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

Catalog Number EVO-22-27-6-D

Device Problem Off-Label Use (1494)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Sandhu et al - uncovered duodenal stent removal: should it be attempted? due to poor surgical candidacy, patient opted for palliative duodenal stent insertion.A repeat esophagogastroduodenoscopy (egd) showed friable, malignant appearing severe narrowing at the d1/d2 segment of duodenum.Multiple biopsies were taken and a cook evolution uncovered duodenal stent 6 cm x 22 mm was placed across the stricture.Biopsies showed necro inflammatory tissue.Due to high concern for malignancy, a repeat egd with multiple additional biopsies were done, however the pathology remained non-diagnostic for malignancy.About 10 weeks post stent insertion, patient regained her baseline weight and desired removal of stent.Surgical option was given to the patient but she opted for endoscopic attempt at removal of stent.Egd performed under general anaesthesia/ intubation and using carbon dioxide (co2) for insufflation showed duodenal mucosa embedding into the stent.Stent was dislodged by gentle manipulation with the scope tip and a rat-tooth forceps and then successfully pulled out by inversion and traction.A re-look endoscopy did not reveal evidence of perforation.Patient was admitted overnight.A computed tomography abdomen done showed no evidence of perforation.Subsequent to this, she underwent dilation of the stricture and is doing well 3 months later.This file will capture the off-label usage of the evolution duodenal stent used on a patient without malignancy.

Manufacturer Narrative

Device evaluation the 1x evo-22-27-6-d device of unknown lot number involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.The following files were also raised from this journal article: ¿ (b)(4): sandhu et al - user error lab evaluation the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document review prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data review historical data was not reviewed as the lot number is unknown.Ifu & label review it was noted in the journal article that the evo-22-27-6-d device was used to treat non-malignant conditions.As per the journal article ¿due to high concern for malignancy, a repeat egd with multiple additional biopsies were done, however the pathology remained non-diagnostic for malignancy.¿ as per the ifu0053-10, the intended use for a evolution duodenal stent system ¿ uncovered is as follows; ¿this device is used for palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms.¿ as the device was used in contradiction to the intended use outlined in the ifu, there is evidence to suggest that the used did not follow the instruction for use.Image review an image was not returned for evaluation.Root cause review a definitive root cause of off-label use was identified from the available information.The evolution uncovered duodenal stent system is not intended to be used in non-malignant conditions however the stent was placed in a patient who was confirmed to have tested negative for malignancy.Summary the complaint is confirmed based on customer testimony.According to the journal article, there was no patient outcome or adverse events reported.The medical advisor also confirmed there were no complications.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 on 09mar2023.

• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 16379265
• MDR Text Key: 309583587
• Report Number: 3001845648-2023-00107
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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 Catalogue Number: EVO-22-27-6-D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 73 YR
• Patient Sex: Female