MAUDE Adverse Event Report: ETHICON INC. NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 05/28/2020

Event Type  Injury  

Event Description

Title: outcome of a low-cost glaucoma drainage device with posterior chamber/pars plana insertion of the tube.This study present the results of posterior chamber/pars plana implantation of the aadi with a modified technique that has the potential to prevent peritubular leak.A retrospective chart review of all patients who had undergone aadi implantation (with insertion of tube in the sulcus/posterior segment) between june 2015 and november 2018 was done.Patients were asked to stop anti­ glaucoma medications on the 40th post-operative day.The implant was then sutured to the sclera with 9-0 monofilament nylon sutures(ethicon) at 8 mm from the limbus for the inferonasal quad­ rant and at 10 mm from the limbus for other quadrants.The sutures were rotated to bury the knots.Priming of the aadi was done by injecting balanced salt solution into the tube through a 27 g cannula.The tube was then ligated close to the plate by using 6-0 vicryl sutures (ethicon) and ligation confirmed by injecting saline again.Reported complications included patient no.5 73 years old developed exposure of the tube 9 months after surgery (inferonasal implantation).It was noted that the scleral patch graft had rotated sideward.The patient was taken to the operating room and under surgical asepsis, the conjunctiva over the exposed tube was incised and a fresh scleral patch graft placed to cover the tube.It was noted that the old graft still had two 10--0 nylon sutures on one edge.Patient no.11 59 years old presented with eye pain and was noted to have vitreous blocking the tube with an iop of 42 mmhg on the 40th post-operative day.He was treated with pars plana vitrectomy and clearing of tube in the operating room.Postoperatively the iop was noted to be 12 mmhg.In conclusion aadi implantation results in a substantial drop in iop.However, many patients continue to require anti­ glaucoma medications.Allowing overlap of scleral/comeal patch graft onto the scleral flap may be effective in preventing peritubular leak.It may be advisable to use 9--0 nylon sutures to secure the scleral patch graft anti-glaucoma medications can be temporarily suspended after the 40th post-operative day to minimize hypotony related complications.Melting of the scleral patch graft may be an early sign of endophthal rnitis.It would be prudent to specifically look for ocular motility problems in patients undergoing aadi implantation.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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.(b)(4).Related events reported via 2210968-2022-05634, 2210968-2022-05635, and 2210968-2022-05636.Citation cite: eye (2021) 35:901-912 https://doi.Org/10.1038/s41433-020-0994-x.

• Brand Name: NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15051314
• MDR Text Key: 296128793
• Report Number: 2210968-2022-05633
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/19/2022
• 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
• Patient Age: 73 YR