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

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

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

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 user error.It is stated in the ifu that chemotherapy should not be administered after stent placement.As per ifu0052-11 that accompanies this device "after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of migration due to tumor shrinkage, stent erosion and /or mucosal bleeding." no adverse effects noted in the literature paper as a result of the off label use.

Event Description

Supplemental follow-up report is being submitted due to the receipt of additional clinical input on 11-feb-2023 confirming the use of interventional stent placement (without endoscope) was user error and not off-label use as per the initial assessment.This complaint will capture this user error also and related complaint (b)(4) / mdr ref#(b)(4) (off-label use) will be cancelled.Updated description of event: 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 user error.It is stated in the ifu that chemotherapy should not be administered after stent placement.As per ifu0052-11 that accompanies this device "after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of migration due to tumor shrinkage, stent erosion and /or mucosal bleeding." additional clinical input received on 11-feb-2023 confirming the use of interventional stent placement (without endoscope) was user error and not off-label use as per the initial assessment.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." this complaint will also capture this user error.

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.Device evaluation: user/use related complaints is considered foreseen misuse.It is unknown how the device will perform outside of instructions for use and/or labelling requirements.The user has not complied with the requirements of the ifu and/label.Trending will monitor if any future investigation is required the device evaluation of evolution® colonic controlled-release stent - uncovered could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file was raised from literature ¿zhang et al 2022¿ to capture user error for chemotherapy that was administered post stent placement and the stents were placed without an endoscope.Manufacturing records: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Instructions for use and/label : the instructions for use, ifu0052 which accompanies this device, instructs the user that ¿¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumour shrinkage, sent erosion, and/or mucosal bleeding.¿¿ and ¿¿ stent should be placed endoscopically with fluoroscopic monitoring.¿¿ there evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause was established.The user has not complied with the requirements of the ifu/label.The instructions for use, ifu0052 which accompanies this device, instructs the user that ¿¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumour shrinkage, sent erosion, and/or mucosal bleeding.¿¿ and ¿¿ stent should be placed endoscopically with fluoroscopic monitoring.¿¿ it is known from the available information that chemotherapy was administered post stent placement and the stents were placed without an endoscope.Corrective action: complaints of this nature will continue to be monitored for potential emerging trends.Confirmation of complaint : complaint is confirmed based on customer and/or rep testimony.Summary of investigation: according to the literature chemotherapy was administered post stent placement and interventional stent placement(without an endoscope) was used.Confirmed quantity of 95 device, confirmed used.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude a definitive root cause was established.The user has not complied with the requirements of the ifu/label.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 29-nov-2023.

• 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: 16182688
• MDR Text Key: 308627179
• Report Number: 3001845648-2023-00032
• 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,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• 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
• Date Manufacturer Received: 12/19/2022
• 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