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

Model Number G48038

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

K163468 - us clearance number.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Complaint called in by dm on 15nov2019--did 15nov2019.As reported to customer relations: "stent would not deploy off the catheter.Unknown what the problem, dm and customer tried all troubleshooting they could think of and were not successful.(dm was not present, troubleshooting took place over the phone).Pulled it out and aborted.Will be reattempting today with the dm present." a competitive device was utilized the next day with x-ray and representative (myself and competitor) there to support the staff and physician.Additional information received 10-dec-2019: the patient received a cat scan that evening (of the initial surgery) that showed that the stent was actually misdeployed proximal to the stricture.The stent was actually left in the patient and the physician did not use fluoroscopy during initial stent placement.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.Due to requirement ct scan and requirement for additional procedure next day to place competitor stent.

Manufacturer Narrative

K163468: us clearance number.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Complaint called in by (b)(6) on (b)(6) 2019; (b)(6) on (b)(6) 2019.As reported to customer relations: "stent would not deploy off the catheter.Unknown what the problem, (b)(6) and customer tried all troubleshooting they could think of and were not successful.( (b)(6) was not present, troubleshooting took place over the phone).Pulled it out and aborted.Will be reattempting today with the (b)(6) present." a competitive device was utilized the next day with x-ray and representative (myself and competitor) there to support the staff and physician.Additional information received 10-dec-2019: the patient received a cat scan that evening (of the initial surgery) that showed that the stent was actually misdeployed proximal to the stricture.The stent was actually left in the patient and the physician did not use fluoroscopy during initial stent placement.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.Due to requirement ct scan and requirement for additional procedure next day to place competitor stent.

Manufacturer Narrative

K163468: us clearance number.Device evaluation: the evo-25-30-10-c device of lot number: c1607646 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 09th january 2020.Device was returned disassembled and no stent returned.All cogs intact, manual deployment of introducer completed without issues.Following the lab evaluation, additional information was requested to aid the investigation.From the information provided: "the item is the correct item.The staff took it apart because they thought the internal mechanisms broke and were going to manually deploy the stent.The device was disassembled during the case.The physician asked for the stent and the tech opened the appropriate size as well as checked and flushed it as trained.Once the device was down the scope the physician asked the tech to deploy and the tech deployed the stent rapidly.This made the physician miss the ¿yellow¿ transition point and misdeploy the stent.No flouroscopy was used for this case.During this the physician and tech disassembled the handle to check if the stent was still on the catheter as they assumed it was.The catheter was removed and placed aside and left for me to pick up.I went in the following day and spoke to staff finding out that x-ray confirmed stent misdeployment after the case.I returned and rein serviced staff and they have had no issues after." from additional information provided "one device was used and misdeployed.Patient came back for a second procedure on the second day and a competitive stent was deployed correctly during the second visit." documents review including ifu review: prior to distribution all evo-25-30-10-c 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 review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number: c1607646.The instructions for use ifu0052-10 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 ifu0052-10 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 miss deployed as no fluoroscopy was use used.Image review: n/a.Root cause review: a definitive root cause could be attributed to user error, from the additional information provided the stent was miss deployed as no fluoroscopy was use used.Summary: according to the initial reporter, the patient required subsequent attempt to place stent, following day.Complaint is confirmed based on customers testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Complaint called in by (b)(6) on (b)(6) 2019.As reported to customer relations: "stent would not deploy off the catheter.Unknown what the problem, dm and customer tried all troubleshooting they could think of and were not successful.(dm was not present, troubleshooting took place over the phone).Pulled it out and aborted.Will be reattempting today with the dm present." a competitive device was utilized the next day with x-ray and representative (myself and competitor) there to support the staff and physician.Additional information received 10-dec-2019: the patient received a cat scan that evening (of the initial surgery) that showed that the stent was actually misdeployed proximal to the stricture.The stent was actually left in the patient and the physician did not use fluoroscopy during initial stent placement.

Event Description

Complaint called in by dm on (b)(6) 2019--did (b)(6) 2019.As reported to customer relations: "stent would not deploy off the catheter.Unknown what the problem, dm and customer tried all troubleshooting they could think of and were not successful.(dm was not present, troubleshooting took place over the phone).Pulled it out and aborted.Will be reattempting today with the dm present." additional information provided by dm on (b)(6) 2020: "the item is the correct item.The staff took it apart because they thought the internal mechanisms broke and were going to manually deploy the stent.The device was disassembled during the case.The physician asked for the stent and the tech opened the appropriate size as well as checked and flushed it as trained.Once the device was down the scope the physician asked the tech to deploy and the tech deployed the stent rapidly.This made the physician miss the ¿yellow¿ transition point and misdeploy the stent.No flouroscopy was used for this case.During this the physician and tech disassembled the handle to check if the stent was still on the catheter as they assumed it was.The catheter was removed and placed aside and left for me to pick up.I went in the following day and spoke to staff finding out that x-ray confirmed stent miss-deployment after the case.I returned and reinserviced staff and they have had no issues after.".

Manufacturer Narrative

K163468 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
• MDR Report Key: 9456796
• MDR Text Key: 186814932
• Report Number: 3001845648-2019-00712
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)210425(10)C1607646
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2021
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1607646
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/07/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 11/15/2019; 11/15/2019; 11/15/2019
• Supplement Dates FDA Received: 01/09/2020; 02/05/2020; 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention