BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 15018555 · Received July 14, 2022

    Report

    Report Number
    3012236936-2022-01863
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    October 5, 2021
    Report Date
    June 18, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K905129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 OCT 5, 2021. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. CATALOG NUMBER: THE COMPLETE CATALOG NUMBER IS 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: EXACT DATE NOT PROVIDED. ONLY PROVIDED AS FEBRUARY 2018. 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: MITSUI N., SUGIHARA K., SEGUCHI J., CHIHARA E., MORIZANE Y., NARITA A. (2021). CORYNEBACTERIUM OCULAR INFECTION AFTER BAERVELDT GLAUCOMA IMPLANT SURGERY: TREATMENT INVOLVING IMMEDIATE TUBE WITHDRAWAL AND TEMPORARY SUBCONJUNCTIVAL TUBE PLACEMENT: A CASE REPORT. BMC OPHTHALMOL. 21(1):368; PP.1-6. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN THE REPORT SUBMITTED JULY 14, 2022 ((B)(4)), AN INCORRECT CATALOG NUMBER WAS INADVERTENTLY SUBMITTED. THIS REPORT CONTAINS THE CORRECTED CATALOG NUMBER. SECTION D4 - CATALOG #: 23030817. 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: CORYNEBACTERIUM OCULAR INFECTION AFTER BAERVELDT GLAUCOMA IMPLANT SURGERY: TREATMENT INVOLVING IMMEDIATE TUBE WITHDRAWAL AND TEMPORARY SUBCONJUNCTIVAL TUBE PLACEMENT: A CASE REPORT. THIS STUDY WAS DONE TO REPORT A PATIENT CASE WITH CORYNEBACTERIUM ENDOPHTHALMITIS SECONDARY TO TUBE EXPOSURE FOLLOWING BAERVELDT GLAUCOMA IMPLANT SURGERY THAT WAS SUCCESSFULLY TREATED WITH PROMPT TUBE WITHDRAWAL AND TEMPORARY SUBCONJUNCTIVAL TUBE PLACEMENT WITHOUT REMOVING THE GLAUCOMA DRAINAGE DEVICE (GDD). A BAERVELDT GLAUCOMA IMPLANT (BG101¿350, JOHNSON & JOHNSON, (B)(4)) WAS IMPLANTED IN THE INFERONASAL QUADRANT, IN COMBINATION WITH CLEAR CORNEAL PHACOEMULSIFICATION, ASPIRATION AND INTRAOCULAR LENS IMPLANTATION. THE SILICONE TUBE WAS LIGATED NEAR THE PLATE USING 7¿0 VICRYL® (ETHICON INC., (B)(4) USA), AND COVERED WITH A FULL THICKNESS DONOR SCLERAL PATCH GRAFT. TWO VENTING SLITS WERE CREATED USING A 7¿0 VICRYL® NEEDLE. PATIENT HAD INTRAOCULAR PRESSURE (IOP) OF 30 MMHG ON FIVE CLASSES OF GLAUCOMA MEDICATIONS. TEN MONTHS POST-SURGERY, THE TUBE WAS EXPOSED, CONJUNCTIVAL DEHISCENCE AND SCLERAL PATCH GRAFT EROSION WERE OBSERVED. TOPICAL GATIFLOXACIN 0.3% (SENJU PHARMACEUTICAL, (B)(4)) WAS STARTED. ELEVEN DAYS AFTER TUBE EXPOSURE, PATIENT WAS DIAGNOSED WITH INFECTIOUS ENDOPHTHALMITIS SECONDARY TO TUBE EXPOSURE. TWO DAYS AFTER DIAGNOSIS, THE SCLERAL PATCH GRAFT WAS REMOVED, AND THE EXPOSED TUBE AND SURROUNDING AREA WERE STERILIZED USING 0.025% POLYVINYL ALCOHOL-IODINE (PA·IODO OPHTHALMIC AND EYE WASHING SOLUTION, NITTEN PHARMACEUTICAL, (B)(4)) DILUTED WITH SALINE. AQUEOUS HUMOR FROM THE AC SPECIMEN WERE OBTAINED AFTER TUBE REMOVAL FOR CULTURE TESTING. THE REMOVED TUBE AND EXPOSED AREA WERE IRRIGATED WITH THE 0.025% POLYVINYL ALCOHOL-IODINE SOLUTION. THE TUBE ENTRY SITE WAS SUTURED WITH 8¿0 VICRYL® THEN, AC WAS IRRIGATED WITH VANCOMYCIN 20 G/ML (SHIONOGI, (B)(4)) AND CEFTAZIDIME 40 G/ML (GLAXOSMITH-KLINE, (B)(4)). MEDICAL THERAPY INCLUDED TOPICAL CEFMENOXIME 0.5% AND GATIFLOXACIN 0.3%. CULTURE TESTING IDENTIFIED THE GROWTH OF CORYNEBACTERIUM SPECIES THUS, OFLOXACINE OINTMENT 0.3% (SANTEN PHARMACEUTICAL, (B)(4)) APPLICATION WAS ADDED. THE INFECTION COMPLETELY RESOLVED 1.5 MONTHS AFTER TUBE REMOVAL. THEREAFTER, THE TUBE WAS REINSERTED INTO THE AC IN THE SUPERIOR-NASAL DIRECTION AND THE TUBE WAS COVERED WITH A SCLERAL PATCH GRAFT AND A FREE LIMBAL CONJUNCTIVAL AUTOGRAFT. 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
    2062369 BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention