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 Decompensation (1790); Hyphema (1911); Retinal Detachment (2047); Vitreous Hemorrhage (2143); Intraocular Pressure Decreased (4468)

Event Type  Injury  

Event Description

The following article was received based on a literature review: article: surgical outcomes of glaucoma drainage device implantation in refractory glaucoma patients in thailand a retrospective study was done to study the surgical outcomes of glaucoma drainage device (gdd) implantation in refractory glaucoma patients.A total of 144 eyes of 134 patients were included in the study and were divided into two groups: the primary glaucoma group included 57 eyes from 49 patients while the secondary glaucoma group included 87 eyes from 85 patients.The glaucoma patients underwent gdd implantation using either ahmed glaucoma valve (n=79 eyes) (agv; new world medical, inc), baerveldt glaucoma implants 250 (n=19 eyes), baerveldt glaucoma implants 350 (n=30 eyes), (bgi; abbott medical optics), aurolab aqueous drainage implantation 250 (n=4 eyes) or aurolab aqueous drainage implantation 350 (n=12 eyes) (aadi; aurolab).At year 1 follow up, 5 eyes were classified as failure in the primary glaucoma group while 9 eyes were classified as failure in the secondary glaucoma group.At year 2 follow up, 4 eyes were classified as failure in the secondary glaucoma group.At year 3 follow up, 1 eye was classified as failure in the primary glaucoma group and at year 4 follow up, 1 eye was classified as failure in the secondary glaucoma group.Failure is qualified as intraocular pressure (iop) below 6 mmhg or higher than 21 mmhg even with antiglaucoma medication and loss of light perception of vision.The complications and adverse events reported in patients implanted with a non-valved gdd include the following: (n=4 eyes) corneal decompensation (n=4 eyes) tube malposition/exposure/occlusion (n=3 eyes) hypotony (n=4 eyes) hyphema/vitreous hemorrhage (n=1 eye) rhegmatogenous retinal detachment further laser and surgery include the following: (n=1 eye) penetrating keratoplasty (n=7 eyes) reposition tube (n=1 eye) scleral patch (n=1 eye) amniotic membrane patch (n=8 eyes) vitrectomy (n=2 eyes) tube ligation (n=5 eyes) anterior chamber irrigation (n=5 eyes) second gdd (n=1 eye) trabeculectomy (n=3 eyes) needling gdd (n=1 eye) selective laser trabeculoplasty (n=4 eyes) micropulse laser/transcleral cyclophotocoagulation it is not clear if these complications occurred in the eyes implanted with baerveldt glaucoma implants 250, 350 (abbott medical optics), or the other products.A copy of the article is provided with this report.

Manufacturer Narrative

Section a2: age/date of birth (months): ages are 55.6 ± 14.2 (primary glaucoma); 52.8 ± 14.2 (secondary glaucoma) section a3: sex/gender: (male: female): 28:21 (primary glaucoma); 58:27 (secondary glaucoma) section a4 & a5: information unknown, not provided.Section b3: date of event: exact dates not provided, article acceptance date is december 6, 2022 section d4: a complete catalog number is unknown as the serial number was not provided.Section d4: :lot number: unknown, information not provided.Section d4: expiration date: unknown, as the lot number was not provided.Section d4: udi number: unknown, as the lot number was not provided.Section d6a: implant date : unknown, information not provided.Section d6b: explant date : unknown, information not provided.Section h3-other (81): the device was not returned for analysis.The serial 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.Section h4: device manufacture date: unknown, as the serial number was not provided.Citation: kulawan rojananuangnit, prangkhwan jiaranaisilawong, onvipa rattanaphaithun, wanwisa sathim, surgical outcomes of glaucoma drainage device implantation in refractory glaucoma patients in thailand, (2022), clinical ophthalmology; 2022:16 : page 4163¿4178 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 17251845
• MDR Text Key: 318439426
• Report Number: 3012236936-2023-01608
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K905129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BG103-250
• Device Catalogue Number: BG103-250
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2023
• 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): Required Intervention