BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 18956587 · Received March 21, 2024

    Report

    Report Number
    2210968-2024-03325
    Event Type
    Injury
    Date Received
    March 21, 2024
    Date of Event
    April 18, 2022
    Report Date
    March 21, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: GRAEFE'S ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY (2022) HTTPS://DOI.ORG/10.1007/S00417-022-05655-0. RELATED EVENTS CAPTURED VIA 2210968-2024-03324, 2210968-2024-03325.

    Description of Event or Problem · 0

    TITLE: IS CANALOPLASTY WITH MITOMYCIN C A SAFE PROCEDURE IN MYOPIC GLAUCOMA? THE AIM OF THIS STUDY IS TO DISPLAY A CONSIDERABLE RISK OF COMPLICATIONS FOLLOWING ANTIGLAUCOMATOUS FILTERING SURGERY, E.G., TRABECULECTOMY. CANALOPLASTY WITH MITOMYCIN C MAY REDUCE THIS RISK BY AVOIDING MASSIVE OVERFILTRATION. THIS IS A RETROSPECTIVE ANALYSIS OF 31 EYES WITH MYOPIA THAT UNDERWENT CANALOPLASTY MODIFIED WITH MITOMYCIN C IN A CONSECUTIVE SINGLE-SURGEON CASE SERIES. ANNUAL DATA AND SUCCESS RATES WERE ANALYZED. TWENTY-THREE MYOPIC EYES THAT HAD RECEIVED CONVENTIONAL TRABECULECTOMY WITH MITOMYCIN C WERE RECORDED AS A COMPARISON. IN THE CP GROUP, 31 EYES OF 26 PATIENTS WITH A MEAN SPHERICAL EQUIVALENT (SE) OF-8.4 WERE INCLUDED. IN THE TE GROUP, 23 EYES OF 16 PATIENTS WITH SE OF - 7.5 WERE INCLUDED. DURING THE PROCEDURE USING IN CP (CANALOPLASTY) WITH MMC TECHNIQUE, THE INCISION OF THE CONJUNCTIVA WAS FOLLOWED BY THE PREPARATION OF A SCLERAL FLAP JUST LIKE IN TE. WHILE IN TE WITH MMC TECHNIQUE, A MICROCATHETER WITH AN ATTACHED PROLENE SUTURE WAS INSERTED INTO SCHLEMM¿S CANAL AND PUSHED FORWARD ALL 360°; THE PROLENE-9 SUTURES WERE THEN REDRAWN THROUGH SC LUMEN. WHILE THE CATHETER WAS WITHDRAWN, VISCOELASTICUM WAS INJECTED TO WIDEN THE CANAL. THE SUTURE ENDS WERE TIED TOGETHER TO CAUSE TENSION OF THE SCHLEMM CANAL¿S INNER WALLS AND THEREBY WIDEN IT. THE SURGEON ADJUSTED THE FLOW OF AQUEOUS UNDER THE SCLERAL FLAP BY ALTERING THE TENSION ON THE 9¿0 NYLON SINGLE-BUTTON FLAP SUTURES. THE FILTERING ZONE WAS SEWED UP WITH CONJUNCTIVAL 8¿0 VICRYL SUTURES. REPORTED COMPLICATION: HYPHEMA(N-?). HEMORRHAGE BENEATH FILTERING ZONE (N-?). CORNEAL OEDEMA (N-?). HYPERTENSION (N- 23). HYPOTONY (N-23). CONCLUSION: THE ARTICLE STATES THAT MODIFIED CP IS A SAFE AND EFFECTIVE SURGICAL PROCEDURE TO LOWER IOP IN MYOPIC AND HIGHLY MYOPIC GLAUCOMA PATIENTS. MEAN EXPECTED IOP LEVELS ARE BETWEEN 12 AND 17 MMHG. IOP REDUCTION AFTER CP WITH MMC IS SLIGHTLY BETTER IN HIGHLY MYOPIC PATIENTS. MEDICATION SCORE REDUCTION< 2 IN A MEAN IS NOT LASTING LONGER THAN 2 YEARS. INCIDENCE OF HYPOTONY IS LOW; SEVERE COMPLICATIONS DUE TO HYPOTONY WITH IMPAIRMENT OF THE POSTERIOR EYE¿S SEGMENT IS EVEN LOWER. RECOVERY OF VISUAL ACUITY AFTER CP IS SLIGHTLY FASTER. DURING YEARS OF FOLLOW-UP REVISION, SURGERY IS OFTEN REQUIRED, BUT SPECTRUM OF SUBSEQUENT SURGERY IS NOT RELEVANTLY NARROWED. TE IN MYOPIC EYES PROVED TO BE A STRONG IOP LOWERING PROCEDURE TO 10¿13 MMHG WITH LOW INCIDENCE OF HYPOTONY IN A LONG-TERM FOLLOW-UP. NEVERTHELESS, HYPOTONIC AND HYPERTONIC CRISES WERE SIGNIFICANTLY HIGHER THAN AFTER CP. THE NEED OF SURGICAL INTERVENTION IN THE EARLY POSTSURGICAL PHASE WAS MOST LIKELY. REVISION SURGERY IN LONG-TERM FOLLOW UP WAS REQUIRED RARELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2559053 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention