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  malfunction  

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.

Manufacturer Narrative

Pma/510(k) # k163468.Cancellation report is being submitted due to the receipt of confirmation from our medical officer that the ae¿s were related to the surgical procedure as opposed stent placement.The event no longer meets the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ based on medical advisor input stating that the device did not cause or contribute to the occlusions and sepsis and no device malfunction has been identified.

Event Description

Cancellation report is being submitted due to the receipt of confirmation from our medical officer that the ae¿s were related to surgical procedure as opposed stent placement.The event no longer meets the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ based on medical advisor input stating that the device did not cause or contribute to the occlusions and sepsis and no device malfunction has been identified.

• 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,Followup
• Report Date: 04/22/2024

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 05/21/2024
• 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