMOVAL, PAIN AND EMOTIONAL INJURIES.

    Additional Manufacturer Narrative · 1

    TO DATE, LIMITED INFORMATION HAS BEEN PROVIDED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. ADHESIONS ARE A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. NO SPECIFIC DEVICE FAILURE HAS BEEN REPORTED NOR HAVE MEDICAL RECORDS BEEN PROVIDED BY THE PATIENTS ATTORNEY. IF ADDITIONAL INFORMATION IS OBTAINED, A SUPPLEMENTAL MDR 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

    IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT ON (B)(6) 2012 THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCARCERATED VENTRAL HERNIA. AS REPORTED, A VENTRALEX ST HERNIA PATCH MESH, REFERENCE NUMBER 5950009 AND LOT NUMBER HUVL1431 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. IT IS ALLEGED THAT ON (B)(6) 2016 THE PATIENT UNDERWENT AN "ADDITIONAL SURGERY TO REMOVE THE VENTRALEX ST, WHICH ADHERED TO THE BOWEL AND PERFORM A REVISION OF THE ABD WALL AND SUBSEQUENTLY ENDURED ADDITIONAL SURGERIES TO TREAT MESH-RELATED COMPLICATION." AS REPORTED BY THE ATTORNEY, THE VENTRALEX ST HERNIA PATCH 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 ALLEGED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX ST MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160763 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUVL1431 00801741031496

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Disability| R