BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 10506000 · Received September 9, 2020

    Report

    Report Number
    9614546-2020-00389
    Event Type
    Injury
    Date Received
    September 9, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL NUMBER: UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THERE IS NO INDICATION THE DEVICE WAS EXPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. (B)(4). THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT IS UNKNOWN IF LENS REMAINS IMPLANTED OR IF EXPLANTED. ALSO, NO SPECIFIC PRODUCT IDENTIFIERS WERE PROVIDED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ARTICLE: LONG-TERM SAFETY AND EFFICACY OF CONJUNCTIVAL PEDICLE GRAFT REVISION COMBINED WITH REPEATED PERICARDIUM ALLOGRAFT FOR EXPOSED GLAUCOMA DRAINAGE DEVICES. CITATION: JOSÉ M. GUAJARDO, MSC, MD AND KIN S. LIM, MB, CHB, MD. RECEIVED FOR PUBLICATION MARCH 1, 2018; ACCEPTED AUGUST 9, 2018. FROM THE GLAUCOMA SERVICE, DEPARTMENT OF OPHTHALMOLOGY, ST THOMAS¿ HOSPITAL, GUY¿S AND ST THOMAS¿ NHS FOUNDATION TRUST, LONDON, UK. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: LONG-TERM SAFETY AND EFFICACY OF CONJUNCTIVAL PEDICLE GRAFT REVISION COMBINED WITH REPEATED PERICARDIUM ALLOGRAFT FOR EXPOSED GLAUCOMA DRAINAGE DEVICES. A RETROSPECTIVE NONCOMPARATIVE CASE STUDY WAS DONE TO INVESTIGATE THE SAFETY AND LONG-TERM RESULTS OF CONJUNCTIVAL PEDICLE GRAFT (CPG) TECHNIQUE FOR REVISION OF EXPOSED GLAUCOMA DRAINAGE DEVICE (GDD). TUBE EXPOSURE OCCURRED IN SEVEN (7) PATIENTS ON BAERVELDT TUBE (N=5 ON BAERVELDT 350 MM AND N=2 ON BAERVELDT 250 MM). ALL PATIENTS UNDERWENT REVISION BY CONJUNCTIVAL PEDICLE GRAFT (CPG) TECHNIQUE AS INTERVENTION. ONE (1) PATIENT ON BAERVELDT 350 MM DEVELOPED TUBE RE-EXPOSURE AFTER REVISION VIA CPG TECHNIQUE (N=1). THIS FILE CAPTURES SUSPECT BAERVELDT SHUNT WITH MODEL NUMBER BG103-250. ANOTHER FILE IS SUBMITTED TO CAPTURE BAERVELDT SHUNT WITH UNKNOWN 350 MODEL NUMBER. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975359 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG103-250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention