BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 10878227 · Received November 20, 2020

    Report

    Report Number
    2210968-2020-09170
    Event Type
    Injury
    Date Received
    November 20, 2020
    Date of Event
    May 5, 2020
    Report Date
    October 7, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO THE FDA: 12/15/2020. ADDITIONAL INFORMATION: B3. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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 ETHICON PRODUCTS INVOLVED (VICRYL SUTURE, PROLENE SUTURE) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (MACROHYPHEMA REQUIRING ANTERIOR CHAMBER LAVAGE, DESCEMET MEMBRANE TEAR IN PERIPHERAL CORNEA) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE, PROLENE SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS LISTED ABOVE. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: J GLAUCOMA 2020;29:813¿818. DOI: 10.1097/IJG.0000000000001559. NOTE: EVENTS REPORTED VIA MW # 2210968-2020-09171.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: OUTCOMES OF CIRCUMFERENTIAL TRABECULOTOMY AND CONVERTED 180-DEGREE TRADITIONAL TRABECULOTOMY IN PATIENTS WITH NEONATAL-ONSET PRIMARY CONGENITAL GLAUCOMA". AUTHOR: ZEYNEP AKTAS, MD, FEBO, AHMET Y. UCGUL, MD AND HATICE T. ATALAY, MD CITATION: J GLAUCOMA 2020;29:813¿818. DOI: 10.1097/IJG.0000000000001559. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SURGICAL SUCCESS RATE AND APPLICABILITY OF CIRCUMFERENTIAL TRABECULOTOMY (CT) COMPARED WITH CONVERTED TRADITIONAL TRABECULOTOMY (TT) IN PATIENTS WITH NEONATAL ONSET PCG IN TURKEY. BETWEEN JANUARY 2009 AND OCTOBER 2018, 42 EYES OF 42 PATIENTS WITH AVERAGE AGE OF 34.0±6.7 (14 TO 59) UNDERWENT 5/0 PROLENE (ETHICON) SUTURE-ASSISTED CIRCUMFERENTIAL TRABECULOTOMY OR RIGID PROBE-ASSISTED TRADITIONAL TRABECULOTOMY WERE RETROSPECTIVELY ANALYZED. AN 8/0 VICRYL TRACTION SUTURE (ETHICON) WAS USED IN THE SUPERIOR PERIPHERAL CORNEA AND PULLING GLOB INFERIORLY AND BLUNTING 5/0 PROLENE (ETHICON) SUTURE WITH A HAND-HELD CAUTERY THEN INSERTING IT INTO SC. IN SUCH CASES OF INADVERTENT TISSUE DAMAGE AND CREATION OF FALSE PASSAGE (SUPRACHOROIDAL OR SUBRETINAL MISDIRECTION), 5/0 PROLENE SUTURE (ETHICON) WAS PULLED BACK AND TRIED TO BE INSERTED INTO THE OPPOSITE SITE OF SC. IF A FAILURE TO COMPLETE A CT OCCURRED, THEN IT WOULD BE CONVERTED TO TT AS A SALVAGE SURGERY. POSTOPERATIVE COMPLICATION REPORTED INCLUDES MICROHYPHEMA (CT N=17, TT N=25) WHICH RESOLVED IN A FEW DAYS, MACROHYPHEMA (CT N=1, TT N=5) REQUIRING ANTERIOR CHAMBER LAVAGE, DESCEMET MEMBRANE TEAR IN THE PERIPHERAL CORNEA (CT N=1, TT N=1) , LIMITED SUPRACHOROIDAL HEMORRHAGE (TT N=1) AND SEROUS RETINAL DETACHMENT (TT N=1) WHICH RESOLVED WITHIN 1 MONTH. CIRCUMFERENTIAL TRABECULOTOMY SEEMS TO BE A SAFER AND MORE SUCCESSFUL PROCEDURE THAN TRADITIONAL TRABECULOTOMY FOR THE TREATMENT OF NEONATAL-ONSET PCG. UNLIKE THE TRADITIONAL PROCEDURE, THE IOP-LOWERING EFFECT OF CIRCUMFERENTIAL TRABECULOTOMY COULD BE MAINTAINED UP TO ~36 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338274 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention