BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 18245887 · Received December 1, 2023

    Report

    Report Number
    2210968-2023-09363
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    May 3, 2023
    Report Date
    December 1, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: GRAEFE'S ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY (2023) 261:2901¿2915; HTTPS://DOI.ORG/10.1007/S00417-023-06075-4.

    Description of Event or Problem · 0

    TITLE: PRESERFLO ¿ MICROSHUNT VERSUS TRABECULECTOMY: 1-YEAR RESULTS ON EFFICACY AND SAFETY. THE PURPOSE OF THE STUDY IS TO COMPARE THE EFFECTIVENESS AND SAFETY OF STAND-ALONE MITOMYCIN C-AUGMENTED (MMC) PRESERFLO¿ MICROSHUNT IMPLANTATION VERSUS MMC-AUGMENTED TRABECULECTOMY IN PATIENTS WITH PRIMARY OPEN-ANGLE GLAUCOMA AFTER THE FIRST YEAR SINCE JUNE 2019, WHEN THE PRESERFLO¿ MICROSHUNT WAS EASILY AVAILABLE IN EUROPE, 30 PATIENTS (15 MALES, 15 FEMALES, MEAN AGE 68.0 YEARS) WITH PRIMARY OPEN-ANGLE GLAUCOMA WHO UNDERWENT GLAUCOMA FILTERING SURGERY USING THE DEVICE AND HAD A MINIMUM OF A 1-YEAR FOLLOW-UP UP TO DECEMBER 2021 WERE INCLUDED IN THE STUDY. BETWEEN 2016 AND 2019, 30 PATIENTS (14 MALES, 16 FEMALES, MEAN AGE 68.5 YEARS) WHO UNDERWENT MMC-AUGMENTED TRABECULECTOMY WERE ALSO INCLUDED IN THE STUDY. ALL PATIENTS WERE IMPLANTED WITH A COMPETITOR¿S MICROSHUNT (MANUFACTURER: SANTEN INC). AFTER THE IMPLANTATION OF THE MICROSHUNT, A 10¿0 ETHILON SUTURE (ETHICON) WAS USED TO SUTURE THE REPOSITIONED TENON AND THE CONJUNCTIVA TOWARDS THE LIMBUS. IF THE TENON WAS TOO TIGHT TO BE POSITIONED TOWARDS THE LIMBUS IT WAS SUTURED SEPARATELY TO THE SCLERA WITH A COMPETITOR 9¿0 ABSORBABLE SUTURES (MANUFACTURER: CATGUT GMBH). MEANWHILE DURING THE TRABECULECTOMY PROCEDURE, THE SCLERAL FLAP WAS SUTURED WITH 2 AND THE TENON AND CONJUNCTIVA WITH 2¿3 SINGLE-KNOT 10¿0 ETHILON SUTURES (ETHICON). THE SUTURE WAS ALSO SET AT THE LIMBUS TO PREVENT POSTOPERATIVE LEAKAGE. POSTOPERATIVELY, ANTERIOR CHAMBER REFORMATION, BLEB NEEDLING, AND LASER SUTURE LYSIS WERE PERFORMED AS NEEDED. REPORTED COMPLICATIONS INCLUDED SEIDEL POSITIVE LEAKAGE (N=7), AND COMPLICATIONS THAT NEEDED LASER SUTURE LYSIS INTERVENTION (N=17). IN CONCLUSION, BOTH PROCEDURES ARE EQUALLY EFFECTIVE AND SAFE IN LOWERING MDIOP, PEAK IOP AND IOP FLUCTUATIONS IN PATIENTS WITH PRIMARY OPEN-ANGLE GLAUCOMA, 1 YEAR AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429729 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention