BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7180008 · Received January 10, 2018

    Report

    Report Number
    1213643-2018-00052
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    September 29, 2015
    Report Date
    February 5, 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

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE 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 REPAIR THE HERNIA DEFECT AND REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, HOWEVER, 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. NO 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 AVAILABLE INFORMATION, THERE IS NO CHANGE TO THE INITIAL DETERMINATION, NO CONCLUSIONS CAN BE MADE. PER MEDICAL RECORDS REVIEW, ABOUT 4 MONTHS POST IMPLANT OF VENTRALEX ST MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE AND INFLAMMATION THEREBY UNDERWENT REPAIR WITH MESH REMOVAL. PER OPERATIVE NOTES, "THE PREVIOUSLY PLACED MESH WAS SEEN EXTRUDING INTO THE WOUND." THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE IDENTIFY INFLAMMATION AS A POSSIBLE COMPLICATION. 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) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH, REFERENCE NUMBER (B)(4), WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2015: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO "REPAIR THE HERNIA DEFECT AND REMOVE IT." 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 REPORTED, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX ST MESH. ADDENDUM PER MEDICAL RECORDS: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST. PER OPERATIVE NOTES, "THE HERNIA SAC WAS DISSECTED OFF THE SUBCUTANEOUS TISSUES CIRCUMFERENTIALLY DOWN TO THE FASCIAL DEFECT AND THE SAC WAS COMPLETELY REDUCED. A VENTRALEX ST PATCH WAS THEN PLACED INTO THE PREPERITONEAL SPACE AND SUTURED TO THE FASCIAL DEFECT.¿ (B)(6) 2015 - PATIENT HAD BULGE LATERAL TO THE LEFT SIDE OF THE INCISION AND WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF THE MESH AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, "RECURRENT INCISIONAL HERNIA SAC WAS IDENTIFIED AND DISSECTED OUT. THE PREVIOUSLY PLACED MESH WAS SEEN EXTRUDING INTO THE WOUND AND DEBRIDED OFF SHARPLY. A SYNTHETIC MESH WAS PLACED INTO THE PREPERITONEAL SPACE AND SUTURED.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD HERNIA RECURRENCE AND PAIN. IT IS ALSO ALLEGED THAT THE PREVIOUSLY PLACED MESH WAS SEEN EXTRUDING INTO THE WOUND.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN TO WHAT EXTENT THE DEVICE 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 REPAIR THE HERNIA DEFECT AND REMOVE IT." MEDICAL RECORDS WERE NOT PROVIDED AND THE DESCRIPTION DOES NOT CLEARLY DEFINE WHAT "REMOVE IT" IS REFERRING TO (EXAMPLE POSSIBLE MESH EXPLANT, PARTIAL EXPLANT, OR REMOVAL/REPAIR OF THE HERNIA DEFECT ITSELF WITHOUT EXPLANT OF PREVIOUSLY PLACED MESH). AS SUCH AT THIS TIME, WE HAVE NOT IDENTIFIED THIS AS REPORTED DEVICE EXPLANT. IT IS UNCLEAR AT THIS TIME IF THE HERNIA DEFECT REPAIRED POST IMPLANT OF THE MESH WAS A RECURRENCE OF THE ORIGINAL HERNIA DEFECT OR A NEW HERNIA DEFECT, HOWEVER, 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. NO 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. 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) 2015: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL VENTRALEX ST HERNIA PATCH, REFERENCE NUMBER 5950009, WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2015: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO "REPAIR THE HERNIA DEFECT AND REMOVE IT." 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 REPORTED, 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
    23571 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI 00801741031496

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Disability| R