BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22327898 · Received June 25, 2025

    Report

    Report Number
    2210968-2025-07391
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    May 10, 2024
    Report Date
    June 25, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: J GLAUCOMA. 2024 OCT 1;33(10):763-768. HTTPS://DOI.ORG/10.1097/IJG.0000000000002422. EPUB 2024 MAY 10. PMID: 38722198.

    Description of Event or Problem · 0

    TITLE: OUTCOMES OF A SECOND AHMED GLAUCOMA IMPLANT WITH MITOMYCIN-C IN PEDIATRIC GLAUCOMA AFTER INITIAL VALVE FAILURE. THE AIM OF THIS STUDY IS TO REPORT THE OUTCOMES OF AHMED GLAUCOMA VALVE IMPLANTATION (AGV) WITH MITOMYCIN-C (MMC) AFTER FAILURE OF A GLAUCOMA DRAINAGE DEVICES (GDD) IN CHILDREN. BETWEEN 2000 AND 2019, OUT OF 115 PROCEDURES PERFORMED DURING THE STUDY PERIOD, 22 WERE IDENTIFIED IN EYES WITH A HISTORY OF PREVIOUS SHUNT SURGERY AND WERE INCLUDED IN THIS SERIES. ONE PATIENT WITH GLAUCOMA FOLLOWING CATARACT SURGERY HAD SEQUENTIAL SURGERY IN BOTH EYES, SO 22 EYES OF 21 PATIENTS WERE INCLUDED. AN AHMED VALVE MODEL S2 WAS IMPLANTED IN 6 EYES AND AN AHMED VALVE MODEL FP7 IN THE 16 OTHERS. THE PRIMED VALVE WAS THEN SECURED TO THE SCLERA AT LEAST 8 MM FROM THE LIMBUS USING TWO 5/0 POLYESTER SUTURES MOUNTED ON ½ CIRCLE SPATULATED NEEDLES; THE REST OF THE PROCEDURE HAS BEEN DESCRIBED IN THE LITERATURE. WE USED A 2 4 MM PATCH OF DONOR SCLERA TO COVER THE TUBE IN THE AREA BETWEEN THE PLATE AND THE LIMBUS, SUTURED TO SCLERA WITH 8-0 VICRYL SUTURES, TAKING CARE NOT TO DAMAGE THE TUBE. IN CASES AT HIGH RISK OF HYPOTONY OR HIGH RISK OF CHOROIDAL DETACHMENT, SUCH AS STURGE-WEBER SYNDROME, THE TUBE WAS TIED ~2 MM FROM THE VALVE ENTRY WITH AN ABSORBABLE 6-0 VICRYL SUTURE BEFORE INSERTION. REPORTED COMPLICATIONS ARE THE FOLLOWING: FAILURES (N=5; 23%) BECAUSE OF SEVERE COMPLICATION (N=3) OR LOSS OF VISION (N=2) . TREATMENT: NOT REPORTED CHOROIDAL DETACHMENT (N=1; 4.5%) DEVELOPED VERY EARLY ON A PATIENT WITH STURGE-WEBER SYNDROME WHICH PROGRESSED TO NO LIGHT PERCEPTION DESPITE VITRECTOMY AND RADIOTHERAPY. TREATMENT: ENUCLEATED FINAL IOP>21 MM HG (N=4; 18%). TREATMENT: WITHOUT FURTHER GLAUCOMA SURGERY UNKNOWN EVENT (N=1; 4.5%). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD FURTHER GLAUCOMA SURGERY WITH UNKNOWN CAUSE HYPOTENSIVE PHASE (N=4; 18%). TREATMENT: NONE OF THEM REQUIRING INTERVENTION HYPERTENSIVE PHASE (TUBE TIED: 2) (N=6; 27%). TREATMENT: RESOLVED BEFORE THE END OF THE FIRST MONTH EXCEPT FOR THOSE WHOSE TUBE WAS LIGATED. UNKNOWN EVENT (N=5; 23%). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD TUBE TRIMMING WITH UNKNOWN CAUSE UNKNOWN EVENT (N=3; 14%). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD REVISION OF THE VALVE WITH EXCISION OF SCAR TISSUE WITH UNKNOWN CAUSE. UNKNOWN EVENT (N=2; 9%). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD CLOSURE OF CONJUNCTIVAL DEFECT OR TUBE EXPOSURE WITH SCLERAL PATCH OR CONJUNCTIVAL GRAFT WITH UNKNOWN CAUSE. UNKNOWN EVENT (N=1). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD NEEDLING WITH 5-FU WITH UNKNOWN CAUSE POSTOPERATIVE IRIS INCARCERATION IN THE TUBE DUE TO THE EXCISION OF SCAR TISSUE, THEN WITH HYPOTONY (N=1) . TREATMENT: REQUIRING THE TYING OF THE TUBE RETINAL DETACHMENT (N=3; 14%) LEADING TO PHTHISIS IN ONE OF THEM. TREATMENT: NOT REPORTED PERSISTENT CONJUNCTIVAL LEAKAGE DESPITE REPEATED CLOSURE OF CONJUNCTIVAL DEFECTS (N=1) TREATMENT: TRANSITIONED TO ADULT CARE WITH AN ONGOING LEAKAGE. CATARACT (N=1; 4.5%). TREATMENT: UNDERWENT CATARACT EXTRACTION 1.2 YEARS AFTER THE AGV IMPLANTATION CORNEA OR GRAFT OPACIFICATION (N=3; 14%). TREATMENT: 2 EYES UNDERWENT A REPEAT PENETRATING KERATOPLASTY 6 MONTHS AFTER AGV IMPLANTATION. DEVELOPED BAND KERATOPATHY (N=2) TREATMENT: ONE OF WHICH WAS TREATED WITH EDTA CHELATION 8 YEARS AFTER AGV IMPLANTATION UNKNOWN EVENT (N=1). TREATMENT: NOT SPECIFIED BUT THERE WERE PATIENT HAD UNDERWENT STRABISMUS SURGERY 8 YEARS AFTER AGV INSERTION WITH UNKNOWN CAUSE EXPOSURE OF TUBE OR PLATE (N=2; 9%). TREATMENT: NOT REPORTED. IN CONCLUSION, IMPLANTING A SECOND VALVE WITH MITOMYCIN-C (MMC) IS A VALUABLE LONG-TERM OPTION AFTER FAILURE OF A DRAINAGE DEVICE, ALLOWING TO SIGNIFICANTLY DECREASE THE IOP AND THE NUMBER OF MEDICATIONS. THE LONG-TERM PROBABILITY OF RELATIVE SUCCESS OF AGV IMPLANTATION WITH MMC AS A SECONDARY PROCEDURE SEEMS CLOSE TO THE REPORTED RESULTS OF FIRST VALVE IMPLANTATION, ALTHOUGH WITH A HIGH RATE OF SEVERE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588979 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention