BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 17244097 · Received July 1, 2023

    Report

    Report Number
    3012236936-2023-01655
    Event Type
    Injury
    Date Received
    July 1, 2023
    Date of Event
    April 27, 2022
    Report Date
    June 30, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K905129
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4 AND A5: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION B3: DATE OF EVENT: (B)(6) 2022 (THE DATE ARTICLE WAS ACCEPTED). SECTION D4: MODEL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: CATALOG NUMBER: UNKNOWN, INFORMATION 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: IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION D6B: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE) THERE IS NO INDICATION THE DEVICE HAS BEEN EXPLANTED. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: KILGORE KP, FELLMAN RL, GROVER DS. ISTAT (INTRALUMINAL SUTURE TRANSFIXED AND TITRATABLE) TECHNIQUE FOR LIGATURE-FREE REVERSAL OF LONG-TERM DRAINAGE IMPLANT HYPOTONY. AM J OPHTHALMOL CASE REP. 26 (2022) 101569 (PP. 1-3). ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. 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: ISTAT (INTRALUMINAL SUTURE TRANSFIXED AND TITRATABLE) TECHNIQUE FOR LIGATURE-FREE REVERSAL OF LONG-TERM DRAINAGE IMPLANT HYPOTONY. A CASE REPORT WAS DONE TO DESCRIBE THE ISTAT (INTRALUMINAL SUTURE TRANSFIXED AND TITRATABLE) TECHNIQUE, AN IMPROVEMENT ON PRIOR TUBE OCCLUSION METHODS, ALLOWING FOR VARIABLE FLOW. THE PATIENT UNDERWENT AN UNCOMPLICATED SUPERIOR-TEMPORAL PLACEMENT OF A BAERVELDT 350 GLAUCOMA DRAINAGE DEVICE (GDD; JOHNSON AND JOHNSON VISION, SANTA, CA, USA) WITH TUBE PLACEMENT IN THE SULCUS IN THE RIGHT EYE. TWO YEARS AFTER, THE PATIENT HAD VISUAL ACUITY (VA) 20/200 RIGHT EYE (OD), 20/70 WITH PINHOLE, TRACE CORNEAL EDEMA IN THE GRAFT, AN INTRAOCULAR PRESSURE (IOP) 10 MMHG AND WAS ON STEROIDS. PATIENT WAS THEN LOST TO FOLLOW UP. AFTER ANOTHER 2 YEARS, THE PATIENT HAD WITH VA 20/80 OD, IOP 5 MMHG (HYPOTONY), BUT WITH NEW VITREOMACULAR TRACTION AND MILD MACULAR EDEMA. THE PATIENT UNDERWENT A COMPLETE TUBE OCCLUSION WITH A LARGE-BULBED 4¿0 POLYPROPYLENE SUTURE STENT PLACED VIA AN AB INTERNO APPROACH. ON POSTOPERATIVE DAY 1, IOPS INCREASED TO >40 MMHG AND REMAINED ELEVATED IN THE 25¿30 MMHG RANGE 2¿3 WEEKS AFTER THE STENT PLACEMENT ON MAXIMALLY-TOLERATED MEDICATIONS. THUS, THE PATIENT UNDERWENT A SECOND REVISION USING THE ISTAT TECHNIQUE WITH PARTIAL OCCLUSION. AFTER THIS SECOND REVISION, THE PATIENT HAS REMAINED IOPS WELL-CONTROLLED, OFF ALL GLAUCOMA MEDICATIONS, AND VISION IMPROVED BACK TO BASELINE LEVEL OF 20/50. THERE WERE NO FURTHER INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22424 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNK-GLAUCOMA SHUNT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention