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 Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Ischemia Stroke (4418)

Event Date 08/03/2021

Event Type  Injury  

Event Description

Title: diamond-shaped mini-craniotomy: a new concept in neurosurgery the objective of the study is to describe the step by step the modified, less invasive, diamond-shaped mini-craniotomy that optimizes dural opening and can be performed in elderly patients affected by acute subdural or intracerebral hematomas, in therapy with anti-platelets or anticoagulants.This is a retrospectively reviewed the clinical records of 67 patients, 39 males and 28 females, with a mean age of 78.5 years, who were treated in our institution during a period of 10 years (june 2009 - june 2019) with a novel diamond-shaped craniotomy, which is less invasive than standard craniotomy.The dura is closed in a watertight manner using a 4-0 braided nylon suture (ethicon), prolene (ethicon) and sealed with collagen covered with fibrinogen and thrombin and fibrin glue.If the dura cannot be completely closed, a patch is sutured and a dural sealant (evicel®, ethicon, new brunswick, nj, usa) is applied.Reported events includes (n=1) csf leak treatment: surgical intervention, (n=3) cerebral infarction treatment: not mentioned, (n=5) hematoma treatment: not specified.In conclusion, the diamond-shaped craniotomy provides full access and exposure to asdhs and jchs.It represents a safe and effective approach, particularly in elderly patients with a low mortality rate.With increasing experience and availability of micro instruments and optics for working through narrow corridors, this minimally invasive approach is integrated into our daily practice more and more.

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.An attempt has been 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.Citation: j neural surg a cent eur neurosurg 2022;83:236-241.Https://doi.Org/10.1055/s-0041-1730942.Related events captured via 2210968-2024-01849.

• 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: 18773220
• MDR Text Key: 336177846
• Report Number: 2210968-2024-01850
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 02/06/2024
• 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