MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS BAERVELDT SHUNT; SURGICAL ADJUNCTS

Model Number BG103-250

Device Problems Occlusion Within Device (1423); Appropriate Term/Code Not Available (3191)

Patient Problems Retinal Detachment (2047); Vitrectomy (2643); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event - (b)(6) 2017.Udi # unknown was listed, since serial number of the device was not provided.Serial - unknown/not provided.Expiration date - is unknown since serial number of the device was not provided.Implant date - unknown, not provided.Explant date - unknown, not provided.Mfg date - unknown since serial number of the device was not provided.(b)(4).Journal citation: vinod k, panarelli jf, gentile rc, sidoti pa.Long-term outcomes and complications of pars plana baerveldt implantation in children.Journal of glaucoma.26(3)(2017):266-271.All pertinent information available to abbott medical optics has been submitted.

Event Description

From the glaucoma journal: long-term outcomes and complications of pars plana baerveldt implantation in children abstract: purpose of the study: the purpose of the study was to report long-term outcomes and complications of baerveldt glaucoma implant (bgi) surgery with pars plana tube insertion in children.Materials and methods: the medical records of consecutive aphakic and pseudophakic children (<16 y of age) who underwent bgi surgery with pars plana tube insertion between 1990 and 2013 were retrospectively reviewed.Main outcome measures were intraocular pressure and number of glaucoma medications.Postoperative complications were recorded.Failure was defined as an intraocular pressure <5 or >/=21 mm hg (with or without glaucoma medications), loss of light perception, or need for additional glaucoma surgery.Results: thirty-seven children were identified with a mean age of 6.0+/-4.7 years (range, 4 mo to 14.5 y).Mean follow-up after pars plana bgi surgery was 6.5+/-3.4 years (range, 9 mo to 12.8 y) for patients who met success criteria.Mean intraocular pressure and mean number of glaucoma medications at most recent follow-up for patients with successful intraocular pressure control were 13.8+/-4.1 and 2.3+/-1.9 mm hg, respectively.The kaplan-meier survival analysis revealed 1-, 3-, 5-, and 7-year success rates of 94.5%, 74.6%, 65.0%, and 45.8%, respectively.Complications included tube exposure in 1 patient (2.7%), tube obstruction in 8 patients (21.6%), and retinal detachment in 9 patients (24.3%).Seventeen patients (45.9%) failed due to inadequate intraocular pressure control, of whom 9 (24.3%) required additional glaucoma surgery.Conclusions: although pars plana bgi surgery is a reasonable option for managing refractory glaucoma in aphakic and pseudophakic children, surgeons must be aware of the potential need for additional glaucoma surgery and/or posterior segment complications with extended follow-up.One patient developed chronic hypotony due to a fixed funnel retinal detachment that was deemed inoperable.Complications requiring reoperation occurred in 18 patients, and included tube exposure in 1 patient, tube obstruction in 8 patients, and retinal detachment in 9 patients.One patient had a ruptured globe 14 months after pars plana baerveldt glaucoma implant (ppbgi), and required conjunctivoplasty for tube exposure 1 month after ruptured globe repair.Eight patients developed tube obstruction.Vitreous incarceration within the proximal tube lumen occurred in 7 patients, 6 of whom required additional pars plana vitrectomy.The last had spontaneous resolution of tube obstruction and iop normalized without surgery.One patient developed tube obstruction by iris 7 months postoperatively, requiring surgical revision.All 8 patients regained successful iop control after resolution of obstruction.

Manufacturer Narrative

Device evaluation: the device was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing record cannot be reviewed since the serial number is unknown.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: BAERVELDT SHUNT
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6739024
• MDR Text Key: 80865703
• Report Number: 9614546-2017-00662
• Device Sequence Number: 1
• Product Code: KYF
• UDI-Public: (01)
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: BG103-250
• Device Catalogue Number: 23030819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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