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

Model Number G48038

Device Problems Break (1069); Structural Problem (2506)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/14/2021

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

The inner catheter shows to be in the patient after 3 days after the stent was implanted.Stent placement required of two recaptures before the final stent placement (no problems); they pulled off the security wire guide (no problem).The stent was perfectly placed and it began to drain all debris, nevertheless they endoscopically saw something weird but couldn't be clearly seen, too much debris.Next monday they made an x-ray and they found what they supposedly saw.A section of the device did remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.A second colonoscopy to extract the piece of catheter broken and left inside the colon.Patient outcome: a section of the device did remain inside the patient¿s body.The patient did require any additional procedures due to this occurrence.A second colonoscopy to extract the piece of catheter broken and left inside the colon.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due an image review being received.Image review received 13-aug-21: "delivery system separation with retention of inner cannula fragment is confirmed".

Event Description

Final mdr being submitted due to completion of the investigation on 07-oct-21.

Manufacturer Narrative

Pma/510(k) #: k163468.Device evaluation: the evo-25-30-10-c device of lot number c1779448 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution 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 a review of the manufacturing records for evo-25-30-10-c of lot number c1779448 did not reveal any discrepancies that could have contributed to this complaint issue.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 c1779448.It should be noted that the instructions for use, ifu0052-11, states the following: ¿if an abnormality is detected that would prohibit proper working condition, do not use¿.There is not sufficient evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: 1.An abdominal x-ray reportedly performed three days post implantation is provided along with the complaint report.2.The complaint concerns a retained piece of the delivery system after deployment without fluoroscopy.3.The x-ray was likely taken in the standard ap projection.The shadow is absent and the stomach bubble present on the left.4.The inner cannular from the tip to past the yellow marker was inside the descending colon and the stent.5.The stent is slightly more distal in a long stenosis at descending and sigmoid colon junction.Impression: delivery system separation with retention of an inner cannula fragment is confirmed.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to torturous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the inner catheter break.Summary: complaint is confirmed as the failure was verified in the image.Delivery system separation with retention of an inner cannula fragment was confirmed in the imaging review.A second colonoscopy to extract the piece of catheter broken and left inside the colon was required 3 days after the initial stent was implanted.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.Note that this file is related to (b)(4) (emdr 3001845648-2021-00770) (user error: deployment without fluoroscopy).

• 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: 11997503
• MDR Text Key: 256182608
• Report Number: 3001845648-2021-00495
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)221120(10)C1779448
• 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: 10/07/2021

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: 11/20/2022
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1779448
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 05/18/2021; 05/18/2021
• Supplement Dates FDA Received: 09/09/2021; 11/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention