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

Model Number UNKNOWN

Device Problems Complete Blockage (1094); Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Macular Edema (1822); Corneal Stromal Edema (1824); Eye Injury (1845); Hyphema (1911); Intraocular Pressure Increased (1937); Visual Impairment (2138); Intraocular Pressure Decreased (4468)

Event Type  malfunction  

Event Description

Article: outcomes of the second aqueous shunt implant versus transscleral cyclophotocoagulation treatment study: a randomized comparative trial.A study was done to compare the implantation of a second glaucoma drainage device (sgdd) and transscleral cyclophotocoagulation (cpc) in eyes with inadequately controlled intraocular pressure (iop), despite the presence of a pre-existing glaucoma drainage device.A total of 50 patients were enrolled and 5 were excluded.Only 45 were randomized, but 3 had withdrawn before undergoing the assigned surgical procedure.Thus, 42 patients were included and underwent the assigned study procedure: sgdd (n=22 eyes) and cpc (n=20 eyes).A baerveldt 350-mm2 (model bg101-350) was utilized as the sgdd in 16 (n=16, 73%) participants, a baerveldt 250-mm2 (model bg101-250) in 4 (n=4, 18%) participants, and an ahmed fp-7 glaucoma valve (new world medical, rancho cucamonga, ca) in 2 (n=2, 9%) participants.Complications included failures (n=4) in the sgdd group: 2 were due to inadequate iop reduction on maximally tolerated medications (n=2), where a patient went on to receive cpc (n=1).One failed on implantation of a third gdd (n=1) and on receiving an additional cpc (n=1) due to iop being above the clinically determined target.After 12 months, there was additional failure (n=1) in the sgdd group.There was also =0.2 logmar deterioration in best-corrected visual acuity (bcva) from baseline (n=3, 14%) in the sgdd group.Other complications included: hyphema (n=2); choroidal effusion (n=1).Cystoid/diabetic macular edema progression (n=2).Primary tube complications- (n= 2).Ectropion (n=1).Second tube migration anteriorly (n=1).Vitreous occluding sgdd (n=1).Persistent hypotony (n=2), which lasted beyond 3 months or required surgical intervention; one resolved by month 6, with a reduction of iop-lowering medications and the other had drainage of an associated choroidal effusion (n=1) which resolved the hypotony.Other ocular procedures included: third gdd (n=1) 10 months after the sgdd was implanted; cpc (n=2).Vitrectomy (n=1).Anterior chamber washout (n=1).Corneal debridement (n=1).Second tube reposition (n=1).Repair of exposed primary gdd (n=1).Repair of exposed sgdd (n=1).Ectropion repair (n=1).These events were for the sgdd group; it is unclear however, if it was our device or the other device in the group that was implanted in the affected eyes.There were no further interventions reported.A copy of the article is provided with this report.There were two models reported.This report is for model bg101-350 and bg103-250 product problem.A separate report is being submitted to capture the reported adverse event for these models.

Manufacturer Narrative

Section a, patient information: a2, a4, a5: information unknown/asku.Section b3 date of event: (b)(6) 2022.As the event date is not available, the month and year of the article was provided.Section d4 model and catalog number: unknown as it¿s unclear which device model contributed to the reported serious injuries and malfunctions.Section d4 expiration date: unknown as the serial number was not provided.Section d4 unique identifier (udi) number: a partial udi was provided as the serial number is not available.Section d6a, if implanted, give date: unknown/not provided.Section d6b, if explanted, give date: unknown/not provided.Section h4 device manufacture date: unknown as the serial number was not provided.Section h3-other (81): the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Section h6- health effect - impact code: 4625 used to capture glaucoma drainage device (gdd), cyclophotocoagulation (cpc), vitrectomy, anterior chamber washout, second tube reposition, repair of exposed primary glaucoma drainage device, repair of secondary glaucoma drainage device (sgdd) and ectropion repair.Section h6- health effect - clinical code: 4468 used to capture hypotony persistent, code 1937 used to capture increased intraocular pressure and 1845 used to capture vitreous occluding.Section h6- medical device problem code: 3191 used to capture device failure.Feldman, r.M.; chuang, a.Z.; mansberger, s.L.; tanna, a.P.; blieden, l.S.; bell, n.P.; gross, r.L.; pasquale, l.R.; greenfield, d.S.; liebmann, j.M.; weinreb, r.N.; the assists group.Outcomes of the second aqueous shunt implant versus transscleral cyclophotocoagulation treatment study: a randomized comparative trial.Journal of glaucoma 31(9):p 701-709, september 2022.Doi: 10.1097/ijg.0000000000002079.Attempts will be made to obtain the missing information.To date, no additional information has been received.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: 17243754
• MDR Text Key: 318655876
• Report Number: 3012236936-2023-01660
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue 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: 06/01/2023
• 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