MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 45MM ARTICNG LNR CUTR/WHT RLD; STAPLE, IMPLANTABLE

Catalog Number	ATW45
Health Effect - Clinical Codes	Sepsis (2067); Perforation of Esophagus (2399); Obstruction/Occlusion (2422)
Date of Event	01/01/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Publication year of 2008.Batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.(b)(4).
Event or Problem Description
It was reported via literature entitled: use of temporary esophageal stent in management of perforations after benign esophageal surgery.Author: fumiaki yano, md, amr el sherif, md, charles j.Filipi, md, and sumeet k.Mittal, md citation: surg laparosc endosc percutan tech (2008);18:283¿285.The authors reported a series of 3 patients with non anastomotic postsurgical esophageal leak successfully treated by temporary esophageal stent.(patient 2) a (b)(6) year old male patient was referred for recurrent episodes of iron deficiency anemia with hemoglobin as low as 2 g/dl in which the only identifiable cause for recurrent anemia was a large incarcerated hiatus hernia.The patient underwent a transthoracic collis-nissen procedure in which a 3-cm collis gastroplasty was performed with a gastrointestinal anastomosis stapler (endo gia, atw 45, ethicon) with a 46-fr bougie placed in the esophagus.Reported complications included mid esophageal leak, persistent sepsis, and air leak in the mediastinum well above the collis segment in which 2 mediastinal drains were placed through the hiatus and brought out through the anterior abdominal wall and a feeding jejunostomy and gastrostomy tube was also placed and the patient had immediate resolution of the sepsis, and distal obstruction owing to the collis-nissen fundoplication and esophageal perforation in which an esophageal stent was placed across the perforation and fundoplication protruding 3 cm into the stomach.Post stent placement, a contrast study showed no extravasation and the patient was discharged on a mechanical soft diet.In conclusion, the placement of removable silicone-covered self-expanding polyester stents seems to be a successful minimally invasive treatment option for postoperative esophageal leaks after nonresectional surgery.

• Brand Name: 45MM ARTICNG LNR CUTR/WHT RLD
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8917608
• Report Number: 3005075853-2019-20934
• Device Sequence Number: 1746681
• Product Code: GDW
• UDI-Device Identifier: 10705036001096
• UDI-Public: 10705036001096
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ATW45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention