BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 7118360 · Received December 14, 2017

    Report

    Report Number
    2210968-2017-71788
    Event Type
    Injury
    Date Received
    December 14, 2017
    Report Date
    November 27, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE MERSILENE SUTURE USED IN THIS PROCEDURE THAT LED TO PATIENT COMPLICATIONS? CITATION: SRI OPHTHALMOL 2005;89:64-69. DOI: 10.1136/BJO.2004.045278.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE ¿SURGICAL INDUCTION OF CHORIORETINAL VENOUS ANASTOMOSIS IN ISCHAEMIC CENTRAL RETINAL VEIN OCCLUSION: A NON-RANDOMISED CONTROLLED CLINICAL TRIAL.¿ THE SAFETY AND EFFICACY OF SURGICAL INDUCTION OF CHORIORETINAL VENOUS ANASTOMOSIS IN THE MANAGEMENT OF ISCHAEMIC CENTRAL RETINAL VEIN OCCLUSION (CRVO) WAS EVALUATED. IN A COMPARATIVE CLINICAL TRIAL, IN THE PERIOD OF (B)(6) 2001 TO (B)(6) 2003, PATIENTS WITH ISCHEMIC CRVO (CENTRAL RETINAL VEIN OCCLUSION) WERE INCLUDED, AND THOSE WHO DECLINED SURGERY WERE CONSIDERED AS CONTROLS. THE TWO GROUPS WERE NOT SIGNIFICANTLY DIFFERENT IN THE DISTRIBUTION OF AGE, SEX, HYPERTENSION, DIABETES MELLITUS, AND GLAUCOMA. THE SURGICAL CASES UNDERWENT STANDARD VITRECTOMY WITH INCISIONS INTO THE CHOROIDS ADJACENT TO THE PARTIALLY CUT MAJOR RETINAL VEINS. THE SUBJACENT VEIN WAS PARTIALLY CUT OFF AND SMALL PIECES SUTURE WERE INSERTED IN THE INCISED SITES TO INDUCE CHORIORETINAL VENOUS SHUNT. MILD ENDOLASER WAS APPLIED. FOLLOWING SURGERY, PATIENTS WERE EXAMINED WEEKLY IN THE FIRST MONTH, MONTHLY FOR SIX MONTHS, AND EVERY OTHER MONTH THEREAFTER. CLINICAL SUCCESS IN SHUNT DEVELOPMENT WAS 90%. ALL OF THE SURGICAL PATIENTS DEVELOPED AT LEAST ONE ACTIVE SHUNT AND THE SURGICAL SUCCESS RATE (PATENT/ATTEMPTED) WAS 47%. SURGICAL CASES HAD A SIGNIFICANTLY BETTER VISUAL ACUITY IMPROVEMENT COMPARED WITH CONTROLS WITH 80% OF THEM SHOWING IMPROVEMENT (COMPARED WITH 28% OF THE CONTROLS, P =0.016). THE PATIENT WAS FOLLOWED FOR 6-18 MONTHS (MEAN 10 MONTHS). THE PATIENT UNDERWENT REOPERATION FOR CATARACT. NO OTHER SIGNIFICANT COMPLICATIONS OCCURRED. THE STUDY CONCLUDED THAT SURGICAL INDUCTION OF CHORIORETINAL VENOUS ANASTOMOSIS MAY RESULT IN VISUAL ACUITY IMPROVEMENT AND PREVENT NEOVASCULARISATION IN ISCHEMIC CRVO. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898396 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention