BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 17252887 · Received July 3, 2023

    Report

    Report Number
    3012236936-2023-01514
    Event Type
    Injury
    Date Received
    July 3, 2023
    Report Date
    July 3, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: 78 YEARS OLD SECTION A3: 1 FEMALE PATIENT SECTION A4 AND A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. IMPLANT WAS PLACED IN (B)(6) 2014, REFERRAL TO A CLINIC IN (B)(6) 2019. 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 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. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: VÄLIMÄKI, J.; NUKAREDDY, P.; UUSITALO, H.; AAPOLA, U.; INTRALUMINAL DEPOSITS: A RARE CAUSE OF GLAUCOMA DRAINAGE IMPLANT TOTAL OBSTRUCTION; EUROPEAN JOURNAL OF OPHTHALMOLOGY 2023, VOL. 33(1) 307¿311; DOI: 10.1177/11206721221100074 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: INTRALUMINAL DEPOSITS: A RARE CAUSE OF GLAUCOMA DRAINAGE IMPLANT TOTAL OBSTRUCTION A CASE REPORT WAS DONE TO DESCRIBE THE UNFORESEEN COMPLICATION OF TOTAL OBSTRUCTION OF A GLAUCOMA DRAINAGE IMPLANT (GDI) TUBE LUMEN BY WHITE DEPOSIT MATERIAL AND TO PRESENT A PRELIMINARY REPORT IDENTIFYING THE COMPOSITION OF THIS MATERIAL. TWO SUBJECTS WITH A HIGH INTRAOCULAR PRESSURE (IOP) DUE TO TOTAL OBSTRUCTION OF A GDI TUBE WERE REVIEWED. A 78-YEAR-OLD PSEUDOPHAKIC WOMAN WITH PSEUDOEXFOLIATIVE GLAUCOMA WAS IMPLANTED WITH A BAERVELDT 250 MM2 (JOHNSON & JOHNSON VISION) ON THE RIGHT EYE IN(B)(6)2014. IN (B)(6) 2019, SHE WAS REFERRED TO THE EYE CLINIC WITH BAERVELDT TUBE EXPOSURE THROUGH THE CONJUNCTIVA IN HER RIGHT EYE WITH AN IOP OF 34 MMHG. APPROXIMATELY 5 MM OF THE BAERVELDT IMPLANT TUBE WAS EROSIONED THROUGH THE CONJUNCTIVA AND THE TUBE EXHIBITED INTRALUMINAL MATERIAL IN THE EXPOSED AREA. A SURGICAL MICROSCOPE EXAMINATION SHOWED THE GDI TUBE LUMEN TO BE FULL OF WHITE DEPOSIT MATERIAL (TOTAL OBSTRUCTION). THE TUBE LUMEN WAS SWEPT WITH A 5-0 POLYPROPYLENE SUTURE TO REMOVE THE INTRALUMINAL MATERIAL WHICH WERE FOUND TO BE ANTIGLAUCOMA DRUG COMPONENTS. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253189 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS 103-250

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention