BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT

    MDR report key: 12022676 · Received June 18, 2021

    Report

    Report Number
    9614546-2021-07236
    Event Type
    Injury
    Date Received
    June 18, 2021
    Report Date
    June 17, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: AGE RANGE BETWEEN 20-88 YEARS OF AGE. SEX/GENDER: MALE GENDER, 41.3%. PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. RACE/ETHNICITY: WHITE 39 (84.8%), BLACK 7 (15.2%). DATE OF EVENT: JULY 23, 2020. THE DATE ARTICLE WAS PUBLISHED. BRAND NAME: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE) THERE IS NO INDICATION THE DEVICE HAS BEEN EXPLANTED. MANUFACTURER TELEPHONE NUMBER: (B)(4). 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. WEINER A.J., WEINER, Y., WEINER, A. (2020). CORNEAL PARAMETERS AFTER TUBE-SHUNT IMPLANTATION THROUGH THE CILIARY SULCUS. AMERICAN ACADEMY OF OPHTHALMOLOGY 4(1), PP. 32-41. 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: CORNEAL PARAMETERS AFTER TUBE-SHUNT IMPLANTATION THROUGH THE CILIARY SULCUS. A RETROSPECTIVE, INTERVENTIONAL CASE STUDY WAS DONE TO MONITOR BILATERAL CORNEAL PARAMETERS AFTER UNILATERAL BAERVELDT 350 TUBE-SHUNT IMPLANTATION THROUGH THE CILIARY SULCUS. A TOTAL OF 46 PATIENTS WITH SEVERE UNCONTROLLED GLAUCOMA WAS TREATED WITH SULCUS TUBE-SHUNT IMPLANTATION IN 1 PSEUDOPHAKIC EYE (N=19 RIGHT EYE AND N=27 LEFT EYE). A BAERVELDT 350 TUBE SHUNT (ADVANCED MEDICAL OPTICS) WAS IMPLANTED IN ALL EYES, WITH A RIPCORD VALVE CONSISTING OF AN INTRALUMINAL 5-0 NYLON SUTURE (ETHICON) AND A 6-0 VICRYL SUTURE (ETHICON) TIED TIGHTLY AROUND THE TUBE 1 MM FROM THE PLATE OCCLUDING THE TUBE TO PREVENT EARLY POSTOPERATIVE HYPOTONY. THE SHUNT PLATE WAS PLACED UNDER THE RECTI MUSCLES AND FIXATED TO BARE SCLERA 9 MM FROM THE LIMBUS WITH 2 INTERRUPTED 8-0 NYLON SUTURES (ETHICON). THE TUBES WERE FIXATED TO THE SCLERA 1 MM FROM THEIR SCLERAL ENTRY WITH A TRIPLE-LOOP 10-0 NYLON SUTURE (ETHICON) AND A SINGLE 10-0 NYLON SUTURE SEVERAL MILLIMETERS MORE POSTERIORLY. FINALLY, THE INITIAL CONJUNCTIVAL AND TENON¿S INCISION WAS CLOSED IN 2 LAYERS USING AN 8-0 VICRYL SUTURE (ETHICON), CLOSING TENON¿S CAPSULE IN A RUNNING-LOCKING FASHION AND THE CONJUNCTIVA IN A RUNNING-NON-LOCKING WATERTIGHT FASHION. IN THE IMMEDIATE FOLLOW-UP PERIOD AFTER THE SULCUS TUBE IMPLANTATION, HYPHEMA WAS FOUND AND WAS DOCUMENTED AS MICROSCOPIC TO 2 TO 3 MM, IN 11 OF THE 46 SURGICAL EYES. ALL HYPHEMAS RESOLVED WITHIN DAYS TO 2 WEEKS WITH NO INTERVENTION. SEROUS CHOROIDAL DETACHMENT WAS ALSO SEEN IN 3 EYES. LASER CAPSULOTOMY WAS PERFORMED IN 5 EYES AND ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR (VEGF) INJECTIONS WAS PERFORMED IN 4 EYES. AT 24 MONTHS, THE CENTRAL CORNEAL ENDOTHELIAL CELL DENSITY (CECD) IN THE SURGICAL EYE DECREASED BY 8.6% FROM 1807 CELLS/MM2 TO 1651 CELLS/MM2. OTHER JNJ PRODUCTS WERE MENTIONED BUT IT IS NOT CLEAR TO WHICH DEVICE THE COMPLAINTS ARE RELATED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924853 UNK_GLAUCOMA SHUNT_BAERVELDT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNK_GLAUCOMA SHUNT_BAERVELDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention