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

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problem Obstruction/Occlusion (2422)

Event Date 09/08/2017

Event Type  Injury  

Event Description

Kit-man ho, 2017 ¿ colonic self-expanding metal stent (sems) as a bridge to surgery in left-sided malignant colonic obstruction: an 8-year review.We used through-the-scope stenting with niti-s uncovered colorectal stents (taewoong medical) in 58 patients, while colonic controlled-release stents (cook medical evolution) were used in the remaining four patients.Under fluoroscopic guidance.Fluoroscopy was available in the endoscopy suite during office hours.The procedure was performed by three colorectal surgeons who were experienced with stenting.A routine abdominal x-ray was taken 24 h after the intervention.Patients who consented to colonic stenting when fluoroscopy was available comprised the stenting group.Clinical success was defined as the resolution of obstructive symptoms within 72 h after the procedure with passage of stool [10].Upon resolution of the intestinal obstruction, patients underwent optimization of their medical condition and thorough oncological workup, including a ct scan of the thorax, abdomen and pelvis if these had not been performed before stenting.One stent dislodgement: stent dislodgement was detected on the post-procedural abdominal x-ray.This patient had persistent symptoms of intestinal obstruction, and he subsequently underwent emergency laparotomy.(1).

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• 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: 18455195
• MDR Text Key: 332263168
• Report Number: 3001845648-2024-00021
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• 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?: Yes
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/08/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male