MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Citation: neurosurgery.2000; 46 (6): pp 1391 ¿ 1396.(b)(4).

Event Description

It was reported via journal article: title: "dural repair using acellular human dermis: experience with 200 cases: technique assessment," authors: warren, w.Lee m.D.; medary, max b.M.D.; dureza, catalino d.M.D.; bellote, j.Brad m.D.; flannagan, patrick p.M.D.; oh, michael y.M.D.; fukushima, takanori m.D.Citation: neurosurgery.2000; 46 (6): pp 1391 ¿ 1396.The authors performed 200 craniotomies using an acellular human dermal graft to determine the suitability of the device as a dural substitute.The goal in using a dural substitute is to achieve a watertight closure, to prevent infection, and to provide a surface along which the body can generate neodura.From june 1996 through march 1998, all patients at the allegheny general hospital who required a dural substitute graft and in whom autograft harvest was impractical or impossible received acellular dermal autograft.During the surgical procedure, after the dural substitute is inserted, a running nurolon 4-0 suture (ethicon) was used to secure it to the dura or cranium.Reported complications included superficial wound infection (n-4) which required subsequent surgery, post-operative csf leaks (n-3) in which did not resolved with lumbar drain placement.These patients returned to the operating room for exploration; 2 underwent craniotomy and 1 patient underwent endoscopic transnasal exploration, and a (b)(6) caucasian man with csf leak with no response to lumbar drainage and returned to the operating room for an endoscopic exploration.The authors have gained considerable experience with the acellular human dermis.The material behaves very much like dura in situ, in that it does not induce adhesion formation or rejection.It was concluded that the device is a safe, cost-effective material, with obvious advantages over other dural substitute products.It has demonstrated clinical efficacy, with no apparent risks of transmission, inflammation, or rejection.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE
• 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: 8091733
• MDR Text Key: 128031859
• Report Number: 2210968-2018-77264
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR