BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 21510070 · Received March 3, 2025

    Report

    Report Number
    3012236936-2025-000059
    Event Type
    Injury
    Date Received
    March 3, 2025
    Report Date
    March 3, 2025
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    UDI-DI
    5050474513013
    PMA / PMN Number
    K905129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B3 - DATE OF EVENT: EXACT DATE NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS FEBRUARY 1, 2025. SECTION D4 - LOT NUMBER: UNKNOWN/NOT PROVIDED SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D6B - EXPLANT DATE: N/A, DEVICE REMAINS IMPLANTED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H6 - HEALTH EFFECT - CLINICAL CODE 4581: NO CODE AVAILABLE (SHALLOWING OF THE ANTERIOR CHAMBER). SECTION H6 - HEALTH EFFECT - CLINICAL CODE 4810 (CHOROIDAL HEMORRHAGE): DUE TO SYSTEM. LIMITATIONS CODE 4877 (CHOROIDAL DETACHMENT) COULD NOT BE SELECTED. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED (THE DEVICE REMAINS IMPLANTED). THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED, AND THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED, AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. CITATION: NAGATA, M., MATSUSHIMA, H., MUKAI, K., SENOO, T., & NISHI, O. (2023). INHIBITION OF ANTERIOR CAPSULE OPACIFICATION AND CONTRACTION BY THE ELEVATED ANTERIOR RIM OF THE INTRAOCULAR LENS OPTIC. JAPANESE JOURNAL OF OPHTHALMOLOGY, 67(6), 693¿698. HTTPS://DOI.ORG/10.1007/S10384-023-01013-7 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: CASE REPORT OF A PEDIATRIC PATIENT WITH REFRACTORY SECONDARY GLAUCOMA TREATED WITH THE BAERVELDT¿ GLAUCOMA IMPLANT INTRODUCTION: THE FIRST-LINE SURGICAL TREATMENT FOR PEDIATRIC GLAUCOMA IS TRABECULOTOMY; HOWEVER, THERE ARE FEW REPORTS OF SURGICAL CASES FOR REFRACTORY CASES WHERE TRABECULOTOMY HAS FAILED. WE REPORT A CASE OF A REFRACTORY SECONDARY PEDIATRIC GLAUCOMA THAT EXPERIENCED ELEVATED INTRAOCULAR PRESSURE AGAIN AFTER FOUR TRABECULOTOMIES, WHICH WAS TREATED WITH THE BAERVELDT¿ GLAUCOMA IMPLANT. CASE REPORT: A 15-YEAR-OLD MALE PATIENT WITH LEFT PEDIATRIC GLAUCOMA SECONDARY TO STURGE-WEBER SYNDROME, WHO HAD UNDERGONE FOUR TRABECULOTOMIES SINCE THE AGE OF 2. AT THE AGE OF 10, HE DEVELOPED SUBRETINAL HEMORRHAGE INVOLVING THE MACULA AND UNDERWENT VITRECTOMY. AROUND THE AGE OF 14, THE INTRAOCULAR PRESSURE IN THE LEFT EYE ROSE AGAIN, EXCEEDING 30 MMHG UNDER FULL MEDICATION, WITH SIGNIFICANT GLAUCOMATOUS CHANGES IN THE OPTIC NERVE. THEREFORE, A BAERVELDT¿ 250 GLAUCOMA IMPLANT WAS INSERTED UNDER GENERAL ANESTHESIA. THE TUBE WAS COMPLETELY LIGATED WITH 8-0 VICRYL AND INSERTED INTO THE ANTERIOR CHAMBER. POSTOPERATIVELY, INTRAOCULAR PRESSURE STABILIZED AROUND 30 MMHG, AND THE PATIENT WAS MONITORED IN AN OUTPATIENT SETTING WHILE AWAITING TUBE OPENING. ON THE 10TH POSTOPERATIVE DAY, THE PATIENT PRESENTED TO THE CLINIC WITH A SUDDEN DECLINE IN VISION; THE INTRAOCULAR PRESSURE IN THE LEFT EYE HAD DECREASED TO 14 MMHG, AND SIGNIFICANT CHOROIDAL DETACHMENT AND A SHALLOW ANTERIOR CHAMBER WERE NOTED. AFTER ATROPINE EYE DROPS, THE ANTERIOR CHAMBER DEPTH NORMALIZED BY THE 12TH POSTOPERATIVE DAY, AND THE CHOROIDAL DETACHMENT RESOLVED BY THE THIRD WEEK POSTOPERATIVELY. CONCLUSION: THE BAERVELDT¿ GLAUCOMA IMPLANT IS ONE OF THE EFFECTIVE TREATMENT OPTIONS FOR REFRACTORY SECONDARY PEDIATRIC GLAUCOMA; HOWEVER, IT CAN CAUSE SUDDEN FLUCTUATIONS IN INTRAOCULAR PRESSURE, INDICATING THE NEED FOR CAREFUL POSTOPERATIVE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777810 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG103-250 5050474513013

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Required Intervention