MAUDE Adverse Event Report: ETHICON INC. NUROLON 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 02/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent to fda: 5/3/2023.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 reported via 2210968-2023-03274, 2210968-2023-03275, and 2210968-2023-03277 citation cite: j neurosurg pediatr 28:351¿359, 2021 https://thejns.Org/doi/abs/10.3171/2021.2.Peds20743.

Event Description

Title: long-term clinical and radiographic outcomes after pial pericranial dural revascularization: a hybrid surgical technique for treatment of anterior cerebral territory ischemia in pediatric moyamoya disease the aim of this study was to describe the long-term clinical and radiographic outcomes of a novel approach of pial pericranial dural (piped) revascularization, building on the principles of pial synangiosis but unique in using the pericranium and the dura mater as the primary vascular supply, and employing a larger craniotomy with arachnoid dissection to provide robust full-territory revascularization in all ages with reduced risk relative to more complex procedures.The medical records of all pediatric patients with mmd who presented at a single center between (b)(6) 2009 and (b)(6) 2019 were retrospectively reviewed to identify patients with mmd with anterior cerebral territory ischemia.A total of 25 operations (5.6% of total procedures) were performed in 21 patients (mean age 9.4 years [range 1¿16.5 years]; 12 female and 9 male).Almost one-third of the patients had syndromic associations, with no familial cases.10-0 nylon suture and 4-0 nurolon sutures were used.Reported complications included superficial infection (n=1), long-term follow-up : radiographic engraftment (n=18) , 5-year-old boy presented with radiographic engraftment in conclusion the use of the pericranium and the dura mater for indirect revascularization provided robust vascularized graft with great flexibility in location and high potential for engraftment, which may obviate more complex and higher- risk operations for aca territory ischemia.Long-term follow-up demonstrated that piped revascularization conferred durable, long-term radiographic and clinical protection from stroke in pediatric patients with mmd.Based on the results of the current study, the piped technique can be considered an additional tool to the armamentarium of indirect revascularization procedures in select pediatric patients with mmd.

• Brand Name: NUROLON 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: 16865291
• MDR Text Key: 314524624
• Report Number: 2210968-2023-03276
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• 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: 04/26/2023
• 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 Age: 5 YR
• Patient Sex: Male