BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19097568 · Received April 12, 2024

    Report

    Report Number
    2210968-2024-04237
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    September 17, 2022
    Report Date
    April 12, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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. CITATION: J GLAUCOMA 2023. HTTPS://DOI.ORG/10.1097/IJG.0000000000002129.

    Description of Event or Problem · 0

    TITLE: TWO YEAR RANDOMIZED PROSPECTIVE COMPARISON OF AHMED VALVE VERSUS BAERVELDT IMPLANT IN VITRECTOMIZED EYES. THE AIM OF THIS STUDY IS TO INVESTIGATE AND COMPARE THE EFFICACY AND COMPLICATIONS BETWEEN AHMED FP7 GLAUCOMA VALVE (AGV) AND BAERVELDT 101¿350 GLAUCOMA IMPLANT (BGI) IN VITRECTOMIZED EYES. IN THIS SINGLE-CENTER RANDOMIZED CLINICAL TRIAL, 43 VITRECTOMIZED EYES (39 PATIENTS) UNDERWENT GLAUCOMA DRAINAGE DEVICE IMPLANTATION. EYES WERE RANDOMIZED TO RECEIVE EITHER AN AGV (FP7) OR A BGI (101¿350) AND WERE FOLLOWED FOR 2 YEARS. A TOTAL OF 39 PATIENTS (43 EYES) MET THE INCLUSION CRTERIA AND WERE ENROLLED IN OUR STUDY BETWEEN JANUARY 2016 AND AUGUST 2018. OF THESE, 22 EYES WERE RANDOMIZED TO RECEIVE THE AGV, WHILE 21 EYES RECEIVED THE BGI. DURING THE PROCEDURE, ALL PATIENTS UNDERWENT SUBTENON¿S ANESTHESIA BY INJECTION IN THE SUPEROTEMPORAL AREA. THEN, A 7-0 SILK CORNEAL TRACTION SUTURE WAS PLACED FOR GLOBE FIXATION, AND A FORNIX-BASED CONJUNCTIVAL DISSECTION IN THE SUPEROTEMPORAL QUADRANT EXTENDING AT LEAST 4 CLOCK HOURS WAS ACHIEVED WITH WESTCOTT SCISSORS, ALTHOUGH CAUTERY WAS USED TO ACHIEVE HEMOSTASIS. AT THE END OF ALL SURGERIES, WATERTIGHT CONJUNCTIVAL CLOSURE WAS ACHIEVED WITH 7-0 VICRYL SUTURES. IN AHMED VALVE (MODEL FP7) IMPLANTATION TECHNIQUE, THE PLATE WAS SUTURED TO THE SCLERA 6¿8 MM POSTERIOR TO THE LIMBUS USING TWO 9¿0 NYLON SUTURES. A CORNEOSCLERAL GRAFT PLACED OVER THE TUBE INSERTION WAS SECURED WITH 9¿0 NYLON SUTURES. WHILE IN BAERVELDT (MODEL 101¿350) IMPLANTATION TECHNIQUE, THE PLATE WAS SUTURED TO THE SCLERA 8¿10 MM POSTERIOR TO THE LIMBUS USING TWO 9¿0 NYLON SUTURES. A 7¿0 VICRYL SUTURE WAS USED AROUND THE TUBE TO COMPLETELY OCCLUDE IT, AND BSS WAS INJECTED TO VERIFY WATERTIGHT OCCLUSION. A CORNEOSCLERAL GRAFT PLACED OVER THE TUBE INSERTION WAS SECURED WITH 9¿0 NYLON SUTURES. FINALLY, WATERTIGHT CONJUNCTIVAL CLOSURE WAS ACHIEVED WITH 7¿0 VICRYL SUTURES. REPORTED COMPLICATION: PROLONGED HYPHEMA (N-?). CORNEAL EDEMA (N-?). MOTILITY DISORDER/DIPLOPIA (N-?). SHALLOW AC (N-?). CHOROIDAL DETACHMENT (N-?). PROLONGED IRITIS (N-?). SUPRACHOROIDAL HEMORRHAGE (N-?). CONCLUSIONS: GDDS PROVIDE A VIABLE SOLUTION FOR IOP CONTROL IN VITRECTOMIZED EYES. BASED ON OUR PROSPECTIVE COMPARISON, BOTH AHMED FP7 GLAUCOMA VALVE AND BAERVELDT 101¿350 GLAUCOMA IMPLANT ARE EFFICACIOUS OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413143 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention