MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Catalog Number UNKNOWN

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

Patient Problems Sepsis (2067); Obstruction/Occlusion (2422)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

Pma 510k #k163468.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Console 2016 ¿ colonic acute malignant obstructions: effectiveness of self-expanding metallic stent as bridge to surgery in bg (62 patients), an endoscopic stent insertion was performed in all cases (table 4); covered stents were placed in 4 (6.4%) cases, and the most commonly used was the nitinol type.All patients in bg taking anticoagulant drugs shifted to lmwh.9 cases of occlusion and 7 cases of sepsis requiring intervention require intervention/additional procedures s=4.Inclusion criteria were the emergency presentation of occlusion symptoms (less than 72 hours), an american society of anesthesiologists (asa) physical status of =3, and age of >50 years.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18452701
• MDR Text Key: 332261284
• Report Number: 3001845648-2024-00016
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 10/17/2016
• Event Location: Hospital
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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