BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 19901059 · Received August 2, 2024

    Report

    Report Number
    3012236936-2024-000214
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    January 24, 2024
    Report Date
    August 2, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: AGE: UNKNOWN/NOT PROVIDED. SECTION A3A: SEX: 35 (52.2%) MALE; 32 (47.8%) FEMALE. SECTION A3B: GENDER: UNKNOWN/NOT PROVIDED. SECTION A4: WEIGHT: UNKNOWN/NOT PROVIDED. SECTION A5: ETHNICITY: UNKNOWN/NOT PROVIDED. SECTION A6: RACE: 36 (53.7%) WHITE; 18 (26.9%) AFRICAN AMERICAN; 5 (7.5%) HISPANIC; 3 (4.4%) ASIAN; 5 (7.5%) DECLINED TO SPECIFY. SECTION B3: DATE OF EVENT: (B)(6) 2024 (DATE ARTICLE WAS PUBLISHED). SECTION D4: MODEL NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4: CATALOG NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UNIQUE IDENTIFIER (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: UNKNOWN/NOT PROVIDED. SECTION H3: 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. SECTION H6: HEALTH EFFECT - CLINICAL CODE 4581 IS TO CAPTURE SHALLOWING OR COLLAPSING OF THE ANTERIOR CHAMBER, DEVICE DECENTERED OR DISLOCATED OR TILTED SUBLUXATED OR WRONG POSITION, AND EYE ANATOMY ISSUE. CITATION: HALLAJ, S., WONG, J.C., HOCK, L.E., KOLOMEYER, N.N., SHUKLA, A.G., PRO, M.J., MOSTER, M.R., MYERS, J.S., RAZEGHINEJAD, R., LEE, D. (2024). LONG-TERM SURGICAL OUTCOMES OF GLAUCOMA DRAINAGE IMPLANTS IN EYES WITH PREOPERATIVE INTRAOCULAR PRESSURE LESS THAN 19 MMHG. JOURNAL OF OPHTHALMOLOGY, ARTICLE ID 6624021, PP. 1-7. DOI: HTTPS://DOI.ORG/10.1155/2024/6624021. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION 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: LONG-TERM SURGICAL OUTCOMES OF GLAUCOMA DRAINAGE IMPLANTS IN EYES WITH PREOPERATIVE INTRAOCULAR PRESSURE LESS THAN 19 MMHG. A RETROSPECTIVE REVIEW REPORTS ON PATIENTS WHO UNDERWENT GLAUCOMA DRAINAGE IMPLANT (GDI) SURGERY AND HAD BASELINE INTRAOCULAR PRESSURE (IOP) OF =18 MMHG WITH AT LEAST ONE YEAR OF FOLLOW-UP. A TOTAL OF 67 PATIENTS (N=67 EYES) WERE INCLUDED IN THIS STUDY. PATIENTS HAD PRIMARY OPEN-ANGLE GLAUCOMA (POAG), SEVERE, MODERATE AND MILD GLAUCOMA. GDIS WERE CATEGORIZED AS VALVED (65.7%; AHMED FP7; NEW WORLD MEDICAL, EDISON COURTRANCHO CUCAMONGA, CALIFORNIA, USA) AND NON-VALVED (34.3%; INCLUDING BAERVELDT [ABBOTT MEDICAL OPTICS, ABBOTT PARK, ILLINOIS, USA], MOLTENO [MOLTENO OPHTHALMIC LIMITED, DUNEDIN, NEW ZEALAND], AND AHMED VALVELESS CLEARPATH [ACP, NEW WORLD MEDICAL, EDISON RANCHO CUCAMONGA, CALIFORNIA, USA]). POST-OP COMPLICATIONS (TOTAL: N=16 EYES) INCLUDED: GDI EXPOSURE (N=5 EYES), SHALLOW ANTERIOR CHAMBER (N=3 EYES), STRABISMUS (N=1 EYE), INFLAMMATION (N=3 EYES): IN POST-OP MONTH 3 (N=2 EYES); AND FOLLOWING KERATOCONJUNCTIVITIS IN POST-OP YEAR 3 (N=1), ENDOPHTHALMITIS 6 WEEKS AFTER THE GDI SURGERY (N=1 EYE), HYPOTONY (IOP < 5MMHG) (N=3 EYES) ONCE DURING THE FOLLOW-UP. 19 REOPERATIONS ON 13 EYES WERE RECORDED DURING THE FOLLOW-UP PERIOD; ONLY 5 EYES NEEDED FURTHER GLAUCOMA SURGERY TO CONTROL IOP (3 GDIS AND 2 TRANS-SCLERAL DIODE LASER CYCLOPHOTOCOAGULATIONS). 8 GDI REVISIONS ON 5 EYES WITH GDI EROSION WERE OBSERVED, AND 3 HAD MORE THAN 1 REVISION. GDI EXPLANT AND INSERTION OF NEW GDI IMPLANT WAS DONE DUE TO PLATE SHIFT (N=1 EYE). GDI REMOVAL WAS DONE (N=2 EYES); ONE DUE TO ENDOPHTHALMITIS AND GDI EROSION THROUGH CONJUNCTIVA AND THE OTHER DUE TO STRABISMUS. THE CUMULATIVE ONE-YEAR FAILURE RATE WAS 56.7%. GDI FAILED TO CONTROL THE IOP IN 52.3% OF THE EYES, 2 EYES (2.9%) NEEDED FURTHER GLAUCOMA SURGERY TO CONTROL IOP, AND PROGRESSED TO NO LIGHT PERCEPTION (NLP) (N=1 EYE) WITHIN THE FIRST YEAR. IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES IMPLANTED WITH BAERVELDT IMPLANT OR THE OTHER PRODUCT. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT IS FOR MODEL UNKNOWN MODEL BAERVELDT ADVERSE EVENT. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTED PRODUCT PROBLEM FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398866 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention