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 Problem Dysphagia/ Odynophagia (1815)

Event Date 06/19/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength ¿ = 2360 g/m all others.The following information was requested, but unavailable: does the author/ surgeon believe that ethicon products (vicryl plus suture) involved caused and/or contributed to post-op complications (anastomotic stricture/ dysphagia (n=2)) described in the article? please specify.Does the author/ surgeon believe there was any deficiency with the ethicon products (vicryl plus suture) used for cases described in this study? if yes, please provide a complete patient demographics for patients with post-op complication (anastomotic stricture/ dysphagia)? were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.No additional information can be provided.Please clarify what exactly type of stratafix suture was used in this study.No additional information can be provided.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.Related event captured via 2210968-2021-08906.Citation: journal of thoracic disease (2021);13(7):4349-4359.Doi: 10.21037/jtd-21-438.

Event Description

Title: pretreatment-assisted robot intrathoracic layered anastomosis: our exploration in ivor-lewis esophagectomy.The aim of this retrospective study is to report our early experience in miile using prila and describe the technical innovations made in response to intraoperative challenges.A total of 43 patients (33 males and 10 females; mean age of 62.60±7.135 years; mean bmi of 21.9±2.45) underwent minimal invasive ivor-lewis esophagectomy (miile) using the series technique called pretreatment-assisted robot intrathoracic layered anastomosis (prila) with curative intent for a biopsy proved esophageal malignancy between september 2018 and december 2020.A 4 cm-wide gastric conduit was constructed using a linear stapler (ec60g, j&j, usa).Suturing of the posterior esophageal muscular layer and the posterior seromuscular layer of the conduit using a 3-0 barbed suture (stratafix, j&j co., usa), the posterior esophageal mucosa and the posterior mucosa of the conduit with 4/0 vicryl plus antibacterial suture (j&j co., usa), the anterior mucosa with another 4/0 vicryl plus antibacterial suture, and the anterior muscular layer with another 3-0 barbed suture (stratafix, j&j co., usa).Reported complications include anastomotic stricture/ dysphagia (n=2), by placing the duodenal feeding tube and one endoscopic balloon dilatation, the patients gradually returned to normal diet.In conclusion, the series technique of prila further streamlines and visualizes the process of intrathoracic ega, thus ensuring the precise anastomosis, which would be a feasible alternative for intrathoracic ega in miile.

• 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: 12918979
• MDR Text Key: 285627048
• Report Number: 2210968-2021-12296
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• 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: 11/12/2021
• 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