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 Hemorrhage/Bleeding (1888)

Event Date 05/26/2022

Event Type  Injury  

Event Description

Harima et al 2022 - comparison of duodenal stenting and gastrojejunostomy for duodenal obstruction with biliary obstruction this complaint was opened to capture bleeding the present study aimed to compare clinical outcomes between dus and gj in patients with double obstruction who underwent biliary stenting.The present study further aimed to analyze the risk factors associated with survival time and time to recurrent biliary obstruction (trbo) dus was performed using evolution duodenal stent; 22-mm diameter,was performed either with an open or laparoscopic approach based on the description of performing surgeons.Biliary stenting was performed with the ptbd approach, ercp approach or eus-bd approach based on the description of the performing physicians.For the ptbd approach, an uncovered 10-mm-diameter sems (epic biliary stent; boston scientific) was placed after temporary external drainage.For the ercp approach, a covered or an uncovered 10-mm-diameter sems was placed, and when eus-guided hepaticogastrostomy combined with antegrade stenting (eus-hgas) was performed, an uncovered 10-mm-diameter sems (zilver stent; cook medical or niti- s large cell sr slim delivery; taewoong medical) and a dedicated 8-fr plastic stent were placed.This complaint was opened to capture bleeding after placement of evo-22-**-d stent.As per clinical input 'require intervention/additional procedures.' 84 underwent dus.Age 72.Male, n 39(46.4%).

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: the device evaluation for evolution® duodenal device of unknown lot could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: 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.Review historical data: historical data was not reviewed as the lot number is unknown.Instructions for use and/label as per the instructions for use, ifu0053, which accompanies this device it informs the user about the potential complications ¿those associated with gi endoscopy include but are not limited to: perforation, haemorrhage, aspiration, reflux, fever, infection, allergic reaction to medication, hypotension , respiratory depression or arrest, cardiac arrythmia or arrest.¿.There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a.Root cause analysis a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, haemorrhage is listed as a potential complication following the placement of this device.Summary of investigation: according to the literature 3 cases of bleeding occurred.Confirmed quantity of 3 device, confirmed used.The patient¿s outcome is unknown.Investigation findings conclude a definitive root cause was not established.A possible root cause could be attributed to the instructions for use, (ifu0053), haemorrhage is listed as a complication following the placement of this device.Complaint is confirmed based on customer and/or rep testimony.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 04-mar-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): WILLIAM COOK EUROPE; sandet 6; national technology park; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: lissi walmann ; sandet 6; national technology park; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 16205808
• MDR Text Key: 307701596
• Report Number: 3001845648-2023-00035
• 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: 03/04/2023

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?: No
• 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: 05/26/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 03/30/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female