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

Model Number G48026

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

The 510 (k) number: k163468.(b)(4).Device evaluation: the evo-22-27-9-d device of lot number c1385740 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.Patient pre-existing conditions: pancreas cancer.Additional information received: was resistance encountered when advancing the wire guide through the stricture? - no.Was resistance encountered when advancing the introducer and stent into position? - no.Was dilation of the stricture completed prior to stent placement? - no.What was the diameter of the stricture? (mm) - unknown.What was the length of the stricture? (cm) - 4cm.(esophageal only) was the stent placed at the gastroesophageal junction? - n/a.Was the endoscope advanced into the stent after placement? - no.Did the patient undergo chemotherapy or radiation treatments after stent placement? - unknown.Images were not provided to support the complaint investigation.Therefore they could not be reviewed through cook research inc.(cri) root cause: a definitive root cause for the customer complaint could not be determined due to the limited information available and no images available for review.However, a possible root cause could be attributed to, as stated in the description of event ¿it was confirmed that the patient had been undergoing chemotherapy after stent placement¿.As per ¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumor shrinkage, stent erosion, and/or mucosal bleeding¿.Document 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 (b)(4).A review of the qc records for lot number c1385740 did not reveal any issues which could have contributed to this complaint issue.Manufacturing wok instructions include the following inspections; ¿inspect for visual defects; i.E.Loose or embedded foreign materials, rough or sharp edges, kinks.¿ ¿ensure that there are no sharp edges or damage to the sheath tip area." ¿deploy the stent approximately 50%.¿ upon review of complaints, this failure mode has not occurred previously with the lot number c1385740.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1385740.Ifu review: as per ifu, ¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase risk of stent migration due to tumor shrinkage, stent erosion, and/or mucosal bleeding¿.As stated in the description of event ¿it was confirmed that the patient had been undergoing chemotherapy after stent placement¿.This therefore may have led to the stent becoming fractured.On review of the information provided, there is evidence to suggest that the user did not follow the instructions for use.Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.From the information provided, there have been no adverse effects to the patient as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Around (b)(6) 2018: the stent was placed in the curved site of the duodenum.On (b)(6) 2018: when olympus's jf-260v endoscope was inserted into the patient to treat cholangitis, the physician found that the stent wires forming "crowns" or near the "crown" at the stomach side was appeared to be broken and the stent edge was deformed.Since the endoscope could not be advanced through the stent due to the deformation of the stent edge, the physician had to leave the cholangitis untreated.The damaged stent remained inside the patient with no additional treatment as well.There have been no adverse effects to the patient reported.Updated with additional information (29/aug/2018, (b)(4)): it was confirmed that the patient had been undergoing chemotherapy after stent placement.

Manufacturer Narrative

510 (k) number: k163468.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.This follow up report is being submitted to amend the root cause documented in the previous report.Root cause: a definitive root cause for the customer complaint could not be determined due to the limited information available and no images available for review.However, a possible root cause could be attributed to patient anatomy.

Event Description

This follow up is being sent as a correction report around (b)(6) 2018: the stent was placed in the curved site of the duodenum.(b)(6) 2018: when olympus's jf-260v endoscope was inserted into the patient to treat cholangitis, the physician found that the stent wires forming "crowns" or near the "crown" at the stomach side was appeared to be broken and the stent edge was deformed.Since the endoscope could not be advanced through the stent due to the deformation of the stent edge, the physician had to leave the cholangitis untreated.The damaged stent remained inside the patient with no additional treatment as well.There have been no adverse effects to the patient reported.Updated with additional information (29/aug/2018, (b)(6)).It was confirmed that the patient had been undergoing chemotherapy after stent placement.

• 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: 7906175
• MDR Text Key: 122166939
• Report Number: 3001845648-2018-00444
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 10827002480268
• UDI-Public: (01)10827002480268(17)190803(10)C1385740
• 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: 04/18/2019

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: 08/03/2019
• Device Model Number: G48026
• Device Catalogue Number: EVO-22-27-9-D
• Device Lot Number: C1385740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 08/28/2018
• Supplement Dates FDA Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1