BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 18993912 · Received March 28, 2024

    Report

    Report Number
    2210968-2024-03578
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    May 31, 2022
    Report Date
    March 28, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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: HTTPS://DOI.ORG/10.1038/S41433-022-02102-6.

    Description of Event or Problem · 0

    TITLE: NON-PENETRATING DEEP SCLERECTOMY WITH THE SUB FLAP (AHMED¿S) SUTURE: A 12-MONTH COMPARATIVE STUDY. THE OBJECTIVE OF THIS STUDY IS TO ASSESS THE IOP-LOWERING EFFECT OF ADDING A MATTRESS SUTURE (AHMED¿S SUTURE) TO NON-PENETRATING DEEP SCLERECTOMY (NPDS), IN PATIENTS WITH OPEN ANGLE GLAUCOMA OVER A 12-MONTH FOLLOW-UP PERIOD. A TOTAL OF 105 EYES FROM 70 PATIENTS WITH OPEN ANGLE GLAUCOMA WHO WERE NOT CONTROLLED DESPITE BEING ON FULL MEDICAL TREATMENT. THIS IS A RANDOMIZED CONTROLLED STUDY COMPARING 52 EYES WITH A SUB-FLAP AHMED¿S SUTURE MODIFIED NPDS (GROUP A) AND 51 WITH A CONVENTIONAL NPDS (GROUP B). COMPLICATIONS WERE NEGLIGIBLE IN BOTH GROUPS, HOWEVER, COINCIDENTLY DURING THE FOLLOW UP PERIOD 2 EYES IN GROUP A AND 1 IN GROUP B WERE SUBJECTED TO A BLUNT TRAUMA RESULTING IN SCLERAL DEHISCENCE WITH IRIS PROLAPSE, WHICH NEEDED SURGICAL IRIDECTOMY AND REPAIR OF THE SCLERA AND CONJUNCTIVA. THE OTHER SIGNIFICANT RISK FACTOR WAS HIGHER POST-OPERATIVE IOP AT THE FIRST WEEK, WHICH ACCORDING TO REGRESSION ANALYSIS WAS ASSOCIATED WITH HIGHER IOP AT 12 MONTHS FOLLOW UP AND WITH INCREASED POST-OPERATIVE ANTIGLAUCOMA MEDICATIONS. IN THE FIRST GROUP (STANDARD NPDS), A 7/0 VICRYL CORNEAL TRACTION SUTURE WAS PLACED IN THE SUPERIOR CORNEA TO INCREASE EXPOSURE OF THE SUPERIOR CONJUNCTIVA. REPORTED COMPLICATIONS INCLUDED IN GROUP A: BLUNT TRAUMA RESULTING IN SCLERAL DEHISCENCE WITH IRIS PROLAPSE (N=2); IN GROUP B: BLUNT TRAUMA RESULTING IN SCLERAL DEHISCENCE WITH IRIS PROLAPSE (N=1) AND A HIGHER POST-OPERATIVE IOP AT 12 MONTHS (N=?). IN CONCLUSION, THE AHMED¿S SUTURE, A SIMPLE, NOVEL AND ECONOMIC MODIFICATION, MAINTAINS LOWER IOP LEVELS AND HAS A HIGHER SUCCESS RATE OVER CONVENTIONAL DS, AS IT IS 30% MORE EFFECTIVE IN REDUCING THE IOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370181 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention