MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT; SUTURE, ABSORBABLE, SYNTHETIC

Device Problem Material Erosion (1214)

Patient Problems Eye Injury (1845); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Corneal decompensation, conjunctival erosion, surgical intervention.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that any deficiency of the ethicon product vicryl suture caused and/or contributed to the adverse events described in the article? citation: can jophthalmol (2017) vol.52,n0.1, 85-91; doi: http://dx.Doi.Org/10.1016/j.Jcjo.2016.06.007.

Event Description

It was reported in a journal article title: graft-free ahmed valve implantation through a 6mm scleral tunnel.The purpose of this retrospective cohort study was to evaluate the safety, efficacy, and cost savings of ahmed glaucoma valve (agv) tube implantation through a 6-mm scleral tunnel (graft-free techniques).Between dec2010 and jun2013, 84 eyes from 62 patients (n=27 male, n=35 female; mean age sd 71±16 years) underwent graft-free agv implantation for the treatment of medically uncontrolled elevated intraocular pressure (iop).During the procedure, the conjunctiva was moved forward to cover the plate and a portion of the tube and then sutured to the underlying sclera and surrounding conjunctiva with 7-0 vicryl sutures.6-0 vicryl was utilized as bridle suture.Postoperatively, complications included hyphema (n=15) and corneal decompensation (n=4).After 2-year follow-up, conjunctival erosion (n=2) was noted.Four eyes who had corneal decompensation required agv tube trimming for tube corneal touch; 3 eyes resolved, but 1 eye had persistent corneal decompensation.Our data suggest that the safety and efficacy ofa6mm st is comparable with conventional scleral graft method.Additional information has been requested.

Manufacturer Narrative

Therefore this medwatch report is not reportable.Additional information was requested and the following was obtained: does the surgeon believe that any deficiency of the ethicon product vicryl suture caused and/or contributed to the adverse events described in the article? i am here confirming there is no adverse effect reported in my study due to the use of ethicon suture.

• Brand Name: VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7372202
• MDR Text Key: 103516191
• Report Number: 2210968-2018-71668
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K022269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2018
• 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