BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 17213585 · Received June 27, 2023

    Report

    Report Number
    3012236936-2023-01595
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    January 23, 2023
    Report Date
    June 27, 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 A, PATIENT INFORMATION: A4, A5: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION B3: DATE OF EVENT: AS THE EVENT DATE IS NOT AVAILABLE, THE DATE OF THE ARTICLE WAS PROVIDED. SECTION D4: MODEL NUMBER: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D4: CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS 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, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE WAS NO INDICATION THAT THE DEVICE WAS 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. SECTION H6- HEALTH EFFECT - IMPACT CODE: 4625 IS TO CAPTURE SECONDARY SURGICAL INTERVENTION. AMOOZADEH, S.A., YANG, M.C., LIN, K.Y.. A CASE OF REFRACTORY OPEN-ANGLE GLAUCOMA WITH FAILED BAERVELDT GLAUCOMA IMPLANT AND TRABECULECTOMY TREATED WITH AB EXTERNO XEN GEL STENT PLACEMENT. JOURNAL OF CURRENT GLAUCOMA PRACTICE 2022;16(3):192-194. DOI: 10.5005/JP-JOURNALS-10078-1371. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE 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: A CASE OF REFRACTORY OPEN-ANGLE GLAUCOMA WITH FAILED BAERVELDT GLAUCOMA IMPLANT AND TRABECULECTOMY TREATED WITH AB EXTERNO XEN GEL STENT PLACEMENT. A CASE WAS DONE TO REPORT A SUCCESSFUL INTRAOCULAR PRESSURE (IOP) MANAGEMENT IN A PATIENT WITH REFRACTORY PRIMARY OPEN-ANGLE GLAUCOMA (POAG) FOLLOWING IMPLANTATION OF XEN GEL IMPLANT IN THE SAME HEMISPHERE AS PRIOR FAILED FILTERING SURGERIES [I.E., BAERVELDT GLAUCOMA IMPLANT (BGI) AND TRABECULECTOMY BLEB)]. THE PATIENT HAD A SUPEROTEMPORAL BGI IN BOTH EYES (OU) AND A SCARRED TRABECULECTOMY BLEB SUPERIORLY IN THE RIGHT EYE (OD). COMPLAINT WAS PERSISTENTLY ELEVATED IOP DESPITE PRIOR FILTERING SURGERIES. TREATMENT DONE WAS THE OPEN CONJUNCTIVA AB EXTERNO XEN GEL IMPLANT (ALLERGAN INC., IRVINE, CA) PLACEMENT. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120388 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention