BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 5644186 · Received May 10, 2016

    Report

    Report Number
    9614546-2016-00216
    Event Type
    Injury
    Date Received
    May 10, 2016
    Report Date
    September 19, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE BAERVELDT SHUNT(S) WERE NOT RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION; THEREFORE A PRODUCT INVESTIGATION WAS NOT POSSIBLE. THE REPORTED EVENTS COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS THE SERIAL NUMBERS FOR THE BAERVELDT SHUNTS ARE UNKNOWN. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. THE DFU INCLUDES A SECTION ON COMPLICATIONS/ADVERSE EVENTS DURING AND AFTER SURGERY. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENTS COULD NOT BE CONFIRMED AND THERE WAS NO INDICATION OR A PRODUCT DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A RETROSPECTIVE COMPARISON OF PRIMARY BAERVELDT IMPLANTATION VERSUS TRABECULECTOMY WITH MITOMYCIN C LITERATURE WAS REVIEWED. AUTHOR (S): JOSEPH F. PANARELLI, MD,1 MICHAEL R. BANITT, MD, MHA, STEVEN J. GEDDE, MD, WEI SHI, MS, JOYCE C. SCHIFFMAN, MS, WILLIAM J. FEUER, MS PUBLICATION: OPHTHALMOLOGY 2016;123:789-795 2016 BY THE AMERICAN ACADEMY OF OPHTHALMOLOGY. ORIGINALLY RECEIVED: JULY 25, 2015. FINAL REVISION: NOVEMBER 5, 2015. ACCEPTED: NOVEMBER 12, 2015. PURPOSE: TO COMPARE THE SAFETY AND EFFICACY OF BAERVELDT IMPLANTATION (ABBOTT MEDICAL OPTICS, (B)(4)) AND TRABECULECTOMY WITH MITOMYCIN C (MMC) IN PATIENTS WHO HAVE NOT UNDERGONE PRIOR INCISIONAL OCULAR SURGERY. DESIGN: RETROSPECTIVE, COMPARATIVE CASE SERIES. PARTICIPANTS: A TOTAL OF 125 PATIENTS WITH LOW-RISK GLAUCOMA UNDERGOING PRIMARY GLAUCOMA SURGERY, INCLUDING 55 PATIENTS WHO RECEIVED A 350-MM2 BAERVELDT GLAUCOMA IMPLANT AND 70 PATIENTS WHO UNDERWENT TRABECULECTOMY WITH MMC. RESULTS: THE CUMULATIVE PROBABILITY OF SUCCESS AT 3 YEARS WITH OR WITHOUT MEDICAL THERAPY WAS 87% IN THE BAERVELDT GROUP AND 76% IN THE TRABECULECTOMY GROUP (P=0.23). POSTOPERATIVE COMPLICATIONS OCCURRED IN 11 PATIENTS (20%) IN THE BAERVELDT GROUP AND 20 PATIENTS (29%) IN THE TRABECULECTOMY GROUP (P=0.27). MEAN FOLLOW-UP STANDARD DEVIATION WAS 27-19 MONTHS IN THE BAERVELDT GROUP AND 34-20 MONTHS IN THE TRABECULECTOMY GROUP (P=0.053). THE MOST COMMON CAUSE FOR FAILURE IN BOTH TREATMENT GROUPS WAS INADEQUATE IOP REDUCTION (IOP >21 MMHG OR <20% REDUCTION BELOW BASELINE AT 2 CONSECUTIVE FOLLOW-UP VISITS AFTER 3 MONTHS). THERE WERE 5 PATIENTS IN THE BAERVELDT GROUP AND 6 IN THE TRABECULECTOMY GROUP WHOSE TREATMENT FAILED BECAUSE OF INADEQUATE IOP REDUCTION. TREATMENT FAILURE RESULTING FROM PERSISTENT HYPOTONY WAS NOT OBSERVED IN THE BAERVELDT GROUP, BUT OCCURRED IN 4 PATIENTS IN THE TRABECULECTOMY GROUP. ALL PATIENTS WHOSE TREATMENT FAILED BECAUSE OF PERSISTENT HYPOTONY HAD A DECREASE IN VA FROM BASELINE. MEAN FOLLOW-UP STANDARD DEVIATION WAS 27-19 MONTHS IN THE BAERVELDT GROUP AND 34-20 MONTHS IN THE TRABECULECTOMY GROUP (P=0.053). A TOTAL OF 7 PATIENTS IN THE TRABECULECTOMY GROUP UNDERWENT REOPERATIONS FOR GLAUCOMA, INCLUDING 2 TRABECULECTOMY REVISIONS AND 6 TUBE SHUNT IMPLANTATIONS (1 PATIENT UNDERWENT BOTH PROCEDURES). IN THE BAERVELDT GROUP, 2 PATIENTS UNDERWENT ADDITIONAL GLAUCOMA SURGERY INVOLVING PLACEMENT OF A SECOND BAERVELDT IMPLANT IN BOTH CASES. NO SIGNIFICANT DIFFERENCE IN THE RATE OF REOPERATION FOR GLAUCOMA WAS OBSERVED BETWEEN THE 2 TREATMENT GROUPS (P=0.30). SNELLEN VA DECREASED BY 2 OR MORE LINES FROM BASELINE IN 18 PATIENTS (33%) IN THE BAERVELDT GROUP AND IN 28 PATIENTS (40%) IN THE TRABECULECTOMY GROUP AT LAST FOLLOW-UP (P=0.40). A TOTAL OF 11 COMPLICATIONS IN 55 PATIENTS (20%) WERE REPORTED IN THE BAERVELDT GROUP, AND 20 COMPLICATIONS IN 70 PATIENTS (29%) WERE NOTED IN THE TRABECULECTOMY GROUP (P=0.27). COMPLICATIONS EMERGING AT LEAST 1 MONTH AFTER SURGERY INCLUDED PERSISTENT CORNEAL EDEMA, BLEB LEAK, PERSISTENT DIPLOPIA, AND ENDOPHTHALMITIS OR BLEBITIS. CHOROIDAL EFFUSION, WOUND LEAK, AND MALIGNANT GLAUCOMA WERE OBSERVED IN THE EARLY POSTOPERATIVE PERIOD. WOUND LEAK OCCURRED WITH SIGNIFICANTLY GREATER FREQUENCY IN THE TRABECULECTOMY GROUP THAN IN THE BAERVELDT GROUP (P=0.006). THREE PATIENTS (5.5%) IN THE BAERVELDT GROUP AND 7 PATIENTS (10%) IN THE TRABECULECTOMY GROUP EXPERIENCED SURGICAL COMPLICATIONS THAT REQUIRED A REOPERATION TO MANAGE THE COMPLICATION (P=0.24). SIXTEEN PATIENTS (29%) IN THE TUBE GROUP AND 23 PATIENTS (33%) IN THE TRABECULECTOMY GROUP UNDERWENT CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION (P=0.65). A TREND TOWARD A HIGHER INCIDENCE OF DIPLOPIA AND PERSISTENT CORNEAL EDEMA WERE NOTED AFTER BAERVELDT IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298295 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention