MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

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

Patient Problem Regurgitation (2259)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

The 510(k) number could be k162717 or k093619, however as the rpn has not been provided it cannot be confirmed.The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusion.Facility details: department of gastroenterology, endoscopy division (1), department of gastroenterology, surgery division (2), cancer institute of the university of (b)(6).

Event Description

Adverse events of self-expandable esophageal metallic stents in patients with long-term survival from advanced malignant disease.Medeiros 2017.For lesions located in the proximal esophagus, we used a dedicated model of a partially covered stent with a lowprofile, proximal flare shape (choostent; (b)(4)).For lesions located in the mid-esophagus, we used a standard partially covered stent or, less often, a fully covered stent, with an 18- to 23-mm body diameter and 23- to 28-mm flare diameter (wallflex and ultraflex [boston scientific, (b)(4)], evolution [wilson cook medical, (b)(4)], hanarostent [(b)(4)], or endoflex [(b)(4)]).Severe gastroesophageal reflux (heart burn or regurgitation associated with the findings of peptic erosions at endoscopy) - 1 case.''restenting was performed for 1 patients for due severe reflux.'' cannot confirm that an evo-pc/fc-e (unknown) was used -file being opened conservatively.

Manufacturer Narrative

The 510(k) number could be k162717 or k093619, however as the rpn has not been provided it cannot be confirmed.This report is being submitted as a cancellation report.The literature review confirms that a cook stent was not used for the case of reflux.

Event Description

This report is being submitted as a cancellation report.The literature review confirms that a cook stent was not used for the case of reflux.

• Brand Name: UNKNOWN
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9472774
• MDR Text Key: 188806283
• Report Number: 3001845648-2019-00732
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/15/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention