BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 10795937 · Received November 5, 2020

    Report

    Report Number
    2210968-2020-08741
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    February 2, 2020
    Report Date
    October 13, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: J GLAUCOMA 2020;29:E7¿E10; DOI: 10.1097/IJG.0000000000001417.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE, 'TITLE: EYEWATCH RESCUE OF REFRACTORY HYPOTONY AFTER BAERVELDT DRAINAGE DEVICE IMPLANTATION: DESCRIPTION OF A NEW TECHNIQUE'. AUTHOR: SINA ELAHI MD, GIORGIO E. BRAVETTI MD, KEVIN GILLMANN, MBBS, FEBOPHTH, MARCH, ADAN VILLAMARIN PHD, LÉOPOLD MEEUS MD, NIKOS STERGIOPOULOS PHD, KAWEH MANSOURI MD AND ANDRÉ MERMOUD, MD. CITATION: J GLAUCOMA 2020;29:E7¿E10; DOI: 10.1097/IJG.0000000000001417. THIS STUDY INVOLVES AN 83-YEAR-OLD WHITE MALE SUFFERING FROM LONGSTANDING PSEUDOEXFOLIATIVE GLAUCOMA. THE SUBLUXED IOL WAS REPLACED WITH AN IRIS CLAW LENS AND A BGI WAS IMPLANTED INTO THE AC, WITH A PROLENE 4-0 SUTURE (ETHICON) WITHIN ITS LUMEN. EYEWATCH ADJUNCTION WAS PERFORMED AND WAS POSITIONED WITHIN THE SCLERECTOMY BED AND SECURED IN PLACE USING 2 SINGLE PROLENE 9-0 SUTURES (ETHICON). THE TENON¿S CAPSULE AND CONJUNCTIVA WERE THEN CLOSED OVER THE DRAINAGE SYSTEM USING VICRYL 8-0 RESORBABLE SUTURES (ETHICON). AT 1 WEEK AFTER BGI WAS IMPLANTED, THE PATIENT PRESENTED WITH A SHALLOW ANTERIOR CHAMBER (AC) WITH IOL-ENDOTHELIAL CONTACT (N=1), IOP OF 5 MMHG AND EXTENSIVE 180 DEGREES CHOROIDAL DETACHMENT (N=1). ANTIGLAUCOMA MEDICATIONS WERE STOPPED AND SODIUM HYALURONATE (PROVISC) WAS INJECTED INTO THE AC TO REDUCE OVERFILTRATION. THEN, A 360-DEGREE KISSING CHOROIDAL DETACHMENT(N=1) WAS NOTICED. CHOROIDAL DRAINAGE WAS PERFORMED, AND TOPICAL SCOPOLAMINE WAS INTRODUCED, LEADING TO A GOOD INITIAL IMPROVEMENT WITH IOP. SECOND SODIUM HYALURONATE INJECTION WAS PERFORMED, BUT IOP DROPPED TO 2MMHG AGAIN. AFTER 3 MONTHS OF REFRACTORY HYPOTONY (N=1), A DECISION WAS MADE TO ATTEMPT AN EYEWATCH-RESCUE TO THE BAERVELDT TUBE. ON DAY 1 AFTER SURGERY, SOME CELLS WERE NOTED WITHIN THE AC (AC INFLAMMATION) (N=1). TOPICAL ANTIGLAUCOMA TREATMENT WAS RESUMED TEMPORARILY AND THE EYEWATCH WAS OPENED TO 5/6 USING THE EYEWATCH PEN. AT DAY 4, IOP WAS DOWN TO 3MMHG, ANTIGLAUCOMA TREATMENT WAS STOPPED, AND THE EYEWATCH WAS CLOSED TO 6/6 AGAIN. AT 6-MONTH FOLLOW-UP, PRESENCE OF MILD STROMAL EDEMA (N=1) WAS REPORTED. THIS DEMONSTRATES THAT THE EYEWATCH MAY OFFER AN ANSWER NOT ONLY TO THE IMMEDIATE POSTOPERATIVE HYPOTONIC PHASE OF THE GDD SURGERY BUT ALSO TO THE LATER CYSTIC BLEB HYPERTONIC PHASE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255100 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention