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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abdominal Distention (2601)

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

510 k # k163468 investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Haiyang lai, 2022 ¿ efficacy and safety of self-expandable metal stent placement for treatment of primary and metastatic gastric outlet obstruction.The data of 42 patients with goo who received sems from november 2016 to april 2022 were reviewed retrospectively.Patients were divided into primary group (n = 25) and metastatic group (n = 17) according to the cause of goo.The rates of technical and clinical success, stent patency, and complications were compared between the two groups.The body diameter and flare of cook evolution duodenal stent (cook medical, limerick, ireland) was 22 mm and 27 mm, and length varied from 6, 9, to 12 cm.A 0.90-mm-wide, 150-cmlong terumo guide wire (terumo corporation, tokyo, japan); a 5-french dav catheter (cook medical, bloomington, in, usa); an 8-french guiding catheter (boston scientific, marlborough, ma, usa); a 0.035-in-wide, 450-cm-long zebra guidewire (boston scientific, natick, ma, usa); a 10-french, 240-cm long nasojejunal tube (wilson-cook medical, usa); liquid paraffin oil; and ge flat-panel digital subtraction angiography system (innova3100) were used.Abdominal pain: six patients in the primary group had abdominal pain and distension within 3 days after stent implantation and recovered within 1 week.In the metastatic group, three patients had abdominal pain and distension within 3 days after stent implantation, and the symptoms were relieved within 1 week.Please note as per clinical input - placement of evo-duodenal stent without endoscopic procedure is off-label use.The stent placement procedure was off-label.E.Pain/discomfort s=2.A total of 42 patients were included in this study.The patients comprised 28 (66.7%) males and 14 (33.3%) females, with a mean age of 57.1 ± 12.7 (29.0¿82.0) years.

Manufacturer Narrative

Pma/510(k) #k163468 device evaluation: the 09x evolution® duodenal controlled-release stent - uncovered devices of unknown rpn and lot number involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to the journal article ¿efficacy and safety of self-expandable metal stent placement for treatment of primary and metastatic gastric outlet obstruction¿ to capture 09 cases of abdominal pain.The following files were also opened from this journal article: - pr 396414 user error: placement of devices without endoscopic procedure - pr 385309 patients received chemotherapy after sems placement - pr 385310 fever and infection - pr 385312 stent malfunction 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.Instructions for use and/label review: as per the ifu (ifu0053), pain is a known potential adverse event associated with gi endoscopy ¿additional complications include, but are not limited to: pancreatitis, intestinal perforation, pain, inadequate expansion, stent misplacement and/or migration, tumour ingrowth or overgrowth, stent occlusion, ulcerations, pressure necrosis, erosion of the luminal mucosa, septicaemia, foreign body sensation, bowel impaction, death (other than due to normal disease progression).¿ there is no evidence to suggest that the customer did not follow the instructions for use or product label.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 (ifu0053), pain is a known potential adverse event associated with gi endoscopy.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: as per the journal article, six patients in the primary group and three patients in the metastatic group had abdominal pain and distention after stent implantation.Confirmed quantity of 09 used devices.The investigation findings concluded a possible root cause of procedural adverse events.As per the ifu (ifu0053), pain is a known potential adverse event associated with gi endoscopy.Complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient experienced an adverse effect due to this occurrence.09 patients suffered abdominal pain with all patients¿ symptoms relieving successfully within 1 week.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 (b)(6) 2023.

• 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: 16156579
• MDR Text Key: 309299143
• Report Number: 3001845648-2023-00017
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/04/2023

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/28/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 08/02/2023
• 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