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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/16/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Van den berg, 2014 ¿ bridge-to-surgery stent placement versus emergency surgery for acute malignant colonic obstruction procedure: the following surgical approaches were used in the surgery-alone group and for patients in the sems group in whom acute operation was warranted (for example in the event of technical failure): resection with primary anastomosis with or without diverting stoma, resection with definitive stoma, decompression stoma aiming at resection in an elective setting, or definitive stoma creation without resection.Following sems placement or stoma formation as a bridge to elective surgery, subsequent elective surgery entailed resection with primary anastomosis.Resection included a routinemesocolic lymphadenectomy, with quality assessment using a cut-off of a median of 12 examined lymph nodes, according to published guidelines 21,22.Patients with resectable synchronous liver metastasis underwent colectomy followed by curative metastasectomy in another operation.There was no strict surgical protocol in the two hospitals for emergency surgery.The choice of specific surgical treatment was at the discretion of the consulting surgeon depending on preoperative and intraoperative findings, tumour location and patient condition.All elective operations were performed by dedicated colorectal surgeons, whereas emergency surgery was undertaken by the surgeon on call.2 cases stent migration (as per table 5) unconfirmed if related to cook stent as multiple devices used in study.

• 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: 18454635
• MDR Text Key: 332260940
• Report Number: 3001845648-2024-00018
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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 Operator: Health Professional
• 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: 04/16/2014
• 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: 71 YR
• Patient Sex: Male