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

Model Number UNKNOWN

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

Patient Problems Macular Edema (1822); Corneal Stromal Edema (1824); Eye Injury (1845); Hemorrhage/Bleeding (1888); Hyphema (1911); Intraocular Infection (1933); Visual Impairment (2138); Loss of Vision (2139); Eye Infections (4466); Intraocular Pressure Decreased (4468)

Event Date 10/22/2022

Event Type  Injury  

Manufacturer Narrative

Section a2: age/date of birth: mean age was 63.1 (standard deviation (sd):12.5) years old; not specified if grouped with johnson & johnson implant.Section a3: sex/gender: 20 (56%) males; not specified if grouped with johnson & johnson implant.Section a4 patient weight: unknown; requested but not provided.Section a5: race/ethnicity: 13 (36%) white, 17 (47%) black, 5 (14%) hispanic, 1 (3%) asian; not specified if grouped with johnson & johnson implant.Section b3: date of event: (b)(6) 2022 (date article was e-published).Section d4: model number: unknown; requested but not provided.Section d4: catalog number: unknown, as the serial number was not provided.Section d4: serial number: unknown; requested but not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: unique identifier (udi) number: unknown, as the serial number was not provided.Section d6a: if implanted, give date: unknown; requested but not provided.Section d6b: if explanted, give date: not applicable, as there was no indication the device was explanted.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.To, l.K., dhoot, r.K., chuang, a.Z., karimaghaei, s., guevara-abadia, f., shah, r.D., feldman, r.M.Defining the role of ab externo xen gel stent in glaucomatous eyes with prior failed surgical intervention.Graefe's archive for clinical and experimental ophthalmology.2023 mar;261(3):779-789.Doi: 10.1007/s00417-022-05857-6.Epub 2022 (b)(6).Attempts were made to obtain additional information was conducted, however there is no additional information available.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: defining the role of ab externo xen gel stent in glaucomatous eyes with prior failed surgical intervention.A retrospective, single-center, case¿control study was done to evaluate the safety and efficacy of xen45 gel stent (xen; allergan) in eyes that have failed prior surgical intervention, compared to traditional glaucoma drainage device (gdd) or continuous-wave cyclophotocoagulation (cpc).A total of 18 case (xen) eyes and 36 control eyes were included in the study.Among the 36 control eyes, 25 eyes underwent gdd implantation (n=24 eyes with baerveldt [johnson & johnson], n=1 eye ahmed fp7 [new world medical]) and 11 trans-scleral continuous wave cpc.It was reported that 7 control eyes failed within the follow-up period due to requiring additional glaucoma surgery and 1 control eye that failed due to loss of light perception.Of the 7 control eyes which required additional glaucoma surgery, 6 eyes underwent cpc (2 of which had additional gdd removal) and 1 had gdd removal with no additional glaucoma procedures due to infection.In the control group, a minor complication of hyphema (n=4 eyes) was reported while serious complications reported include tube/xen exposure (n=2 eyes), blebitis (n=1 eye), cystoid macular edema (n=2 eyes), choroidal effusion (n=2 eyes), and hemorrhagic choroidal detachment (n=1 eye).There were 7 incidences of early hypotony and 4 eyes reported with a permanent loss of 2 lines or more of best corrected visual acuity (bcva) in the control group.All revisions in the control group were performed on gdds and were either due to iris plugging the tube (n=2 eyes) or tube malposition (n=2).The eyes with tube/xen exposure (n=2 eyes) and blebitis (n=1 eye) required tube explantation, as did 1 eye which had a malpositioned tube.It is not clear if these complications occurred in the eyes implanted with baerveldt or the other product.A copy of the article is provided with this report.This report is for the reported adverse events.A separate report is being submitted to capture the reported product problems.

• Brand Name: UNK_GLAUCOMA SHUNT_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: 17269666
• MDR Text Key: 318546654
• Report Number: 3012236936-2023-01722
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955455
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK-GLAUCOMA SHUNT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• 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