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

Catalog Number UNKNOWN

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Feng et al 2020 ¿ endoscopic self-expandable metallic stent insertion without fluoroscopic guidance is feasible and safe for acute colonic obstruction caused by colorectal cancer.Rpn used: exact rpn unknown, 3 possible rpns: evo-25-30-6-c, evo-25-30-8-c, evo-25-30-10-c.It cannot be confirmed of the overall 36 stents placed, which were cook stents, this file is created to capture the potential that it could have been a cook evolution stent.The objective of this study was to evaluate the efficacy and feasibility of this technique using sems insertion.From january 2016 to december 2018, 36 patients with crc obstruction underwent endoscopic sems insertion in our center.The whole stenting procedure was monitored under endoscopic guidance only.A through-the-scope technique was used for all stent insertions.A niti-s uncovered colorectal stent with a diameter of 22¿25mm and a length of 100mm from microtech ((b)(6)) or cook medical evolution ((b)(6) usa) was used according to the endoscopist¿s preference.Briefly, when the colonoscope reached the obstruction, a sphincterotome (microtech, (b)(6)) for endoscopic retrograde cholangiopancreatography (ercp) with a 0.035-inch guidewire (micro-tech, (b)(6)) or jagwire (boston scientific, (b)(6), usa) was introduced.The guidewire was inserted to traverse the stricture.The guidewire was inserted for approximately 40 cm, then pulled backward at approximately 10 cm, followed by an additional insertion for approximately 20 cm.Successful guidewire insertion was judged by a smooth passage of the guidewire without any resistance.The sphincterotome was then inserted along the guidewire to confirm the passage of the obstruction.The delivery system was advanced over the guidewire and was guided into the site of obstruction until the distal end of the stent was approximately 2cm at the edge of the tumor.In the stent deployment procedure, the distal end of the stent was kept 2cm beyond the distal edge of the lesion, while the outer sheath was retracted.The whole procedure was monitored by the colonoscopic guidance only.This file was created to capture the off label use as no fluoroscopic monitoring was used.

Event Description

Supplemental report being submitted as the device code was updated following input from product mgt.On (b)(6) 2020.Feng et al 2020 : endoscopic self-expandable metallic stent insertion without fluoroscopic guidance is feasible and safe for acute colonic obstruction caused by colorectal cancer.Rpn used: exact rpn unknown, 3 possible rpns: evo-25-30-6-c, evo-25-30-8-c, evo-25-30-10-c.It cannot be confirmed of the overall 36 stents placed, which were cook stents, this file is created to capture the potential that it could have been a cook evolution stent.The objective of this study was to evaluate the efficacy and feasibility of this technique using sems insertion.From (b)(6) of 2016, to (b)(6) of 2018, 36 patients with crc obstruction underwent endoscopic sems insertion in our center.The whole stenting procedure was monitored under endoscopic guidance only.A through-the-scope technique was used for all stent insertions.A niti-s uncovered colorectal stent with a diameter of 22¿25mm and a length of 100mm from microtech (nanjing, china) or cook medical evolution (bloomington,in,usa) was used according to the endoscopist¿s preference.Briefly, when the colonoscope reached the obstruction, a sphincterotome (microtech, nanjing, china) for endoscopic retrograde cholangiopancreatography (ercp) with a 0.035-inch guidewire (micro-tech, (b)(6)) or jagwire (boston scientific, (b)(6)) was introduced.The guidewire was inserted to traverse the stricture.The guidewire was inserted for approximately 40 cm, then pulled backward at approximately 10 cm, followed by an additional insertion for approximately 20 cm.Successful guidewire insertion was judged by a smooth passage of the guidewire without any resistance.The sphincterotome was then inserted along the guidewire to confirm the passage of the obstruction.The delivery system was advanced over the guidewire and was guided into the site of obstruction until the distal end of the stent was approximately 2cm at the edge of the tumor.In the stent deployment procedure, the distal end of the stent was kept 2cm beyond the distal edge of the lesion, while the outer sheath was retracted.The whole procedure was monitored by the colonoscopic guidance only.This file was created to capture the off label use as no fluoroscopic monitoring was used.As per fda guidance: average patient age and weight, as well as the gender of the majority of patients involved/individual patient info if available 36 patients with crc obstruction underwent endoscopic sems insertion in our center.23 males (63.9%) and 13 females (36.1%) with an average age of 72 years.

Manufacturer Narrative

Supplemental report being submitted as the device code was updated following input from product mgt.On 09-sep-2020.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Feng et al 2020 ¿ endoscopic self-expandable metallic stent insertion without fluoroscopic guidance is feasible and safe for acute colonic obstruction caused by colorectal cancer.Rpn used: exact rpn unknown, 3 possible rpns: evo-25-30-6-c, evo-25-30-8-c, evo-25-30-10-c.It cannot be confirmed of the overall 36 stents placed, which were cook stents, this file is created to capture the potential that it could have been a cook evolution stent.The objective of this study was to evaluate the efficacy and feasibility of this technique using sems insertion.From (b)(6) 2016 to (b)(6) 2018, 36 patients with crc obstruction underwent endoscopic sems insertion in our center.The whole stenting procedure was monitored under endoscopic guidance only.A through-the-scope technique was used for all stent insertions.A niti-s uncovered colorectal stent with a diameter of 22¿25mm and a length of 100mm from microtech (nanjing, china) or cook medical evolution(bloomington,in,usa) was used according to the endoscopist¿s preference.Briefly, when the colonoscope reached the obstruction, a sphincterotome (microtech, nanjing, china) for endoscopic retrograde cholangiopancreatography (ercp) with a 0.035-inch guidewire (micro-tech, nanjing, china) or jagwire (boston scientific, natick, ma, usa) was introduced.The guidewire was inserted to traverse the stricture.The guidewire was inserted for approximately 40 cm, then pulled backward at approximately 10 cm, followed by an additional insertion for approximately 20 cm.Successful guidewire insertion was judged by a smooth passage of the guidewire without any resistance.The sphincterotome was then inserted along the guidewire to confirm the passage of the obstruction.The delivery system was advanced over the guidewire and was guided into the site of obstruction until the distal end of the stent was approximately 2cm at the edge of the tumor.In the stent deployment procedure, the distal end of the stent was kept 2cm beyond the distal edge of the lesion, while the outer sheath was retracted.The whole procedure was monitored by the colonoscopic guidance only.This file was created to capture the off label use as no fluoroscopic monitoring was used.

Manufacturer Narrative

510(k) number: k163468.Device evaluation: the evolution® colonic controlled-release stent - uncovered devices of unknown lot numbers involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the attached journal article.This file pr 306264 was opened to investigate no fluoroscopic monitoring.Documents review including ifu review: prior to distribution all evolution® colonic controlled-release stent - uncovered devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The instructions for use ifu0052-11 which accompanies this device instructs the user to "to ensure that the stent will bridge stricture after deployment, fluoroscopically position radiopaque markers on inner catheter beyond extremities of strictures to be crossed.Confirm desired stent position fluoroscopically ad deploy stent by removing red safety guard from the handle.Also as per instructions for use ifu0052-11 which accompanies precautions: "stent should be placed endoscopically with fluoroscopic monitoring" there is evidence to suggest that the customer did not follow the instructions for use, the stent was deployed and no fluoroscopy was used.Root cause review: a definitive root cause could be attributed to user error, from the additional information provided the stent was deployed and no fluoroscopy was used.Summary: complaint is confirmed based on customers testimony.Patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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
• MDR Report Key: 10433151
• MDR Text Key: 242646178
• Report Number: 3001845648-2020-00513
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/10/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR