BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 15021839 · Received July 14, 2022

    Report

    Report Number
    3012236936-2022-01859
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    April 17, 2021
    Report Date
    July 14, 2022
    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

    PATIENT WEIGHT AND ETHNICITY: UNKNOWN/ASKED BUT DID NOT PROVIDE. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS APR 17, 2021. BRAND NAME: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. MODEL NUMBER: THE MODEL NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. CATALOG NUMBER: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). CITATION: ROHOWETZ, L. J., PATEL, N. A., QUAN, A. V., FAN, K. C., YANNUZZI, N. A., REYES-CAPÓ, D. P., LAURA, D., ANSARI, Z. A., PATEL, U., DUBOVY, S. R., & FLYNN, H. W., JR (2021). AGROBACTERIUM RADIOBACTER ENDOPHTHALMITIS ASSOCIATED WITH BAERVELDT TUBE EXPOSURE. CASE REPORTS IN OPHTHALMOLOGY, 12(3), PP. 921¿926. HTTPS://DOI.ORG/10.1159/00051666. 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 LITERATURE REVIEW: ARTICLE: AGROBACTERIUM RADIOBACTER ENDOPHTHALMITIS ASSOCIATED WITH BAERVELDT TUBE EXPOSURE. A CASE REPORT WAS DONE TO DESCRIBE A PSEUDOPHAKIC PATIENT WITH AGROBACTERIUM RADIOBACTER ENDOPHTHALMITIS SECONDARY TO AN EXPOSED BAERVELDT TUBE AND DISCUSS THE TREATMENT WHICH INVOLVED PARS PLANA VITRECTOMY (PPV) AND REMOVAL OF BOTH IMPLANTS. AN 85-YEAR OLD MALE WITH A HISTORY OF CHRONIC ANGLE CLOSURE GLAUCOMA AND SUPEROTEMPORAL AND INFERONASAL BAERVELDT TUBE INSERTION FOR 8 YEARS WAS PRESENTED TO THE EMERGENCY DEPARTMENT WITH LATE-ONSET ENDOPHTHALMITIS ASSOCIATED WITH EXPOSURE OF AN INFERONASAL BAERVELDT TUBE. THE PATIENT WAS INITIALLY TREATED WITH ANTERIOR CHAMBER PARACENTESIS AND INTRAVITREAL ANTIBIOTICS AND SUBSEQUENTLY UNDERWENT EXPLANTATION OF THE GLAUCOMA DRAINAGE IMPLANT (GDI). AQUEOUS HUMOR CULTURE REVEALED AGROBACTERIUM RADIOBACTER INFECTION RESISTANT TO CEFAZOLIN, CEFTAZIDIME, AMIKACIN, TOBRAMYCIN, AND TRIMETHOPRIM-SULFAMETHOXAZOLE. AFTER INITIAL IMPROVEMENT, THE PATIENT HAD CLINICAL WORSENING AND WAS DIAGNOSED WITH RECURRENCE. SUBSEQUENT TREATMENT INVOLVED EXPLANTATION OF THE SECOND GDI IN ADDITION TO PARS PLANA VITRECTOMY WITH SILICONE OIL INFUSION, INTRAOCULAR LENS REMOVAL, AND ADMINISTRATION OF INTRAVITREAL ANTIBIOTICS. THE PATIENT WAS SUBSEQUENTLY LOST TO FOLLOW-UP AND ULTIMATELY PASSED AWAY DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402608 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNK-GLAUCOMA SHUNT_BAERVELDT

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention