BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22184827 · Received June 11, 2025

    Report

    Report Number
    2210968-2025-06614
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    November 26, 2024
    Report Date
    June 11, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: AM J OPHTHALMOL CASE REP. 2024 NOV 26; 36:102223. DOI: 10.1016/J.AJOC.2024.102223. PMID: 39687768; PMCID: PMC11647464. HTTPS://DOI.ORG/10.1016/J.AJOC.2024.102223.

    Description of Event or Problem · 0

    UNBURIED POLYTETRAFLUOROETHYLENE SCLERAL SUTURE EROSIONS AND FAILURE OF PERICARDIAL GRAFT REVISION. THE AIM OF THIS STUDY IS TO REPORT THREE CASES OF EXPOSED, UNBURIED POLYTETRAFLUOROETHYLENE (GORE-TEX) SUTURES USED FOR SCLERAL FIXATED INTRAOCULAR LENSES AND THEIR MANAGEMENT, INCLUDING FAILURE OF PERICARDIAL PATCH AND SUCCESS OF IRRADIATED CORNEAL PATCH. THIS SERIES AIMS TO INFORM MANAGEMENT OPTIONS FOR THIS UNCOMMON ADVERSE EVENT. CASE 1 (75-YEAR-OLD ETHIOPIAN FEMALE) , CASE 2 (54-YEAR-OLD CAUCASIAN FEMALE) AND CASE 3 (66-YEAR-OLD AFRICAN AMERICAN MALE). A PERICARDIAL PATCH GRAFT WAS PLACED ON TOP OF THE ERODED SUTURES AND WAS SECURED USING A COMBINATION OF TISSEEL TISSUE GLUE AND 8-0 VICRYL SUTURES. REPORTED COMPLICATIONS ARE: ONE WEEK POSTOPERATIVELY, THE CONJUNCTIVAL AUTOGRAFT STARTED TO RETRACT, LEAVING A PORTION OF THE PERICARDIAL GRAFT EXPOSED, BUT NOT THE GORE-TEX SUTURES TREATMENT: NOT REPORTED. TWO MONTHS FOLLOWING THE PERICARDIAL GRAFT AND CONJUNCTIVOPLASTY, THE PATIENT PRESENTED TO CLINIC WITH RECURRENT COMPLAINTS OF FOREIGN BODY SENSATION TREATMENT: NOT REPORTED RECURRENT IRITIS. TREATMENT: GIVEN SEVERE THINNING OF THE PATIENT¿S SCLERA ADJACENT TO THE LIMBUS AND CONCERN FOR PERFORATION, SHE UNDERWENT LENS EXPLANTATION. -PATIENT DEVELOPED CHRONIC, STERILE ENDOPHTHALMITIS AND PROGRESSIVE SCLEROMALACIA. IOL WAS EXPLANTED. TREATMENT: NOT REPORTED. IN CONCLUSION, PERICARDIAL PATCH GRAFTING MAY NOT WORK WELL FOR UNBURIED GORE-TEX SUTURE EXPOSURE. EYES WITH PRIOR COMPLEX HISTORIES ARE AT RISK FOR EROSION OF UNBURIED GORE-TEX SUTURES WITH SURGICAL REPAIR REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102307 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention