BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 11972448 · Received June 10, 2021

    Report

    Report Number
    9614546-2021-07202
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 14, 2020
    Report Date
    July 12, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER REVIEW ON JUN 14, 2024, IT WAS NOTED THAT SECTION D4 CATALOG NUMBER WAS SUBMITTED AS BG102-350 ON THE INITIAL MDR, BUT SHOULD BE 23030818. THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT. THE FOLLOWING FIELD HAS BEEN UPDATED ACCORDINGLY: SECTION D4: CATALOG NUMBER: 23030818. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE: SEX/AGE AT BGI SURGERY: M/(B)(6), F/(B)(6), M/(B)(6), M/(B)(6)(RIGHT), M/(B)(6)(LEFT). WEIGHT, ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS (B)(6) 2020. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS THERE IS NO INDICATION THAT THE DEVICE WAS EXPLANTED. PHONE NUMBER: (B)(6). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: KAKIHARA, S., HIRANO, T., IMAI, A., MIYAHARA, T., MURATA, T., BAERVELDT GLAUCOMA DRAINAGE IMPLANT SURGERY FOR SECONDARY GLAUCOMA IN PATIENTS WITH TRANSTHYRETIN-RELATED FAMILIAL AMYLOID POLYNEUROPATHY. JAPANESE JOURNAL OF OPHTHALMOLOGY (2020); 64:PP. 533¿538. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE TITLE: BAERVELDT GLAUCOMA DRAINAGE IMPLANT SURGERY FOR SECONDARY GLAUCOMA IN PATIENTS WITH TRANSTHYRETIN-RELATED FAMILIAL AMYLOID POLYNEUROPATHY A RETROSPECTIVE STUDY WAS DONE TO INVESTIGATE OUTCOMES ASSOCIATED WITH BAERVELDT GLAUCOMA DRAINAGE IMPLANT (BGI) SURGERY FOR REFRACTORY GLAUCOMA SECONDARY TO TRANSTHYRETIN (TTR)-RELATED FAMILIAL AMYLOID POLYNEUROPATHY (FAP) WITH TTR VAL30MET MUTATION. A TOTAL OF 5 EYES OF 4 PATIENTS WITH REFRACTORY GLAUCOMA WERE IMPLANTED WITH BG 102-350 (ABBOTT MEDICAL OPTICS). ONE EYE EXHIBITED INTRAOCULAR PRESSURE (IOP) ELEVATION AND WAS CONSIDERED AS A FAILURE 25 MONTHS AFTER BGI SURGERY (DEFINED AS AN IOP VALUE = 22 MMHG, ON TWO CONSECUTIVE VISITS, WITH OR WITHOUT ANTIGLAUCOMA MEDICATION). THE EYE REQUIRED ADDITIONAL GLAUCOMA SURGERY CYCLOPHOTOCOAGULATION USING THE CYCLO G6¿ MICROPULSE P3 (IRIDEX CORPORATION) TO REDUCE IOP AT 26 MONTHS. IN THE EARLY POSTOPERATIVE PERIOD, TRANSIENT HYPOTONY WAS OBSERVED IN 3 EYES, AND TRANSIENT HIGH IOP WAS OBSERVED IN ONE (1) EYE. NO FURTHER INTERVENTIONS WERE DESCRIBED FOR THESE TRANSIENT EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875191 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG102-350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention