BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 7316964 · Received March 6, 2018

    Report

    Report Number
    1213643-2018-00467
    Event Type
    Injury
    Date Received
    March 6, 2018
    Date of Event
    February 10, 2016
    Report Date
    September 30, 2024
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741016653
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. INFLAMMATION IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. AT THIS TIME, NO CONCLUSION CAN BE MADE AS TO THE DEGREE TO WHICH THE MESH MIGRATION MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME. 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 5 YEARS 10 MONTHS POST IMPLANT OF PERFIX PLUG, PATIENT WAS DIAGNOSED WITH ADHESIONS, FIBROSIS, MESH MIGRATION, NERVE DAMAGE, SCAR TISSUE AND PAIN THEREBY UNDERWENT REMOVAL OF MESH. PER OP NOTES, "THE PLUG IS MIGRATED INTO PERITONEAL CAVITY." THE INSTRUCTIONS-FOR-USE SUPPLIED WITH THE DEVICE LIST ADHESIONS AS A POSSIBLE COMPLICATION. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 0

    IT IS ALLEGED BY THE PATIENT'S ATTORNEY THAT ON (B)(6) 2010, AT AGE 19, THE PATIENT UNDERWENT RING INGUINAL HERNIA REPAIR. AS REPORTED, A BARD/DAVOL SMALL PERFIX PLUG, REFERENCE NUMBER 0112950, LOT NUMBER HURE2383 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. IT IS ALLEGED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT REMOVAL OF THE DEFECTIVE PERFIX PLUG AND ILIOINGUINAL, IOIOHYPOGASTRIC, AND GENITOFEMORAL NEURECTOMY. AS REPORTED, UPON VISUALIZING THE PERFIX PLUG, THE SURGEON NOTES "THIS WAS PARTICULARLY CHALLENGING GIVEN THE FACT THAT THIS MESH PLUG IS MIGRATED INTO WHAT APPEAR TO BE THE ACTUALLY THE PERITONEAL CAVITY, THERE ARE DENSE INFLAMMATORY CHANGES IN THE AREA AND USING COMBINATION OF SHARP DISSECTION AND MINIMAL ELECTROCAUTERY, THE MESH WAS COMPLETELY MOBILIZED OFF WHAT APPEARED TO BE THE CORD STRUCTURES. HOWEVER, THIS WAS PARTICULARLY DIFFICULT TO INTERPRET ANATOMY MOSTLY BECAUSE OF THE CHRONIC INFLAMMATORY CHANGES AND MASS EFFECT OF THIS MESH. THERE MAY HAVE BEEN A VERY SMALL AMOUNT OF VASCULAR SUPPLY THAT WAS STILL RUNNING IN WHAT APPEAR TO BE THE LOCATION OF WHERE THE SPERMATIC CORD SHOULD BE. THE VAS DEFERENS WAS IDENTIFIED AND ALSO CLEARLY HAD BEEN TRANSECTED AT THE TIME." AS REPORTED, THE PATIENT CONTINUES TO SUFFER PAIN AND PERMANENT DISFIGUREMENT. IT IS ALLEGED THAT THE PERFIX PLUG IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED AND CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE PERFIX PLUG WAS INITIALLY IMPLANTED TO TREAT. AS ALLEGED, THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2010: PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS TIED OFF AT THE INTERNAL RING. A PERFIX PLUG WAS PLACED INTO THE INTERNAL RING AND SECURED. AN ONLAY PATCH WAS PLACED FROM THE PUBIC TUBERCLE TO THE CONJOINED TENDON.¿ (B)(6) 2016: PATIENT VISITED HOSPITAL FOR RIGHT GROIN PAIN. (B)(6) 2016: PATIENT WAS DIAGNOSED WITH CHRONIC RIGHT INGUINODYNIA THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH AND ILIOINGUINAL, ILIOHYPOGASTRIC AND GENITOFEMORAL NEURECTOMY. PER OPERATIVE NOTES, ¿MESH WAS DENSELY ADHERENT TO THE POSTERIOR ASPECT OF THE EXTERNAL OBLIQUE APONEUROSIS AND THE PLUG IS MIGRATED INTO PERITONEAL CAVITY. THERE WAS EVIDENCE OF SCAR TISSUE. THE MESH WAS COMPLETELY REMOVED FROM THE ABDOMINAL PART FROM THE RIGHT GROIN. THE FLOOR OF THE INGUINAL CANAL, WHICH HAD TO BE OPENED TO REMOVE THE INTRAPERITONEAL MESH USING SUTURE. IDENTIFIED AND RESECTED ALL THREE NEURAL STRUCTURES IN THE RIGHT GROIN CONSISTENT WITH THE ILIOINGUINAL, ILIOHYPOGASTRIC, AND GENITOFEMORAL NERVES. A SYNTHETIC MESH WAS PLACED.¿ ATTORNEY ALLEGES THAT THE PATIENT HAD ADHESIONS, HERNIA RECURRENCE, LOSS OF TESTICLE, MESH MIGRATION, MESH SHRINKAGE, NERVE DAMAGE, OTHER ORGAN PERFORATION, PAIN & SUFFERING. IT WAS ALSO ALLEGED THAT THE PATIENT HAD TRANSACTION OF VAS DEFERENCE AND SPERMATIC CORD CAUSING INFERTILITY IN THE RIGHT TESTICLE AND ALSO SUFFER FROM CHRONIC GROIN PAIN AS WELL AS EMOTIONAL INJURY FROM LOSS OF FERTILITY DUE TO THE INJURIES SUSTAINED TO HIS SPERMATIC CORDS.

    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. INFLAMMATION IS A KNOWN INHERENT RISK OF HERNIA REPAIR SURGERY AND IS IDENTIFIED IN THE ADVERSE REACTION SECTION OF THE IFU AS A POSSIBLE COMPLICATION. AT THIS TIME, NO CONCLUSION CAN BE MADE AS TO THE DEGREE TO WHICH THE MESH MIGRATION MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME. 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 PATIENTS ATTORNEY THAT ON (B)(6) 2010, AT AGE (B)(6), THE PATIENT UNDERWENT RING INGUINAL HERNIA REPAIR. AS REPORTED, A BARD/DAVOL SMALL PERFIX PLUG, REFERENCE NUMBER 0112950, LOT NUMBER HURE2383 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. IT IS ALLEGED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT REMOVAL OF THE DEFECTIVE PERFIX PLUG AND ILIOINGUINAL, IOIOHYPOGASTRIC, AND GENITOFEMORAL NEURECTOMY. AS REPORTED, UPON VISUALIZING THE PERFIX PLUG, THE SURGEON NOTES "THIS WAS PARTICULARLY CHALLENGING GIVEN THE FACT THAT THIS MESH PLUG IS MIGRATED INTO WHAT APPEAR TO BE THE ACTUALLY THE PERITONEAL CAVITY...THERE ARE DENSE INFLAMMATORY CHANGES IN THE AREA AND USING COMBINATION OF SHARP DISSECTION AND MINIMAL ELECTROCAUTERY, THE MESH WAS COMPLETELY MOBILIZED OFF WHAT APPEARED TO BE THE CORD STRUCTURES. HOWEVER THIS WAS PARTICULARLY DIFFICULT TO INTERPRET ANATOMY MOSTLY BECAUSE OF THE CHRONIC INFLAMMATORY CHANGES AND MASS EFFECT OF THIS MESH...THERE MAY HAVE BEEN A VERY SMALL AMOUNT OF VASCULAR SUPPLY THAT WAS STILL RUNNING IN WHAT APPEAR TO BE THE LOCATION OF WHERE THE SPERMATIC CORD SHOULD BE. THE VAS DEFERENS WAS IDENTIFIED AND ALSO CLEARLY HAD BEEN TRANSECTED AT THE TIME." AS REPORTED, THE PATIENT CONTINUES TO SUFFER PAIN AND PERMANENT DISFIGUREMENT. IT IS ALLEGED THAT THE PERFIX PLUG IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED AND CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE PERFIX PLUG WAS INITIALLY IMPLANTED TO TREAT. AS ALLEGED, THE 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
    159303 PERFIX PLUG SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURE2383 00801741016653

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Disability| R