MAUDE Adverse Event Report: ETHICON INC. STRATAFIX UNKNOWN; SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)

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

Patient Problems Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446); Restenosis (4576)

Event Date 03/20/2021

Event Type  Injury  

Event Description

Title: are there benefits in performing gastro-omentopexy in laparoscopic vertical gastrectomy? this study aims to demonstrate the benefits of the gastro-omentopexy technique in patients undergoing sleeve gastrectomy, with possible reduction in postoperative complications.From january to december 2018, 179 patients who underwent sleeve gastrectomy with the laparoscopic gastro-omentopexy technique with follow-up between 6-12 months in the postoperative period were included in the study.Of the included patients, 71.5% were women, with a predominance of the age group between 30-40 years (36.3%).During the procedure, once the stapling process is completed, the fixation of the entire staple line in the gastrocolic and gastrosplenic ligaments begins, using barbed wire stratafix (ethicon).The staple line of the first 5 cm of the proximal portion of the gastric tube is invaginated with continuous suture.Stitches applied to the ligaments are carefully placed in order to avoid vascular damage to the gastro-omental vessels, which pass through the greater curvature of the stomach.Complications include wound infection (n=1.1%), bleeding/hemorrhage (n=0.5%) and stenosis (n=1.1%) in conclusion, the technique promoted a significant improvement in quality of life and control of comorbidities.In addition, it was associated with a low prevalence of stenosis, and with no fistula, making the method safer.

Manufacturer Narrative

(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.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.Citation: abcd arq bras cir dig 2021;34(3):e1598, doi: https://doi.Org/10.1590/0102-672020210003e1598.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral , strength ¿ = 2360 ¿g/m.

• Brand Name: STRATAFIX UNKNOWN
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)
• 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
• MDR Report Key: 14274406
• MDR Text Key: 293695606
• Report Number: 2210968-2022-03227
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: 04/18/2022
• 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