BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 19901035 · Received August 2, 2024

    Report

    Report Number
    3012236936-2024-000206
    Event Type
    Injury
    Date Received
    August 2, 2024
    Report Date
    August 2, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: GAN, Y., JALAL, M., & DIN, N. (2024). BAERVELDT GLAUCOMA IMPLANT WITH SUPRAMID© RIPCORD STENT IN NEOVASCULAR GLAUCOMA: A CASE SERIES. INTERNATIONAL JOURNAL OF OPHTHALMOLOGY, 17(2), 265¿271. HTTPS://DOI.ORG/10.18240/IJO.2024.02.06. SECTION A2, A3A, A3B, A4, A5, A6: PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. SECTION B3: DATE OF EVENT: UNKNOWN/ NOT PROVIDED, THE BEST ESTIMATE DATE IS FROM 2016 TO 2021. SECTION D4: MODEL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: CATALOG NUMBER: A COMPLETE CATALOG # IS UNKNOWN. SECTION D4: LOT NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IMPLANT DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: EXPLANT DATE: NOT APPLICABLE AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION E1: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. SECTION E1: TELEPHONE: UNKNOWN/NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL LOT/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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THERE WAS A RETROSPECTIVE CASE SERIES DONE TO REPORT THE OUTCOME OF BAERVELDT GLAUCOMA IMPLANT (BGI) WITH SUPRAMID© RIPCORD USE IN NEOVASCULAR GLAUCOMA (NVG). A TOTAL OF 26 EYES FROM 24 PATIENTS WITH PROLIFERATIVE DIABETIC RETINOPATHY, OCULAR ISCHAEMIC SYNDROME OR CENTRAL RETINAL VEIN OCCLUSION WERE INCLUDED IN THE STUDY. ALL PATIENTS WERE IMPLANTED WITH THE BGI (ADVANCED MEDICAL OPTICS, INC) OF EITHER SIZE 250 MM2 OR 350 MM2 WITH THE LUMEN OF THE TUBES STENTED WITH A 3/0 SUPRAMID EXTRA SUTURE (S. JACKSON INC) WITHOUT TUBE LIGATION OR VENTING SLITS. IT WAS REPORTED THAT VISUAL ACUITY (VA) REMAINED UNCHANGED IN N=6 EYES AND WORSENED IN N=10 EYES. THERE WAS EARLY POSTOPERATIVE HYPOTONY THAT OCCURRED IN N=2 EYES ON POSTOPERATIVE DAY 1 AND N=1 EYE AT 1 MONTH, WITH INTRAOCULAR PRESSURE (IOP) RANGING FROM 3 TO 5 MM HG. THE INTRAOCULAR PRESSURE (IOP) PICKED UP SPONTANEOUSLY IN ALL PATIENTS. NONE OF THE PATIENTS HAD CLINICAL SIGNS OF HYPOTONY OR REQUIRED ADDITIONAL PROCEDURES TO CORRECT THE HYPOTONY. THE HYPERTENSIVE PHASE (HP) OCCURRED IN N=15 EYES WITHIN THE FIRST 3 MONTHS POSTOPERATIVELY. THIS WAS TREATED WITH ANTIGLAUCOMA MEDICATIONS WHILE WAITING FOR THE SAFE REMOVAL OF THE SUPRAMID RIPCORD TO ALLOW FOR ADEQUATE IOP CONTROL. THREE EYES (N=3) HAD HYPOTONY WITH SHALLOW ANTERIOR CHAMBER (AC) AFTER SUPRAMID REMOVAL, AND TWO OF THEM HAD SUPRAMID REMOVED AT 6 WEEKS FOR UNCONTROLLED IOP AND BOTH REQUIRED AC REFORMATION WITH VISCOELASTIC AND REINTUBATION OF THE TUBE. THE LATE POST-OPERATIVE COMPLICATIONS INCLUDE ONE EYE (N=1) WHICH HAD PERSISTENT HIGH IOP BECAUSE OF A BLOCKED TUBE BY IRIS TISSUE AND REQUIRED REPOSITIONING OF THE TUBE. ONE EYE (N=1) HAD SEVERE FIBRINOUS AC REACTION AFTER SUPRAMID REMOVAL AND WAS TREATED WITH INTRACAMERAL RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR (RTPA) INJECTION, ONE EYE (N=1) HAD JUTTING SUPRAMID FROM THE CONJUNCTIVA WHICH WAS RE-SUTURED, AND ONE EYE (N=1) HAD VITREOUS HAEMORRHAGE SECONDARY TO UNCONTROLLED PROLIFERATIVE DIABETIC RETINOPATHY WHICH REQUIRED VITRECTOMY FOR RETINAL STABILIZATION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT DOCUMENTS THE PATIENT WITH INCREASED INTRAOCULAR PRESSURE BECAUSE OF A BLOCKED TUBE BY IRIS TISSUE AND REQUIRED REPOSITIONING OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371972 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT GLAUCOMA SHUNT HBF AMO MANUFACTURING NETHERLANDS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other| R