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

Model Number G48028

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

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

Scope passed near to ca and they passed guide wire into lumen and checked with x ray, guide wire was well placed, after that they taken our stent into lumen over guide wire.After conforming all status they started deploying our stent.Stent was not opening for long time and its not coming out from delivery system.No additional details provided to date.

Manufacturer Narrative

Component code (annex g): g04122 ¿ stent.Device evaluation: the evo-25-30-8-c device of lot number c1617949 involved in this complaint was not returned for evaluation.With the information provided, a document based investigation was conducted.From the images provided it appears that the stent was partially deployed.Also it appears like there could be a bend/kink inside the flexor.As per additional information provided, "partially deployed stent removed from the patient." documents review including ifu review: prior to distribution all evo-25-30-8-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.A review of the manufacturing records for evo-25-30-8-c device of lot number c1617949 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1617949; upon review of complaints this failure mode has not occurred previously with this lot #c1617949.The instructions for use ifu0052-11 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is evidence to suggest that the customer did not follow the instructions for use.From additional information provided the product was not inspected for kinks or damage before use.A notification was sent to the product manager to consider retraining at the facility root cause review: a definitive root cause could not be determined from the limited available information.A possible root cause could be attributed to device handling.From additional information provided the product was not inspected for kinks or damage before use.It is possible that the introducer got damaged on handling/removal of the device from the packaging before use.Additionally it is also possible that during deployment tortuous patient anatomy path may have caused a build-up of pressure causing a bend/kink inside the flexor and subsequently led to stent deployment difficulties.As per additional information provided patient had cancer block in transfer colon.However, as the device was not returned for evaluation and due to limited information provided the cause of this complaint could not be conclusively determined.Summary: customer complaint is confirmed based on customer testimony.The patient outcome is unknown, as no information was provided.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• 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: 11009960
• MDR Text Key: 253086943
• Report Number: 3001845648-2020-00945
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)210529(10)C1617949
• 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
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2021
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1617949
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/17/2020
• Event Location: Hospital
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR