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

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

Patient Problems Hemorrhage/Bleeding (1888); Hyphema (1911); Loss of Vision (2139)

Event Date 08/09/2023

Event Type  Injury  

Event Description

Title: lntraoperative customized reduction in baerveldt implant plate size in elderly patients with glaucoma and short eyes.This pilot study, the first of its type, was conducted to determine the clinical outcome of intraoperative baerveldt implant plate size reduction in elderly patients (>/80 years) with short axial length (<22 mm).Between february 2014 and february 2021, 24 patients who presented with baerveldt 250 mm implantations performed using customized implant plate size reduction surgery were included in the study.There were 3 males and 21 females with a mean age of 83.0 ± 2.9 years.During the procedure, the superior and lateral rectus muscles were isolated, and a non-ethicon 4- 0 silk traction sutures(manufacturer: unknown) placed under the muscles.After verifying the patency of the baerveldt (johnson & johnson vision) implant tube by balanced salt solution irrigation, the tube was occluded near the plate with (2) 6-0 polyglactin 910 (vicryl-rapide, ethicon) ligation sutures placing the knots on the underside of the tube.The custom-made baerveldt implant was secured to the sclera usually 8 mm posterior to the limbus with 8-0 nylon (ethilon, ethicon) sutures and the knots were placed inside the implant plate holes.The conjunctiva was closed using running 9-0 polyglactin (vicryl, ethicon) sutures.Postoperatively, topical dexamethasone drops combined with chloramphenicol were applied for 5 weeks.Reported complications included a female patient who had intraoperative suprachoroidal hemorrhage and postoperative persistent hypotony and loss of light perception vision and classified as a surgical failure (n=1), and postoperative hyphema (n=2).In conclusion, baerveldt implantation with customized plate downsizing can be an effective treatment option for difficult glaucoma in elderly people with short eyes.

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? which specific ethicon products have been used during the procedures (product code, lot number)? 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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2024-00003, 2210968-2024-00004.Citation: juha valimaki (2023) intra operative customized reduction in baerveldt implant plate size in elderly patients with glaucoma and short eyes, clinical ophthalmology, 2287-2293, https://doi.Org/10.2147/opth.S415406.

• Brand Name: ETHILON 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: 18424571
• MDR Text Key: 331858866
• Report Number: 2210968-2024-00005
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2023
• 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): Other
• Patient Sex: Female