BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX ST

    MDR report key: 7245934 · Received February 6, 2018

    Report

    Report Number
    1213643-2018-00208
    Event Type
    Injury
    Date Received
    February 6, 2018
    Date of Event
    February 2, 2016
    Report Date
    July 17, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031472
    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. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. ADDENDUM: H11: THIS SUPPLEMENTAL EMDR IS SUBMITTED TO DOCUMENT ADDITIONAL INFORMATION PROVIDED AND TO CORRECT 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 4 MONTHS POST IMPLANT OF VENTRALEX ST MESH, PATIENT WAS DIAGNOSED WITH HERNIA RECURRENCE, ABDOMINAL PAIN AND MESH MIGRATION THEREBY UNDERWENT ADDITIONAL SURGERY. PER OP NOTES, "VENTRALEX ST MESH WAS ACTUALLY IN PLACE ON THE ANTERIOR FASCIA ABOVE THE MUSCLE BUT HAD PULLED COMPLETELY LOOSE FROM THE UPPER ASPECT CREATING THIS HERNIA.¿ 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 MESH, REFERENCE NUMBER (B)(4), LOT NUMBER HUZF1717 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX ST HERNIA PATCH. ADDENDUM PER MEDICAL RECORDS PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST. PER OPERATIVE NOTES, ¿SMALL DEFECT IN THE ANTERIOR FASCIA WAS NOTED AND THIS WAS SEPARATED FROM SURROUNDING MUSCLE. THE HERNIA SAC WAS RETURNED INTO THE ABDOMEN. A SMALL PIECE OF VENTRALEX ST MESH WAS USED TO REINFORCE THE POSTERIOR FASCIA WHICH HAD BEEN CLOSED WITH THE PERITONEUM. THE ANTERIOR FASCIA WAS THEN CLOSED USING SUTURES.¿ (B)(6) 2016 - PATIENT VISITED HOSPITAL FOR GRADUAL INCREASE IN SIZE OF THE MASS IN UPPER LEFT ABDOMEN ABOVE THE LEVEL OF THE UMBILICUS AT THE SITE OF A PREVIOUS HERNIA REPAIR SURGERY. (B)(6) 2016 - PATIENT VISITED HOSPITAL FOR ABDOMINAL PAIN, ABDOMINAL WALL HERNIA IN THE LEFT LATERAL RECTUS ABDOMINUS REGION SUPERIOR TO THE UMBILICAL LEVEL. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH LEFT PARARECTUS RECURRENT VENTRAL ABDOMINAL WALL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿HERNIA WAS LATERAL TO THE RECTUS MUSCLES IN THE LEFT ABDOMEN AT THE LEVEL OF UMBILICUS. AS THE ANTERIOR FASCIA WAS TRANSVERSED IMMEDIATELY, A LARGE PEDICLE OF OMENTUM WAS FOUND PROTRUDING THROUGH THE HERNIA DEFECT. AS THIS WAS REDUCED AND EXAMINATION SHOWED THAT THE HERNIA TRANSVERSED THE LATERAL ASPECT OF THE RECTUS MUSCULATURE. A PREVIOUS REPAIR APPEARED TO BE INFERIOR TO THIS AND THE VENTRALEX ST MESH WAS ACTUALLY IN PLACE ON THE ANTERIOR FASCIA ABOVE THE MUSCLE BUT HAD PULLED COMPLETELY LOOSE FROM THE UPPER ASPECT CREATING THIS HERNIA. THE MESH WAS INCORPORATED THEREFORE IT WAS LEFT INTACT. THE OMENTUM WAS COMPLETELY FREED AND A BIOLOGICAL MESH WAS PLACED INTO THE RETROMUSCULAR PREPERITONEAL SPACE AND SUTURED.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD PAIN, HERNIA RECURRENCE, SEROMA, CHRONIC ABDOMINAL PAIN, AN UNSIGHTLY BULGE AND EMOTIONAL INJURIES.

    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. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. 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 MESH, REFERENCE NUMBER 5950007, LOT NUMBER HUZF1717 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2016: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND "REMOVE IT." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRALEX ST HERNIA PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87587 VENTRALEX ST SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUZF1717 00801741031472

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Disability| R