BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAERVELDT SHUNT

    MDR report key: 14995394 · Received July 12, 2022

    Report

    Report Number
    3012236936-2022-01846
    Event Type
    Malfunction
    Date Received
    July 12, 2022
    Date of Event
    December 24, 2021
    Report Date
    June 18, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE: 43¿91 YEARS. GENDER: MEN / WOMEN: 37 / 14. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS (B)(6) 2021. 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). 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN THE REPORT SUBMITTED JULY 12, 2022 ((B)(4)), AN INCORRECT CATALOG NUMBER WAS INADVERTENTLY SUBMITTED. THIS REPORT CONTAINS THE CORRECTED CATALOG NUMBER. SECTION D4 - CATALOG #: 23030818. 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: FACTORS ASSOCIATED WITH THE SURGICAL OUTCOMES OF BAERVELDT GLAUCOMA IMPLANT FOR OPEN-ANGLE GLAUCOMA, AN AGE-RELATED EYE DISEASE A RETROSPECTIVE STUDY WAS DONE TO IDENTIFY THE FACTORS ASSOCIATED WITH THE SURGICAL OUTCOMES OF BAERVELDT GLAUCOMA IMPLANT (BGI) FOR OPEN-ANGLE GLAUCOMA (OAG). A TOTAL OF 51 CONSECUTIVE OAG PATIENTS UNDERWENT BGI AND WERE DIVIDED INTO TWO GROUPS ACCORDING TO MEDIAN AGE (72 YEARS): YOUNGER GROUP (<72 YEARS; N=25) AND OLDER GROUP (>72 YEARS; N=26). THE PATIENTS WERE ALSO GROUPED ACCORDING TO SURGICAL SUCCESS (INTRAOCULAR PRESSURE (IOP) RANGE): 6¿21 MMHG (CRITERION A), 6¿18 MMHG (CRITERION B), AND 6¿15 MMHG (CRITERION C). IMPLANT MODEL BG101-350 (ABBOTT MEDICAL OPTICS) WAS CHOSEN IN THE EYES WITHOUT A HISTORY OF VITRECTOMY, WHILE BG102-350 (ABBOTT MEDICAL OPTICS) WAS SELECTED IN THE EYES WITH A HISTORY OF VITRECTOMY. THE REASONS FOR SURGICAL FAILURE WERE: >HYPOTONY (N=1 EYE) >BGI REMOVAL (N=1 EYE) >ELEVATED IOP (N=2 EYES CRITERIA A; N=7 EYES CRITERIA B; AND N=26 EYES CRITERIA C) ELEVATED IOP OF 1, 6, AND 19 EYES FOR CRITERIA A, B, AND C, RESPECTIVELY, WERE MANAGED BY GLAUCOMA MEDICATIONS. ONE EYE NEEDED BLEB REVISION, MICROPULSE TRANSSCLERAL CYCLOPHOTOCOAGULATION, AND ADDITIONAL BGI SURGERY AFTER SURGICAL FAILURE FOR CRITERIA A, B, AND C DUE TO ELEVATED IOP. EARLY POSTOPERATIVE COMPLICATIONS (ONSET =1 MONTH) INCLUDE: YOUNGER GROUP: >SHALLOW OR FLAT ANTERIOR CHAMBER (N=6) >CHOROIDAL DETACHMENT (N=7) >HYPHEMA (N=9) >TUBE CORNEAL TOUCH (N=1) >TUBE IRIS TOUCH (N=4) >TUBE OCCLUSION (N=1) >SCLERA PATCH EXPOSURE (N=1) >BLEBITIS SUSPECTED (N=1) >WOUND LEAK (N=2) OLDER GROUP: >SHALLOW OR FLAT ANTERIOR CHAMBER (N=2) >CHOROIDAL DETACHMENT (N=8) >HYPOTONY MACULOPATHY (N=1) >HYPHEMA (N=7) >TUBE CORNEAL TOUCH (N=3) >TUBE IRIS TOUCH (N=2) >WOUND LEAK (N=1) LATE POSTOPERATIVE COMPLICATIONS (ONSET >1 MONTH) INCLUDE: YOUNGER GROUP: >SHALLOW OR FLAT ANTERIOR CHAMBER (N=1) >CHOROIDAL DETACHMENT (N=1) >HYPOTONY MACULOPATHY (N=1) >CYSTOID MACULAR EDEMA (N=1) OLDER GROUP: >SHALLOW OR FLAT ANTERIOR CHAMBER (N=1) >CHOROIDAL DETACHMENT (N=2) >TUBE CORNEAL TOUCH (N=1) >TUBE OCCLUSION (N=1) OTHER JNJ PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM. NO FURTHER INTERVENTIONS WERE PROVIDED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT IS FOR MODEL BG102-350 PRODUCT PROBLEM. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTED ADVERSE EVENT FOR THIS MODEL. SEPARATE REPORTS ARE ALSO BEING SUBMITTED FOR THE OTHER MENTIONED MODEL, BG101-350 IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713886 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG102-350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown