BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 9842025 · Received March 17, 2020

    Report

    Report Number
    2210968-2020-02142
    Event Type
    Injury
    Date Received
    March 17, 2020
    Report Date
    February 21, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    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. 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 (MERSILENE SUTURE, VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (MERSILENE SUTURE, VICRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. CITATION: CLINICAL OPHTHALMOLOGY 2019:13 287¿293. NOTE: EVENTS REPORTED VIA MW 2210968-2020-02143. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: WIDE-ANGLED ENDOILLUMINATION VS TRADITIONAL SCLERAL BUCKLING SURGERY FOR RETINAL DETACHMENT ¿ A COMPARATIVE STUDY". AUTHORS : EYAL COHEN , AMIR ROSENBLATT , SANDY BORNSTEIN, ANAT LOEWENSTEIN ADIEL BARAK , SHULAMIT SCHWARTZ. CITATION: CLINICAL OPHTHALMOLOGY 2019:13 287¿293. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SURGICAL OUTCOMES OF TRADITIONAL SCLERAL BUCKLING (TSB) COMPARED TO CHANDELIER-ASSISTED SCLERAL BUCKLING (CSB) FOR RHEGMATOGENOUS RETINAL DETACHMENT (RRD) REPAIR. BETWEEN JANUARY 2011 AND NOVEMBER 2015, 53 PATIENTS UNDERWENT A SCLERAL BUCKLING (SB) PROCEDURE FOR RRD. OF THE 53, 49 EYES OF 47 PATIENTS WERE INCLUDED IN THE STUDY. TWENTY SEVEN EYES (FEMALE=17; AGE 47.56 ± 16.47 YEARS) UNDER TSB GROUP AND 22 EYES GROUP (FEMALE=10; MEAN AGE 35.73 ± 15.34 YEARS) IN CSB. DURING THE PROCEDURE IN TSB, SEGMENTAL OR CIRCUMFERENTIAL ENCIRCLING BUCKLE CONSISTING OF A SILICONE TIRE OR SPONGE WAS SUTURED TO THE SCLERA WITH 5¿0 MERSILENE MATTRESS SUTURES (ETHICON). THE BUCKLE SUTURES WERE CLOSED AFTER A FINAL ASSESSMENT OF THE BUCKLE HEIGHT AND APPOSITION OF THE RETINAL BREAKS. THE CONJUNCTIVA WAS THEN CLOSED WITH 7¿0 VICRYL SUTURES. REPORTED COMPLICATIONS IN TSB GROUP INCLUDED FAILURE TO ATTACH (N=4) IN WHICH 3 EYES UNDERWENT PARS PLANA VITRECTOMY (PPV) WITH SUCCESSFUL REATTACHMENT AFTER ONE SURGERY AND ONE EYE UNDERWENT A SUPPLEMENTAL INTRAVITREAL GAS INJECTION THAT WAS SUFFICIENT FOR RETINAL REATTACHMENT; CATARACT PROGRESSION (N=2) IN WHICH THE PATIENTS HAD CATARACT REMOVED EITHER AT THE OPERATION ITSELF OR LATER ON A SEPARATE SURGERY FOR FURTHER VISUAL IMPROVEMENT. IN CONCLUSION, CSB IS A MODIFIED TECHNIQUE WITH AN ADVANTAGE OF SUPERIOR VISUALIZATION COMPARED WITH THE TRADITIONAL SURGERY, WHICH SIMPLIFIES THE OPERATION, ENHANCE COMPETENCY, AND COULD BE USED AS A VALUABLE EDUCATIONAL TOOL. IT CAN PROVIDE SIMILAR ANATOMICAL AND FUNCTIONAL OUTCOMES WITH NO ADDITIONAL PERIOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307023 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention