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

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

Patient Problem Fluid Discharge (2686)

Event Date 06/21/2021

Event Type  Injury  

Event Description

Title: non-intraocular pressure-related revision surgeries after ahmed glaucoma valve (agv) implantation in refractory glaucoma.This retrospective study aims to investigate the causes, types, outcomes and success rates of additional surgical interventions apart from revisions aiming intraocular pressure (iop) control in patients with refractory glaucoma (rg) in a tertiary clinic.Between january 2015 and april 2018, all patients who underwent ahmed glaucoma valve (agv) implantation in the glaucoma clinic of university of health sciences beyoglu eye training and research hospital or in a different clinic, and who underwent surgical revision procedures of ahmed glaucoma valve (agv) were reviewed.Twenty-six eyes of 24 consecutive patients (13 female, 11 male) with mean age of 53.4 ± 24.3 (range 10 to 82) years who underwent various surgical interventions due to complications of agv were included in the study.During surgical revision procedures, in case of tube erosion of 2¿3 mmor less, the conjunctiva was separated and freed from exposed tube itself and then from adjacent conjunctiva and tenon with the help of blunt scissors.A single-layered human pericardial patch graft, same as in our primary agv implantation procedure, was secured to sclera 10¿0 nylon sutures (ethilon black monofilament; ethicon inc., somerville, n.J., usa).If this conjunctival tissue was enough to cover the exposed area over the pericardium, tenon and conjunctiva were primarily sutured with 10¿0 nylon sutures.After all surgical revision procedures, the tenon capsule and the conjunctiva were sutured in separate layers using 8¿0 polyglactin suture (vicryl, ethicon limited, edinburgh, uk).The follow-up time was median 12 (range 6¿92) months after the revision surgery.Reported complications included: (n=1) conjunctiva suturation for wound leak was performed in one eye at the postoperative 2nd week.It was concluded, that ahmed glaucoma valve (agv) implantation has early and late complications; sometimes necessitating additional surgical interventions; which makes it crucial to have longer follow-up for patients with agv implants.Revisional interventions for failed agv implants are efficient procedures for the majority of patients, but recurrence may occur requiring additional surgical revisions.

Manufacturer Narrative

(b)(4).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.Patient demographics? 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).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-05125.Citation: https://doi.Org/10.1007/s10792-021-01920-z.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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: 14933717
• MDR Text Key: 295349869
• Report Number: 2210968-2022-05125
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2022

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: 07/06/2022
• 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