BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 8895653 · Received August 14, 2019

    Report

    Report Number
    9614546-2019-00732
    Event Type
    Injury
    Date Received
    August 14, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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. SEX/GENDER: UNKNOWN. DATE OF EVENT: UNKNOWN. EXPIRATION DATE: UNKNOWN. SERIAL NUMBER: UNKNOWN. UDI NUMBER: UNKNOWN. IF IMPLANTED; GIVE DATE: UNKNOWN. IF EXPLANTED; GIVE DATE: NOT APPLICABLE, THERE IS NO INDICATION THE DEVICES HAVE BEEN EXPLANTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT/SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). MURAKAMI, Y., AKIL, H., CHAHAL, J., DUSTIN, L., TAN, J., CHOPRA, V., FRANCIS, B. (2016). ENDOSCOPIC CYCLOPHOTOCOAGULATION VERSUS SECOND GLAUCOMA DRAINAGE DEVICE AFTER PRIOR AQUEOUS TUBE SHUNT SURGERY. CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY 45(1), PP. 2441-246. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE "ENDOSCOPIC CYCLOPHOTOCOAGULATION VERSUS SECOND GLAUCOMA DRAINAGE DEVICE AFTER PRIOR AQUEOUS TUBE SHUNT SURGERY" LITERATURE WAS REVIEWED. AUTHORS: YOHKO MURAKAMI, HANDAN AKIL, JASDEEP CHAHAL, LAURIE DUSTIN, JAMES TAN, VIKAS CHOPRA, AND BRIAN FRANCIS. PUBLICATION: 24 MAY 2016. CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY (2017) 45: 241-246. PATIENTS WITH REFRACTORY GLAUCOMA FOLLOWING A FAILED INITIAL TUBE SHUNT (BAERVELDT GLAUCOMA IMPLANT 350), WHO UNDERWENT ENDOSCOPIC CYCLO-PHOTOCOAGULATION (ECP) OR SECOND GLAUCOMA DRAINAGE DEVICE (GDD-2) WITH BAERVELDT GLAUCOMA IMPLANT AS A SECOND SURGERY. TWENTY-FIVE EYES UNDERWENT ECP, AND 48 EYES RECEIVED A GDD-2. BOTH ECP AND GDD-2 SIGNIFICANTLY LOWERED IOP (STUDENT'S T TEST) AND NUMBER OF ANTIGLAUCOMA MEDICATIONS (WILCOXON PAIRED SIGNED RANK TEST). THERE WERE NO SIGNIFICANT DIFFERENCES IN POSTOPERATIVE IOP (STUDENT'S T TEST) OR ANTIGLAUCOMA MEDICATIONS (MANN WHITNEY TEST) BETWEEN ECP AND GDD-2 AT 6 AND 12 MONTHS. THERE WAS ALSO NO DIFFERENCE IN THE KAPLAN¿MEIER SURVIVAL OUTCOMES BETWEEN THE TWO GROUPS. SEVENTY-THREE PATIENTS WERE INCLUDED IN THE STUDY; 25 UNDERWENT ECP AND 48 HAD GDD-2 (26 BAERVELDT 250, 22 BAERVELDT 350). ONLY ONE EYE OF EACH PATIENT WAS INCLUDED. THERE WERE NO STATISTICAL DIFFERENCES NOTED BETWEEN THE GROUPS WITH RESPECT TO MEAN AGE AT THE TIME OF SURGERY, GENDER, MEAN PREOPERATIVE IOP, CUP-TO-DISC RATIO, MD ON VISUAL FIELDS, PSD ON VISUAL FIELDS AND PREOPERATIVE BEST CORRECTED VA. POSTOPERATIVE IOP WAS SIGNIFICANTLY LOWER THAN PREOPERATIVE IOP FOR BOTH ECP AND GDD-2 AT ALL TIME POINTS FOR BOTH ECP AND GDD-2 GROUPS (P < 0.05 FOR ALL TIME POINTS). THERE WAS NO SIGNIFICANT DIFFERENCE IN IOP BETWEEN ECP AND GDD-2 AT 6 MONTHS (T-VALUE 0.0494, P > 0.5) AND 12 MONTHS (T-VALUE 0.4924, P > 0.5). THE MEDIAN NUMBER OF IOP LOWERING MEDICATION WAS 3 IN THE ECP GROUP AND 4 IN GDD-2 GROUP. THERE WAS NO SIGNIFICANT DIFFERENCE IN NUMBER OF ANTIGLAUCOMA DROPS USED BETWEEN ECP AND GDD-2 AT 6 MONTHS (T-VALUE 1.5807, P > 0.5) AND 12 MONTHS (T-VALUE 0.0674, P > 0.5). BOTH GROUPS EXPERIENCED A DECREASE IN THE NUMBER OF MEDICATIONS NECESSARY TO ACHIEVE ADEQUATE IOP AFTER THE SURGERY; THIS EFFECT LASTED THROUGHOUT THE 2-YEAR FOLLOW-UP. FAILURES OCCURRED IN BOTH GROUPS BECAUSE OF INADEQUATE PRESSURE CONTROL OR INCREASED ANTIGLAUCOMA MEDICATIONS. COMPLICATIONS, WHICH WERE HYPOTONY, CORNEAL EDEMA, HIGH IOP, INFLAMMATION AND CYSTOID MACULAR EDEMA, WERE SEEN IN BOTH GROUPS AND DID NOT SHOW ANY STATISTICALLY SIGNIFICANT DIFFERENCE (P > 0.05). IN THE ECP GROUP, SEVEN OF THE 25 EYES EVENTUALLY FAILED, FOUR ACCORDING TO OUR IOP FAILURE CRITERIA AND THREE BECAUSE OF INCREASED MEDICATIONS FOLLOWING SURGERY. IN THE GDD-2 GROUP, 22 OF 48 EYES EVENTUALLY FAILED, NINE BECAUSE OF HIGH PRESSURE, NINE BECAUSE OF INCREASED MEDICATIONS AND ONE BECAUSE OF HYPOTONY. NO EYES PROGRESSED TO LOSS OF LP IN EITHER GROUP. CUMULATIVE SUCCESS FOR ECP AND GDD-2 THROUGHOUT THE LAST FOLLOW-UP AT 24 MONTH DID NOT REACH STATISTICALLY SIGNIFICANT DIFFERENCE (LOG-RANK TEST, P = 0.12; BRESLOW GENERALIZED WILCOXON, P = 0.09). WHEN SELECTING A SURGICAL TREATMENT MODALITY TO CONTROL IOP AFTER CLINICAL FAILURE OF A PRIOR AQUEOUS TUBE SHUNT, THE RISK OF POSTOPERATIVE COMPLICATIONS AND LONG-TERM EFFICACY OF THE SECOND SURGERY MUST BE CONSIDERED CAREFULLY. THEORETICALLY, THE ADDITION OF A PROCEDURE THAT DECREASES AQUEOUS INFLOW TO AN EXISTING PROCEDURE THAT INCREASES AQUEOUS OUTFLOW SHOULD RESULT IN SUCCESSFUL REDUCTION OF IOP AND ANTIGLAUCOMA MEDICATIONS. FRANCIS ET AL. 11 DEMONSTRATED THE EFFICACY AND SAFETY OF ECP IN THE TREATMENT OF REFRACTORY GLAUCOMA WITH A PRIOR AQUEOUS TUBE SHUNT. USING A SUCCESS DEFINITION OF IOP REDUCTION = 3 MMHG OR A REDUCTION IN ANTIGLAUCOMA MEDICATIONS IN THE MEDICATION-INTOLERANT GROUP WITH IOP = 21 MMHG, THEY REPORTED A CUMULATIVE SUCCESS RATE OF 88% AT 6 MONTHS, WHICH REMAINED AT THIS LEVEL AT LAST FOLLOW-UP OF 2 YEARS. IN OUR STUDY OF REFRACTORY GLAUCOMA WITH A PRIOR AQUEOUS TUBE SHUNT, BOTH ECP AND GDD-2 SUCCESS-FULLY LOWERED IOP AND NUMBER OF ANTIGLAUCOMA MEDICATIONS AS A SECOND SURGERY. THE GDD-2 GROUP INCLUDED BOTH 250 AND 350 SIZES OF BAERVELDT GLAUCOMA IMPLANTS. OF NOTE, CUMULATIVE SUCCESS WAS HIGHER FOR ECP THAN GDD-2 THROUGHOUT LAST FOLLOW-UP AT 24 MONTHS. THIS DIFFERENCE SHOWED A SLIGHT TREND TOWARD SIGNI?CANCE BUT DID NOT REACH STATISTICAL SIGNI?CANCE (LOG-RANK TEST, P = 0.12; BRESLOW GENERALIZED WILCOXON, P = 0.09), PERHAPS AS A RESULT OF THE SMALLER SAMPLE SIZE OF ECP PATIENTS COMPARED TO GDD-2. A WEAKNESS OF THIS STUDY IS THAT NO SAMPLE SIZE POWER CALCULATION WAS MADE BECAUSE OF THE RETROSPECTIVE DESIGN. THE CLINICAL SIGNIFICANCE OF THIS TREND IN OUR SERIES BEARS FURTHER STUDY IN A PROSPECTIVE MANNER. OUR STUDY SUPPORTS THE EFFICACY AND SAFETY OF BOTH ECP AND GDD-2 IMPLANTATION AS A SECOND SURGERY IN EYES WITH REFRACTORY GLAUCOMA WITH A PRIOR AQUEOUS TUBE SHUNT. BOTH OPTIONS SHOULD BE CONSIDERED FOR PATIENTS REQUIRING A SECOND INTERVENTION, WITH CAREFUL ATTENTION TO THE POTENTIAL POSTOPERATIVE COMPLICATIONS CAUSED BY EACH IN THESE PATIENTS WITH MULTIPLE PRIOR SURGERIES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685769 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF JOHNSON & JOHNSON SURGICAL VISION, INC. BG103-250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention