BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 3497851 · Received December 3, 2013

    Report

    Report Number
    2020664-2013-00108
    Event Type
    Injury
    Date Received
    December 3, 2013
    Report Date
    November 6, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    BECAUSE THE SERIAL NUMBERS WERE NOT IDENTIFIED, IT IS NOT POSSIBLE TO DETERMINE THE MANUFACTURING AND EXPIRATION DATES OF THE SHUNTS. EVENT PROBLEM CODES: THE LITERATURE ARTICLE PROVIDES INFORMATION ON MULTIPLE PATIENTS AND MULTIPLE EVENTS WITH NO SPECIFIC PATIENT IDENTIFIERS. THE AUTHOR HAS BEEN CONTACTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE DATA HAS NOT BEEN RECEIVED. THEREFORE, THE EVENT PROBLEM CODE FIELD IS NOT FILLED OUT AT THE TIME OF SENDING THIS REPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING LITERATURE ARTICLE IS BEING REPORTED AS A MEDICAL DEVICE REPORT (MDR). THE SPECIFIC MODEL NUMBERS, SERIAL NUMBERS, PATIENT IDENTIFIERS (GENDER, AGE), EVENT DETAILS WERE NOT PROVIDED. HENCE THIS REPORT IS BEING SUBMITTED AS ONE INDIVIDUAL MEDWATCH REPORT. THE AUTHOR HAS BEEN CONTACTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN RECEIVED AT THE TIME OF SENDING THIS REPORT. AHMED VERSUS BAERVELDT STUDY SUMMARY ¿THE AHMED VERSUS BAERVELDT STUDY: THREE-YEAR TREATMENT OUTCOMES¿: AUTHOR: CHRISTAKIS, PANOS G; TSAI, JAMES C; KALENAK, JEFFREY W; ZURAKOWSKI, DAVID; CANTOR, LOUIS B; KAMMER, JEFFREY A; AHMED, IQBAL I K PUBLICATION INFO: OPHTHALMOLOGY 120.11 (NOV 2013): 2232-40. THE STUDY WAS TO COMPARE TWO COMMONLY USED AQUEOUS DRAINAGE DEVICES FOR THE TREATMENT OF REFRACTORY GLAUCOMA. ELIGIBLE PATIENTS WERE RANDOMIZED TO AN AHMED ¿FP7 VALVE IMPLANT OR A BAERVELDT-350 IMPLANT (ABBOTT MEDICAL OPTICS, INC, SANTA ANA CA). A TOTAL OF 238 PATIENTS WERE ENROLLED AND RANDOMIZED OF THOSE 124 RECEIVED AHMED IMPLANT AND 114 RECEIVED THE BAERVELDT IMPLANT. BASELINE DEMOGRAPHICS AND OCULAR CHARACTERISTICS WERE SIMILAR IN BOTH GROUPS. DISEASE GLAUCOMA WAS REFRACTORY TO MAXIMUM TOLERATED MEDICAL THERAPY, WITH A MEAN INCREASED INTRAOCULAR PRESSURE (IOP) OF 31.4 + OR - 10.8 MMHG. HALF THE STUDY POPULATION HAD SECONDARY GLAUCOMA, 21% HAD NEOVASCULAR GLAUCOMA AND 10% HAD UVEITIC GLAUCOMA. MANY PATIENTS HAD FAILED LASER AND SURGICAL THERAPY, 25% HAD PREVIOUSLY UNDERGONE LASER TRABECULOPLASTY AND 37% HAD FAILED TRABECULOPLASTY WITH ANTIMETABOLITE. BASELINE VISION WAS POOR WITH MEDIAN SNELLEN ACUITY OF 20/100. ALL PATIENTS RECEIVED THE IMPLANT TO WHICH THEY WERE RANDOMIZED. THE PRIMARY AND SECONDARY OUTCOMES WERE MEASURED IN THOSE GROUPS. PRIMARY OUTCOME WAS FAILURE, DEFINED AS INTRAOCULAR PRESSURE (IOP) OUTSIDE OF THE TARGET RANGE (5-18 MMHG) VISION THREATENING COMPLICATIONS, DE NOVO GLAUCOMA PROCEDURES, OR LOSS OF LIGHT PERCEPTION. SECONDARY OUTCOME MEASURES INCLUDED IOP, MEDICATION USE, VISUAL ACUITY, COMPLICATIONS, AND INTERVENTIONS. THE 2 GROUP HAD HAD SIMILAR COMPLICATIONS RATES HOWEVER BAERVELDT GROUP HAD A HIGHER RATE OF HYPOTONY-RELATED VISION THREATENING COMPLICATIONS THAT REQUIRED MORE INTERVENTIONS. TREATMENT OUTCOMES: AFTER 3 YEARS OF FOLLOW UP, FAILURE OCCURRED IN 63 PATIENTS OUT OF WHICH 39 PATIENTS BELONGED TO THE BAERVELDT GROUP. INTRAOCULAR PRESSURE: WITH 1 TO 2 WEEKS OF FOLLOW UP SEVEN PATIENTS IN THE BAERVELDT GROUP HAD VISION¿THREATENING HYPOTONY-RELATED COMPLICATIONS (3 DEVELOPED SUPRACHOROIDAL HAEMORRHAGE, 3 HAD RETINAL/CHOROIDAL DETACHMENTS AND 1 HAD REFRACTORY HYPOTONY REQUIRING EXPLANTATION). GLAUCOMA MEDICATION USE: AT THE 3-YEAR VISIT 50% OF THE BAERVELDT GROUP REQUIRED NO MEDICATION USE. DE NOVO GLAUCOMA PROCEDURES: DE NOVO GLAUCOMA SURGERY WAS REQUIRED IN 7 PATIENTS IN THE BAERVELDT GROUP. CYCLODESTRUCTION WAS PERFORMED IN 2 PATIENTS FROM THE BAERVELDT GROUP. A GOLD MICRO SHUNT (SOLX LTD, BOSTON MA) WAS PLACED IN 3 PATIENTS IN THE BAERVELDT GROUP. AN AHMED DEVICE WAS IMPLANTED IN 1 PATIENT IN THE BAERVELDT GROUP. POSTOPERATIVE COMPLICATIONS: IN THE FIRST 3 YEARS AFTER SURGERY 71 PATIENTS IN THE BAERVELDT GROUP EXPERIENCED COMPLICATIONS. SHALLOW ANTERIOR CHAMBER IN (19), CHOROIDAL EFFUSION (16), PERSISTENT IRITIS (11), PERSISTENT CORNEAL EDEMA IN (16), ENCAPSULATED BLEB (3), TUBE COMPLICATIONS (18), CATARACT PROGRESSION (10), MOTILITY DISORDER (3), PERSISTENT HYPHAEMA (6), NO LIGHT PERCEPTION (6), MALIGNANT GLAUCOMA(2), SUPRACHOROIDAL HAEMORRHAGE (3), RETINAL CHOROIDAL DETACHMENT (3). POSTOPERATIVE INTERVENTIONS: IN THE FIRST 3 YEARS AFTER SURGERY 57 PATIENTS IN THE BAERVELDT GROUP REQUIRED INTERVENTIONS. THE MOST COMMON INTERVENTIONS INCLUDED ANTERIOR CHAMBER REFORMATION(14), PARACENTESIS (16), PHACOEMULSIFICATION (10), TUBE INTERVENTIONS (16), BLEB NEEDLING (4), PARS PLANA VITRECTOMY (5), IRIS SWEEP (4), LASER PERIPHERAL IRIDOTOMY (2), DESCEMET STRIPPING ENDOTHELIAL KERATOPLASTY (DSEK)/ PENETRATING KERATOPLASTY (5), YAG CAPSULOTOMY (3), DRAINAGE OF SUPRACHOROIDAL HAEMORRHAGE (2), ADDITIONAL GLAUCOMA SURGERY (7), EXPLANT OR ENUCLEATION (3). THE MAJORITY OF THE COMPLICATIONS AND INTERVENTIONS OCCURRED DURING THE FIRST 3 MONTHS OF THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624533 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention