BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 16077284 · Received December 30, 2022

    Report

    Report Number
    2210968-2022-10773
    Event Type
    Injury
    Date Received
    December 30, 2022
    Date of Event
    January 1, 2021
    Report Date
    December 30, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4). DEVICE NOT RETURNED. RELATED EVENTS REPORTED VIA 2210968-2022-10782 CITATION: KLIN MONATSBL AUGENHEILKD 2021; 238: 358¿360. HTTPS://DOI.ORG/10.1055/A-1386-5634.

    Description of Event or Problem · 0

    TITLE: COMPLICATIONS AFTER MODIFIED EVISCERATION WITH CLOSURE OF THE ANTERIOR SCLERAL SHELL BY DONOR SCLERAL GRAFT THE AIM OF THIS STUDY WAS TO REPORT LONG-TERM RESULTS OF THIS MODIFIED SURGICAL TECHNIQUE OF PLASTIC EVISCERATION SINCE BOTH OF THEIR PATIENTS DEVELOPED COMPLICATIONS THAT FINALLY LED TO THE REMOVAL OF THE IMPLANTS. IN TWO PATIENTS [59-YEAR-OLD MALE (P1) AND 54-YEAR-OLD FEMALE (P2)], BOTH PRESENTED A PAINFUL BLIND HYPOTONIC AND ATROPHIC EYE WITH COMPLICATING CALCIFIED BAND KERATOPATHY AFTER HAEMORRHAGIC GLAUCOMA IN P1 AND CONGENITAL CATARACT, SECONDARY GLAUCOMA, CYCLITIC MEMBRANE FORMATION, AND PROLIFERATIVE VITREORETINOPATHY IN P2. IN BOTH CASES, THE MAXIMAL POSSIBLE SILICONE SPHERE (CIBIS) WAS IMPLANTED INTO THE SCLERAL SHELL (P1 = 20MM, P2 = 18MM). A POLYESTER SUTURES (MERSILENE 4¿0) WAS USED FOR ANTERIOR CLOSURE OF THE SCLERAL SHELL WITH THE DONOR SCLERAL PATCH, AND POLYGLACTIN SUTURES (VICRYL 5¿0 AND 6¿0) WAS USED FOR 2-LAYER CLOSURE OF THE TENON'S CAPSULE AND CONJUNCTIVA. REPORTED COMPLICATIONS INCLUDE: IN P1 (59-YEAR-OLD MALE), EPISODE OF CONJUNCTIVITIS AND DISCHARGE (N=1). SLIT LAMP EXAMINATION PRESENTED AN ATTENUATED CONJUNCTIVA WITH MULTIPLE LARGE DEFECTS, PARTIALLY WITH LOOSE AND UNINTEGRATED POLYESTER SUTURE MATERIAL WITHIN THESE ATROPHIC AREAS (N=1). THE TENON'S CAPSULE WAS MAINLY ATROPHIC (N=1). THE DONOR SCLERA WAS COMPLETELY ATROPHIC (N=1), AND THE ANTERIOR SURFACE OF THE EXPOSED IMPLANT WAS IN DIRECT CONTACT TO THE CONJUNCTIVA OR UNCOVERED (N=1). BACTERIAL SWAPS WERE NEGATIVE. IN P2 (54-YEAR-OLD FEMALE), EVISCERATION SINCE THE RUNNING POLYESTER SUTURE OF THE DONOR SCLERA WAS EXPOSED AFTER MIGRATION THROUGH THE TENON'S CAPSULE AND CONJUNCTIVA (N=1). AFTER REMOVAL OF THE SUTURE MATERIAL, THE PATIENT PRESENTED 2 MONTHS LATER WITH FURTHER EXTRUDED POLYESTER SUTURES THAT WERE USED TO CLOSE THE RADIAL INCISIONS (N=1). A CENTRAL CONJUNCTIVAL DEFECT AND ATROPHY OF THE DONOR SCLERAL FLAP WAS PRESENT (N=1). DEFECT CLOSURE BY SUTURING TENON'S CAPSULE AND CONJUNCTIVA WAS NOT SUCCESSFUL (N=1). THE IMPLANTED SPHERE WAS EXPLANTED AND SUBSTITUTED AGAINST A 16MM SILICONE IMPLANT. AFTER AN INITIALLY UNEVENTFUL POSTOPERATIVE DEVELOPMENT, THE PATIENT EXPERIENCED TWO EPISODES OF BACTERIAL CONJUNCTIVITIS 3 AND 4 MONTHS AFTER IMPLANT EXCHANGE (N=1). ANOTHER 4 MONTHS LATER (27 MONTHS AFTER EVISCERATION), THE PATIENT PRESENTED AGAIN WITH A DEHISCENCE OF THE CONJUNCTIVA AND TENON'S CAPSULE AND EXPOSURE OF THE IMPLANT, WHICH THEN WAS REMOVED (N=1). BOTH PATIENTS RECEIVED A DERMIS-FAT TRANSPLANTATION 2 MONTHS AFTER REMOVAL OF THE SILICONE SPHERES. SINCE THEN, FOLLOW-UP HAS BEEN UNEVENTFUL AND COSMETICALLY SATISFYING. IN CONCLUSION, ALTHOUGH NO DIRECT EVIDENCE ON THE BIOCOMPATIBILITY OF POLYESTER SUTURES FOR SCLERAL ADAPTATION IS AVAILABLE, SOME OBSERVATIONS IN OTHER FIELDS OF OCULAR SURGERY INDICATE THAT MERSILENE SEEMS TO CAUSE MORE INFLAMMATORY REACTIONS, LESS TOLERANCE BY SURROUNDING TISSUE, AND POORER TISSUE INTEGRATION THAN POLYLACTIC OR NYLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2424265 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention