MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN

Catalog Number UNKNOWN

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

Patient Problem Difficulty Chewing (2670)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

Esw prosthesis, esophageal, esq.This event has been reported by the manufacturer under mdr#3001845648-2019-00728 - (b)(4).

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 low profile, proximal flare shape (choostent; mi tech, pyeongtaek, korea).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, watertown, mass], evolution [wilson cook medical, letchworth, uk], hanarostent [mi tech], or endoflex [voerde, germany]).As initially reported to customer relations via emailed article from cook europe: as per lit review: most ae's were minor and included 4 cases of food impaction after stent placement.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9473667
• MDR Text Key: 181757696
• Report Number: 3005580113-2019-00904
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2019
• Distributor Facility Aware Date: 12/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2019
• 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