BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 14963385 · Received July 8, 2022

    Report

    Report Number
    3012236936-2022-01788
    Event Type
    Injury
    Date Received
    July 8, 2022
    Report Date
    July 12, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K905129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE/DATE OF BIRTH: EXACT AGE NOT PROVIDED, MEAN AGE FOR GROUP UG: 52.79 YEARS AND GROUP OFG: 51.11 (YEARS). PATIENT SEX/GENDER: GROUP UG: FEMALE (62.5%), MALE (35.5%) AND GROUP OFG: FEMALE (39.5%), MALE (60.5%). PATIENT: PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. PATIENT: RACE/ETHNICITY: UNKNOWN/NOT PROVIDED. DATE OF EVENT: (B)(6) 2022. THE DATE ARTICLE WAS ACCEPTED. SERIAL NUMBER: UNKNOWN, INFORMATION 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: N/A (NOT APPLICABLE) THERE IS NO INDICATION THE DEVICE HAS BEEN EXPLANTED. 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. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). CITATION: CAZANA IM., BÖHRINGER D., REINHARD T., ANTON A., NESS T., LÜBKE J. (2022). A COMPARISON OF LONG-TERM RESULTS AFTER BAERVELDT 250 IMPLANTATION IN ADVANCED UVEITIC VS. OTHER FORMS OF GLAUCOMA. GRAEFE'S ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY. DOI: HTTPS://DOI.ORG/10.1007/S00417-022-05612-X. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER REVIEW ON JUN 14, 2024, IT WAS NOTED THAT SECTION D4 CATALOG NUMBER WAS SUBMITTED AS BG103-250 ON THE INITIAL MDR, BUT SHOULD BE 23030819. THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT. THE FOLLOWING FIELD HAS BEEN UPDATED ACCORDINGLY: SECTION D4: CATALOG NUMBER: 23030819. 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 COMPARISON OF LONG-TERM RESULTS AFTER BAERVELDT 250 IMPLANTATION IN ADVANCED UVEITIC VS. OTHER FORMS OF GLAUCOMA. THIS SINGLE-CENTER RETROSPECTIVE STUDY WAS DONE TO EVALUATE LONG-TERM RESULTS FOLLOWING A BAERVELDT 250 IMPLANTATION IN HIGHLY COMPLEX AND SURGICALLY BURDENED UVEITIC GLAUCOMA EYES (UG) AND COMPARE TO A SIMILAR POPULATION SUFFERING FROM OTHER FORMS OF GLAUCOMA (OFG). A TOTAL OF 62 EYES WERE INCLUDED, GROUPED INTO UG (N=24 EYES) GROUP AND OFG (N=38 EYES) GROUP. THE BAEVELDT IMPLANT, BG103-250 (ABBOTT MEDICAL OPTICS INC., SANTA ANA, CA, USA) WAS SECURED USING TWO DAFILON 6¿0 SUTURES. PATENCY WAS ENSURED THROUGH IRRIGATION, AND TUBE OCCLUSION WAS PERFORMED USING A VICRYL RAPIDE 6¿0 SUTURE TO PREVENT POST-OPERATIVE HYPOTONY. A SCLERAL FLAP WAS PREPARED AND THE TUBE WAS INSERTED USING A 23-GAUGE NEEDLE FOR TRACKING. THE TUBE WAS ATTACHED TO THE GLOBE USING NYLON 10¿0 SUTURES AND THE SCLERAL FLAP WAS SECURED, AND CONJUNCTIVA CLOSED USING VICRYL 7¿0 SUTURES. POST-OPERATIVE COMPLICATIONS INCLUDED: HYPOTENSION (< 5 MMHG): UG (N=25%); OFG (N=18.42%). REVISION DUE TO HYPOTONY: UG (N=50%); OFG (N=71.43%). ENDOTHELIAL-TOUCH DUE TO HYPOTONY: OFG (N=42.86%). INFLAMMATION: UG (N=4.17%). DIPLOPIA: UG (N=4.17%); OFG (N=5.26%). EXPULSIVE HEMORRHAGE: OFG (N=2.63%). RETINAL DETACHMENT: UG (N=4.17%). HYPERTENSION: OFG (N=5.26%). UG GROUP HAD MOSTLY TRANSIENT VISUAL ACUITY DECREASING EVENTS, WHILE THE OFG GROUP SUFFERED A MORE LASTING DAMAGE IN PART DUE TO CORNEAL DEFICITS NECESSITATING CORNEAL TRANSPLANTATION (PENETRATING KERATOPLASTY OR DESCEMET MEMBRANE ENDOTHELIAL KERATOPLASTY, DMEK). THE OFG GROUP (N=31.25% ) REQUIRED RE-TRANSPLANTATION. OF THESE, PENETRATING KERATOPLASTY (N=4 EYES) AND DME KERATOPLASTY (N=1 EYE) WERE DONE. THERE WERE NO FURTHER INTERVENTIONS REPORTED. OTHER JNJ PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2844935 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG103-250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention