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

Catalog Number EVO-22-27-9-D

Device Problems Premature Activation (1484); Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Event Description

When the stent was taken out of the package the soul of the stent was already revealed at the distal end.(this complaint) it was also not possible to insert a wire.(another complaint has been created to capture this) "as per cc form": when the stent was removed from its packaging, the core of the stent was already visible at the distal end.No wire could be inserted either.After several attempts, we had to take a new cook stent, which could be placed without any problems.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence "as with any stent, we assume it is functional and do not subject it to any special visual inspection - especially since the examination room is darkened at the time of the intervention anyway.The last outer packaging of the stent was removed and the defect was immediately noticed.We still tried to insert the wire already placed in the patient into the tip of the stent - without success.The stent was found by us as we sent it back to you now.The guidewire used was the jagwire straight tip, 0.035in x 450cm, from boston.We first tried to carefully push the protruding tip back into the catheter so that we could still use the stent if possible.Then we tried to thread the stent onto the lying wire despite the protruding tip - neither was possible.".

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental follow up report is being due to receipt and evaluation of the complaint device.Lab evaluation complete (b)(6) 2021: polyimide kinked/damaged.'.

Manufacturer Narrative

Device evaluation: 1 unit of device evo-22-27-9-d and lot# c1835797 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.  following the initial review of the complaint information additional information was requested and provided to aid this investigation : was the device visually inspected prior to removal from the packaging? - as with any stent, we assume it is functional and do not subject it to any special visual inspection - especially since the examination room is darkened at the time of the intervention anyway.At what stage was the white tip and core observed? - the last outer packaging of the stent was removed and the defect was immediately noticed.Was the wire guide inserted into the catheter? we still tried to insert the wire already placed in the patient into the tip of the stent - without success.What was the intent of inserting the wire guide? to continue the procedure? - we first tried to carefully push the protruding tip back into the catheter so that we could still use the stent if possible.Then we tried to thread the stent onto the lying wire despite the protruding tip - neither was possible." it was agreed with engineering that an additional file (pr342403) be opened to capture user error pushing the exposed section back into the outer sheath in an attempt to proceed with the procedure.  lab evaluation: on evaluation of the device it was observed that the polyimide was kinked/damaged.Safety wire in place on return of the device.Red marker on top of the handle at 7mm dimpling on return of the device.Polyimide exposed approximately 2cm from the device on return.Actuation of handle was possible, stent deployed without any issues.Lock wire removed without issues.Stent intact.Document review: prior to distribution 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 of lot number c1835797 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 c1835797.It should be noted that the instructions for use (ifu0053-10) states the following: ¿if the package is opened or damaged when received, do not use.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 sufficient evidence to suggest the user did not follow the ifu.  root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to transportation or storage facilities.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The observation was made prior to patient contact.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® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 12588752
• MDR Text Key: 283956999
• Report Number: 3001845648-2021-00715
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1835797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 09/10/2021; 09/10/2021
• Supplement Dates FDA Received: 11/04/2021; 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1