MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS BAERVELDT SHUNT; IMPLANT, EYE VALVE

Model Number BG103-250

Device Problems Complete Blockage (1094); Device Dislodged or Dislocated (2923)

Patient Problems Corneal Abrasion (1789); Macular Edema (1822); Corneal Stromal Edema (1824); Eye Injury (1845); Hyphema (1911); Keratitis (1944); Visual Impairment (2138); Loss of Vision (2139); Eye Infections (4466); Eye Pain (4467); Intraocular Pressure Decreased (4468); Unspecified Tissue Injury (4559); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: 63.1 (11.2).Sex/gender: 13 (59.1%) males and 9 (40.9%) females; not specified if grouped with johnson & johnson implant.Weight: unknown/not provided.Race: 9 (40.9%) black, 11 (50.0%) white, 2 (9.1%) other; not specified if grouped with johnson & johnson implant.Ethnicity: 6 (27.3%) hispanic or latino, 16 (72.7%) not hispanic or latino.Date of event: as there is no article date listed on this study, the "last update posted" date from clinicaltrials.Gov is being used, which is (b)(6) 2021.Serial number: unknown/not provided.Expiration date: unknown, as the serial number was not provided.Unique identifier (udi) number: unknown, as the serial number was not provided.If implanted, give date: unknown/not provided.If explanted, give date: unknown/not provided.Device manufacture date: unknown, as the serial number was not provided.The device was not returned for analysis.There was no serial number reported for this device; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.(b)(4).Feldman, r.The american glaucoma society (ags) second aqueous shunt implant vs.Transscleral cyclophotocoagulation treatment study (assists).Clinicaltrials.Gov identifier: (b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on a literature review: article: the american glaucoma society (ags) second aqueous shunt implant vs.Transscleral cyclophotocoagulation treatment study (assists).A randomized interventional study was done to compare outcomes of patients with uncontrolled glaucoma with a single existing aqueous tube shunt implant undergoing a second aqueous shunt to transscleral diode laser cyclophotocoagulation (tlc).A total of 42 eyes of the 50 enrolled eyes received the assigned intervention and were grouped into second aqueous shunt (sas) group (n= 22 eyes) and transscleral cyclophotocoagulation (tlc) group (n=20 eyes).However, only 12 eyes (n=7 eyes and n=5 eyes, respectively) completed the study.For the sas group, either a baerveldt glaucoma implant 350-mm2 bg101-350 or an ahmed model fp7 flexible plate was used unless there is insufficient space, wherein a baerveldt glaucoma implant 250-mm2 bg103-250 was used.Transscleral diode laser cyclophotocoagulation was used with the tlc group.Serious adverse events included: hyphema (n=1 eye); central nervous system (cns) syphilis causing pan uveitis (n=1 eye); and death (n=3), but cause of death were not reported.Other reported events were: choroidals (n=1), corneal epithelial defect (n=1), decreased visual acuity (n=2), development of cystoid, macular edema (n=1), diabetic macular edema (n=1), ectropion (n=1), filamentary keratitis (n=1), herpes simplex virus dendritic keratitis (n=1), hyphema (n=1), hypotony of eye (n=1), overfiltration of eye (n=1), re-exposed tube (n=1), superior nasal tube with <1 mm exposure at limbus (original tube) (n=1), trabectome/goniotomy of eye (n=1), tube migration anteriorly (n=1), vision loss from count fingers to light perception(n=1), vitreous clogging of second tube shunt (n=1), leak/inflammation or infection of eye (n=1), incidence of pain ¿ 12 participants (57.1%).It was not clear whether these complications occurred in eyes with the baerveldt shunt or the other competitor product.There were no indications in the article of any interventions provided.This report is for model bg103-250 adverse events.A separate report is being submitted to capture the reported product problems for this model.Additionally, a separate report is being submitted for model bg101-350.

• Brand Name: BAERVELDT SHUNT
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15029802
• MDR Text Key: 295991362
• Report Number: 3012236936-2022-01888
• Device Sequence Number: 1
• Product Code: KYF
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BG103-250
• Device Catalogue Number: BG103-250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other