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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2022

Event Type  malfunction  

Event Description

Zhang et al 2022 - safety and feasibility of neoadjuvant chemotherapy as a surgical bridge for acute left-sided malignant colorectal obstruction: a retrospective study.Depending on the location of obstructive lesion and presence of edematous bowels, left colectomy, anterior resection, low anterior resection, subtotal colectomy, abdominoperineal resection, and hartmann operation were performed by well-experienced colorectal surgeons in our single center.All sems placements were performed by well-experienced endoscopists using a wallflex colonic stent (boston scientific) or evolution colonic stent (cook ireland limited).The placement of sems includes interventional placement and endoscopic placement.For interventional placement, the patient was placed on the dsa operating bed supine, the perineum was routinely sterilized and draped, a 5f-dav catheter was placed through the anus, and the catheter-guided angiography showed the site of lesion obstruction, and a guide wire was inserted through the catheter.After reaching the distal end, transcatheter angiography showed obvious expansion and gas accumulation in the obstructed part of the lesion.A rigid guide wire was placed through the catheter to the lesion obstruction site, and the obstruction site and length were determined again.Endoscopic sems implantation: intravenous injection of midazolam, phloroglucinol and dezocine, observation of the guide wire placed in the stenotic site under dsa, and the smooth passage of the guide wire.In the stenotic part, a sems was introduced under direct vision.This complaint was opened to capture use of interventional stent placement (without endoscope) was off-label.As per ifu0052-11 that accompanies this device "introduce delivery system in short increments over wire guide, into accessory channel, until it is endoscopically visualised exciting the scope." no adverse effects noted in the literature paper as a result of the off label use.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) #k163468.Supplemental cancellation report is being submitted due to this complaint being cancelled.Additional clinical input received on 11-feb-2023 confirmed the use of interventional stent placement (without endoscope) was user error and not off-label use as per the initial assessment.As per ifu0052 that accompanies this device "introduce delivery system in short increments over wire guide, into accessory channel, until it is endoscopically visualised exciting the scope." complaint file is being cancelled as (b)(4)/mdr ref #3001845648-2023-00032 is already opened to capture user error noted in this literature paper.(b)(4)/mdr ref #3001845648-2023-00032 will be updated to include details of this complaint.

Event Description

Supplemental cancellation report is being submitted due to this complaint file being cancelled.Additional clinical input received on 11-feb-2023 confirmed the use of interventional stent placement (without endoscope) was user error and not off-label use as per the initial assessment.As per ifu0052 that accompanies this device "introduce delivery system in short increments over wire guide, into accessory channel, until it is endoscopically visualised exciting the scope." complaint file is being cancelled as (b)(4) /mdr ref #3001845648-2023-00032 is already opened to capture user error noted in this literature paper.(b)(4) /mdr ref #3001845648-2023-00032 will be updated to include details of this complaint.

• 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: 16182663
• MDR Text Key: 309323540
• Report Number: 3001845648-2023-00031
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 07/21/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 03/09/2023
• 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 Age: 56 YR
• Patient Sex: Male