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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/18/2023

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

Vanella et al 2023- eus-guided gastroenterostomy for management of malignant gastric outlet obstruction: a prospective cohort study with matched comparison with enteral stenting.A total of 104 patients were treated for mgoo during the study; 70 (58.6% male subjects; median age, 64 [interquartile range, 58-73] years; 75.7% pancreatic cancer, 60.0% metastatic cancer) underwent eus-ge via the wireless simplified technique.Technical success was 97.1% and clinical success was 97.1% after a median of 1.5 (interquartile range, 1-2) days.Adverse events occurred in 9 (12.9%) patients.Es cohorts were matched according to baseline frailty and oncologic.More aes was noted in the es group (25.0% vs 7.1%, p z.07), mostly related to interference of duodenal self-expandable metal stents with the papillary region or pre-existing biliary self-expandable metal stents.After a guidewire has been placed through the stenosis, contrast injection is used to depict the stenosis, sometimes with the help of a large-caliber (20 mm) fogarty balloon.An uncovered through-the-scope duodenal stent (evolution [cook medical, bloomington, ind, usa] or wallflex [boston scientific]) 22 mm in diameter and 6 to 12 cm in length is thereafter released across the stenosis under fluoroscopic guidance.(n 28).Event description: symptom recurrence/ occlusion/obstruction.Adverse events - mild ¿ moderate (1).Severe-fatal(6).N=1 patient had "repeat endoscopy for an adverse event, n=6 patient had "surgery for an adverse event.

Manufacturer Narrative

Pma/510(k) # k163468 device evaluation: the 7x evolution® duodenal controlled-release stent - uncovered devices of unknown rpn and lot numbers involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to the journal article ¿vanella 2023 - eus-guided gastroenterostomy for management of malignant gastric outlet obstruction: a prospective cohort study with matched comparison with enteral stenting¿ to capture ¿symptom recurrence (italy)¿.The following were also raised in response to this journal article: ¿ 414809 - vanella et al 2023- symptom recurrence (belgium) ¿ 414810 - vanella et al 2023- user error - chemotherapy post-stent placement (italy) ¿ 414811 - vanella et al 2023- user error - chemotherapy post-stent placement.(belgium) the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.An adverse event has been reported without a device problem.A device malfunction was not reported.Trending will monitor if any future investigation is required.Manufacturing records 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.Instructions for use and/label review: as per the ifu (ifu0053), stent occlusion is a known potential adverse event associated with gi endoscopy "those associated with gi endoscopy include, but are not limited to: airway obstruction, allergic reaction to contrast to medication, aspiration, biliary obstruction, cardiac arrhythmia or arrest, cholangitis, fever, hemorrhage, hypotension, infection, perforation, reflux, respiratory depression or arrest." ¿additional complications include, but are not limited to: allergic reaction to nickel, bowel impaction, death (other than due to normal disease progression.), erosion of the luminal mucosa, foreign body sensation, inadequate expansion, intestinal perforation, nausea/vomiting, pain/discomfort, pancreatitis, pressure necrosis, septicemia, stent misplacement and/or migration, stent occlusion, tumour ingrowth or overgrowth, ulcerations.¿ there is evidence to suggest that the customer did not follow the instructions for use.It should be noted that the instructions for use (ifu0053) states the following: ¿after stent placement, alternative methods of treatment such as chemotherapy and radiation should not be administered as this may increase the risk of stent migration due to tumour shrinkage, stent erosion and/or mucosal bleeding¿.According to the literature paper, 15 patients received chemotherapy post-stent placement.The chemotherapy was deemed un-related to the recurrence of the obstructive symptoms therefore sperate complaints were opened to capture the use-error (pr 414810 and pr 414811).Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to a procedural adverse event.As per the ifu, stent occlusion is a known procedural adverse event associated with gi endoscopy.As per medical advisor input, the stent occlusion could also have been caused by patient pre-existing conditions.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 07 used devices.Summary of investigation: according to the journal article, the patient did not experience any adverse effects due to this occurrence.The patient experienced a recurrence of symptoms as a result.As per definitions section of paper, "symptom recurrence was defined as recurrence of obstructive symptoms (gooss score 1) after former clinical success, regardless of whether it was caused by stent dysfunction or other reasons".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 14-mar-2024.

• 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: 18265802
• MDR Text Key: 329720022
• Report Number: 3001845648-2023-00886
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• 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: 03/14/2024

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male