BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 17232635 · Received June 29, 2023

    Report

    Report Number
    3012236936-2023-01587
    Event Type
    Injury
    Date Received
    June 29, 2023
    Report Date
    July 12, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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 MODEL NUMBER WAS SUBMITTED AS 101-350 ON THE INITIAL MDR, BUT SHOULD BE UNKNOWN. THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT. THE FOLLOWING FIELD HAS BEEN UPDATED ACCORDINGLY: SECTION D4: MODEL NUMBER: UNKNOWN ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE 66.60 ± 10.04. SECTION A3: 22 FEMALE, 17 MALE (39 TOTAL). SECTIONS A4, A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS (B)(6) 2022. THE STUDY WAS CONDUCTED FOR SURGERIES PERFORMED BETWEEN (B)(6) 2016 TO (B)(6) 2018. SECTION D4: CATALOG NUMBER: CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN/ NOT PROVIDED SECTION D6B - EXPLANT DATE: N/A, DEVICE REMAINS IMPLANTED. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H6 -HEALTH EFFECT - CLINICAL CODE 4581: SHALLOWING OR COLLAPSING OF THE ANTERIOR CHAMBER. SECTION H6 -HEALTH EFFECT - MEDICAL DEVICE PROBLEM CODE: 3191: TUBE RELATED COMPLICATIONS CITATION: KANDARAKIS, S.A.; PETROU, P.; KATSIMPRIS, A.; PAPAKONSTANTINOU, E.; TIMPILIS, M.; CHRONOPOULOU, K.; LEHMAN, A.; IFANTIDES, C.; GEORGALAS, I.; TWO YEAR RANDOMIZED PROSPECTIVE COMPARISON OF AHMED VALVE VERSUS BAERVELDT IMPLANT IN VITRECTOMIZED EYES; (B)(6) 2023; DOI: 10.1097/IJG.0000000000002129. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: TWO YEAR RANDOMIZED PROSPECTIVE COMPARISON OF AHMED VALVE VERSUS BAERVELDT IMPLANT IN VITRECTOMIZED EYES. A PROSPECTIVE RANDOMIZED CONTROLLED CLINICAL STUDY WAS DONE TO INVESTIGATE AND COMPARE THE EFFICACY AND COMPLICATIONS BETWEEN AHMED FP7 GLAUCOMA VALVE (AGV) AND BAERVELDT 101¿350 GLAUCOMA IMPLANT (BGI) IN VITRECTOMIZED EYES. A TOTAL OF 39 PATIENTS (N=43 EYES) WERE ENROLLED AND RANDOMIZED TO RECEIVE THE AGV (N=22) AND THE BGI (N=21 EYES). THE AGV IMPLANTATION INVOLVED PRIMING WITH BALANCED SALT SOLUTION WITH A 30-GAUGE CANNULA THROUGH THE TUBE; PLATE SUTURED USING TWO 9¿0 NYLON SUTURES; AND CORNEOSCLERAL GRAFT WAS SECURED WITH 9¿0 NYLON SUTURES. THE BGI IMPLANTATION INVOLVED PLATE SUTURED USING TWO 9¿0 NYLON SUTURES; 7¿0 VICRYL SUTURE WAS USED TO COMPLETELY OCCLUDE THE TUBE; NEEDLE FENESTRATIONS WERE DONE USING A 30-GAUGE NEEDLE TO PROVIDE EARLY PRESSURE CONTROL; CORNEOSCLERAL GRAFT WAS SECURED WITH 9¿0 NYLON SUTURES; AND WATERTIGHT CONJUNCTIVAL CLOSURE WAS ACHIEVED WITH 7¿0 VICRYL SUTURES. COMPLICATIONS INCLUDED: PROLONGED HYPHEMA (N=1), CORNEAL EDEMA (N=2), MOTILITY DISORDER/DIPLOPIA (N=1), SHALLOW ANTERIOR CHAMBER (AC) (N=5), CHOROIDAL DETACHMENT (N=7), PROLONGED IRITIS (N=4), TUBE RELATED COMPLICATIONS (N=2). THE FAILURES (N=3) WERE DUE TO: SUPRACHOROIDAL HEMORRHAGE (N=2), ONE OF WHICH WAS WITH PERSISTENT HYPOTONY (N=1); AND IOP HIGHER THAN UPPER LIMIT (N=1), WHICH UNDERWENT A CYCLODESTRUCTIVE PROCEDURE FOR IOP CONTROL. THESE 2 LATTER CASES EVENTUALLY DEVELOPED NO LIGHT PERCEPTION (N=2) VISION. OTHER JNJ PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM. THERE WERE NO FURTHER INTERVENTIONS REPORTED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475748 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention