MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED; MUM STENT, METALIC EXPANDABLE, DUODENAL

Model Number G48026

Device Problems Activation, Positioning or Separation Problem (2906); Insufficient Information (3190)

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

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4) us clearance number.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Stent set up on a guide wire of 0.025 inch.During deployment, the team hears a snap, and there is no resistance felt.An x-ray is made but the deployment of the stent is not visible, the team tried to retrieve the stent but without success.It has been removed from the endoscope.The team used an other device to end up the procedure.

Event Description

Stent set up on a guide wire of 0.025inch.During deployment, the team hears a snap, and there is no resistance felt.An x-ray is made but the deployment of the stent is not visible, the team tried to retrieve the stent but without success.It has been removed from the endoscope.The team used an other device to end up the procedure.

Manufacturer Narrative

(b)(4)- us clearance number.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

This is a cancellation report.Based on the investigation the physician/assistant fails to select appropriate wire guide.Overall risk category assigned iii (low risk)., the event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016).No malfunction precedence exists also.510k # k163468 device evaluation: the evo-22-27-9-d device of lot number c1544017 involved in this complaint device was not returned for evaluation.With the information provided document based investigation was conducted.Documents review including ifu review: prior to distribution all evo-22-27-9-d 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-22-27-9-d device of lot number 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 #c1544017; upon review of complaints this failure mode has not occurred previously with this lot #c1544017.An nc code (gen-001bent/kinked/dent) was noted on the work order, however this was subsequently reworked and would not have attributed to this complaint issue.An nc code (pac-010 product damage) was noted on the work order, however this was subsequently scrapped and would not have attributed to this complaint issue.The instructions for use ifu0053-9 which accompanies delivery system description and instructs the user to "the stent is mounted on an inner catheter, which accepts a.035 inch wire guide, and is constrained by an outer catheter." there is evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause of failure could be attributed to user error, the investigation has determined that here is evidence to suggest that the customer did not follow the instructions for use ifu0053-9 "the stent is mounted on an inner catheter, which accepts a.035 inch wire guide, and is constrained by an outer catheter." however as per complaint description information received 0.025 inch wire guide was used, this may have been a possible contributing factor to the flexor damage as it may not have provided sufficient support and testing has not been carried out with this size wireguide to understand the interaction with it.However, as the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary: patient outcome is unknown, from complaint description "the team used another device to end up the procedure." customer complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This is a cancellation report.Based on the investigation the physician/assistant fails to select appropriate wire guide.Overall risk category assigned iii (low risk).The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016).No malfunction precedence exists also.

• Brand Name: EVOLUTION DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9395357
• MDR Text Key: 168643252
• Report Number: 3001845648-2019-00656
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)200927(10)C1544017
• 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: 02/10/2020

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: 09/27/2020
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1544017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 11/05/2019; 11/05/2019
• Supplement Dates FDA Received: 12/24/2019; 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention