BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 5502082 · Received March 15, 2016

    Report

    Report Number
    9614546-2016-00112
    Event Type
    Injury
    Date Received
    March 15, 2016
    Report Date
    March 15, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATES OF BIRTH: UNKNOWN, NOT PROVIDED. GENDER/SEXES: UNKNOWN, NOT PROVIDED. DATES OF EVENT: UNKNOWN, NOT PROVIDED MODEL #'S, CATALOG #'S, SERIAL #'S: UNKNOWN, NOT PROVIDED. EXPIRATION DATES: UNKNOWN, AS SERIAL NUMBERS ARE UNKNOWN. IF IMPLANTED; GIVE DATES: ARTICLE REPORTS IMPLANTS WERE BETWEEN JANUARY 2009 AND JANUARY 2011. IF EXPLANTED; GIVE DATES: NA (NOT APPLICABLE) ARTICLE DOES NOT INDICATE THAT ANY EXPLANTS WERE PERFORMED. (B)(4). DEVICE MANUFACTURE DATES: UNKNOWN, AS SERIAL NUMBERS UNKNOWN, NOT PROVIDED ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE: BAERVELDT TUBE IMPLANTATION FOLLOWING FAILED DEEP SCLERECTOMY VERSUS REPEAT DEEP SCLERECTOMY. BERGIN C, PETROVIC A, MERMOUD A, RAVINET E, SHARKAWI E. GRAEFE'S ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY. 2016;254(1):161-168. PURPOSE: TO COMPARE THE SURGICAL OUTCOMES OF REPEAT DEEP SCLERECTOMY (DS) AND THE BAERVELDT GLAUCOMA IMPLANT (BGI) IN EYES WITH FAILED PRIMARY DEEP SCLERECTOMY. DESIGN A RETROSPECTIVE COMPARATIVE CASE¿CONTROL STUDY. METHODS: FIFTY-EIGHT EYES OF 56 GLAUCOMA PATIENTS WITH PREVIOUSLY FAILED DS UNDERWENT BGI (GROUP BGI) AND 58 EYES OF 55 PATIENTS UNDERWENT REPEAT DS (GROUP DS) AT A TERTIARY REFERRAL CENTRE. VISUAL ACUITY, INTRAOCULAR PRESSURE (IOP), NUMBER OF GLAUCOMA MEDICATIONS, SURGICAL FAILURE RATES AND COMPLICATION RATES WERE COMPARED BETWEEN GROUPS. SURGICAL FAILURE WAS DEFINED AS LOSS OF IOP CONTROL, LOSS OF LIGHT PERCEPTION, OR NEED FOR FURTHER GLAUCOMA SURGERY. RESULTS: BASELINE DEMOGRAPHICS WERE SIMILAR BETWEEN GROUPS. PREOPERATIVELY, MEDIAN IOP WAS LOWER IN THE DS THAN THE BGI GROUP (19 MMHG VERSUS 21 MMHG, P=0.10). POSTOPERATIVELY AT YEAR 1, MEDIAN IOP WAS SIGNIFICANTLY HIGHER IN THE DS THAN BGI GROUP (14 MMHG VERSUS 11 MMHG, P=0.02). THERE WERE NO DIFFERENCES BETWEEN THE DS AND BGI GROUPS IN MEAN NUMBER OF MEDICATIONS PREOPERATIVELY (2.3 VERSUS 2.6) OR POSTOPERATIVELY (1.3 VERSUS 1.1). COMPLICATION RATES WERE SIGNIFICANTLY HIGHER IN THE DS GROUP [41 % (N=24) VERSUS 14 % (N=8); P=0.01]. THE FAILURE RATE AT 1 YEAR WAS HIGHER IN EYES WITH REPEAT DS THAN IN EYES WITH BGI (30 VS. 21 %, RESPECTIVELY; P=0.07). CONCLUSIONS: BAERVELDT IMPLANTS WERE MORE EFFECTIVE IN LOWERING IOP AND RESULTED IN SIGNIFICANTLY FEWER COMPLICATIONS THAN REPEAT DEEP SCLERECTOMY IN EYES WITH PREVIOUSLY FAILED DEEP SCLERECTOMY. PAGE 162: BGI GROUP: ALL EYES UNDERWENT BAERVELDT TUBE (350MM2) SURGERY. ALL SURGERIES WERE PERFORMED BETWEEN JANUARY 2009 AND JANUARY 2011. PAGE 164: COMPLICATIONS: MACROSCOPIC HYPHEMA WAS CONSIDERED PRESENT WHEN GREATER THAN 1MM BLOOD WAS SEEN IN THE AC (ANTERIOR CHAMBER). PERSISTENT HYPOTONY WAS DEFINED AS IOP (INTRAOCULAR PRESSURE) LESS THAN/OR EQUAL TO 5MM HG ON TWO CONSECUTIVE VISITS GREATER THAN OR EQUAL TO 6 WEEKS APART. THE PRESENCE OF CHOROIDAL EFFUSION/HEMORRHAGE AND MACULOPATHY WAS ASSESSED BY ROUTINE DILATED FUNDUS EXAMINATION. RESULTS: BASELINE AND FOLLOW-UP IOP MEASUREMENTS ARE REPORTED. BOTH DS AND BGI LED TO IOP LOWERING, BUT THE IOP PROFILES DIFFERED MARKEDLY BETWEEN GROUPS. DURING THE EARLY POSTOPERATIVE PERIOD, A LARGER IOP REDUCTION WAS OBSERVED IN THE DS GROUP, DAY ONE MEDIAN 9MMHG VERSUS 19 MMHG. AT WEEK ONE (1), IOP IN 13 EYES (22%) FROM THE DS GROUP FELL WITHIN THE HYPOTONY RANGE (LESS THAN/EQUAL TO 5 MMHG), VERSUS ONE EYE (2%) FROM THE BGI GROUP. CONVERSELY, THE BGI GROUP, IOP IN 14 EYES (24%) FELL WITHIN THE HYPERTONY RANGE (GREATER THAN/EQUAL TO 21MM HG), VERSUS ONE EYE (2%) FROM THE DS GROUP. THESE SIGNIFICANT DIFFERENCES IN EARLY POSTOPERATIVE IOP BETWEEN GROUPS PERSISTED UNTIL WEEK 6. AS THE MAJORITY OF THE OCCLUSIVE STENT REMOVAL WAS PERFORMED (BGI GROUP) BETWEEN 6 WEEKS AND 6 MONTHS POSTOPERATIVELY, A LARGE REDUCTION IN MEDIAN IOP WAS OBSERVED IN THE BGI GROUP AT 3 AND 6 MONTHS. AT 12 MONTHS, THE MEDIAN IOP IN THE BGI GROUP WAS SIGNIFICANTLY LOWER THAN THAT IN THE DS GROUP. FIVE EYES IN THE BGI GROUP FAILED DUE TO INSUFFICIENT IOP CONTROL (LESS THAN 20% REDUCTION). AT YEAR 1, FAILURE WAS ESTIMATED AT 21% IN THE BGI GROUP. NONE OF THE EYES IN THE BGI GROUP UNDERWENT REOPERATION DURING THE FIRST YEAR. PAGE 165: IN THE BGI GROUP, THREE COMPLICATIONS WERE RELATED TO HYPOTONY, (THREE CASES OF CHOROIDAL EFFUSION), AND THREE WERE TUBE RELATED (ONE CONJUNCTIVAL EROSION, ONE TUBE RETRACTION, ONE TUBE WITH TIP DAMAGE). THERE WAS ONE CASE OF HYPHEMA AND ONE CASE OF DESCEMET'S MEMBRANE DETACHMENT; THE LATTER WAS TREATED SUCCESSFULLY WITH ANTERIOR CHAMBER GAS INJECTION AT THE SLIT LAMP. OF THE EIGHT EYES WITH COMPLICATIONS, THREE REQUIRED TREATMENT IN THE OPERATING ROOM (THREE TUBE RELATED COMPLICATIONS). NONE OF THE EYES UNDERGOING BAERVELDT SHUNT IMPLANTATION REQUIRED FURTHER GLAUCOMA SURGERY DURING THE FIRST YEAR OF FOLLOW-UP. POSTOPERATIVE INTERVENTIONS: IN THE BGI GROUP, LIGATURE SUTURE LYSIS WITH AN ARGON LASER WAS REQUIRED IN 13 OF THE 18 EYES IN WHICH LIGATION HAD BEEN PERFORMED. ALL EYES HAD OCCLUDING INTRALUMINAL STENTS TO PREVENT HYPOTONY. PAGE 166: ONE EYE IN THE BGI GROUP REQUIRED VISCOELASTIC INJECTION AT THE SLIT LAMP AND ONE EYE REQUIRED BLEB NEEDLING. THE IOP REDUCTION IN THE BGI GROUP CONTINUED UP TO 6 MONTHS POSTOPERATIVELY, COINCIDING WITH THE REMOVAL OF FLOW RESTRICTORS (OCCLUSIVE STENTS). BY 12 MONTHS, MEDIAN IOP WAS SIGNIFICANTLY LOWER IN THE BGI GROUP. A COMMON DEFINITION OF SURGICAL FAILURE IS A REDUCTION IN IOP OF LESS THAN 20% FROM BASELINE OR OUTSIDE THE RANGE OF 5 TO 21 MMHG. USING THIS CRITERION, A LOWER RATE OF SURGICAL FAILURE WAS OBSERVED IN THE BGI GROUP. COMPLICATIONS IN BOTH GROUPS WERE USUALLY TRANSIENT AND DID NOT RESULT IN PERMANENT VISION LOSS. PAGE 166, CONTINUED TO PAGE 167: IN RECENT MULTICENTER TRIALS, COMPLICATION RATES FOR THE BAERVELDT TUBE IMPLANTATION WERE HIGHER THAN THOSE REPORTED HERE; HOWEVER, APPROXIMATELY HALF OF THE REPORTED COMPLICATIONS WERE HYPOTONY-RELATED. IN THE PRESENT REPORT, THE BGI SHUNT IMPLANTATION TECHNIQUE AND POSTOPERATIVE MANAGEMENT WERE SPECIFICALLY MODIFIED TO REDUCE POSTOPERATIVE HYPOTONY-RELATED COMPLICATIONS. IN THE PRESENT REPORT, VISUAL ACUITY REMAINED STABLE DURING THE FIRST YEAR. MOST PATIENTS IN THE BGI GROUP WERE PSEUDOPHAKIC AT THE TIME OF SURGERY. CONCLUSION: EYES WITH BAERVELDT SHUNT IMPLANTS EXPERIENCED A GREATER REDUCTION IN IOP AND FEWER COMPLICATIONS AT 1 YEAR POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157988 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R