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

Catalog Number UNKNOWN

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2020

Event Type  Injury  

Event Description

Patita et al, 2020 ¿ covered metal stent after dysfunction of uncovered stents for palliation of gastrointestinal malignant obstruction.All stents were deployed under endoscopic and fluoroscopic guidance in patients sedated with propofol.The stenting procedure was always performed with a forward viewing therapeutic endoscope (gif 2th 180; olympus medical systems, tokyo, japan) or colonoscope (cf-h180 or cf-hq190; olympus medical systems) with a 3.7-mm working channel the endoscope progressed to the stenosis site, and subsequently a guidewire was passed through it.A catheter was then placed through the stenosis, and a contrast medium was injected to estimate the stenosis length.A suitable stent length was chosen, considering the shortening of the stent after the extension.Finally, the stent was placed under endoscopic and fluoroscopic guidance.This file covers 2 cases of early stent dysfunction and 5 cases of late stent dysfunction patient outcome: require intervention/additional procedures s=4.Patient/event info - notes: patient info:12 patients; the patients included were mostly males (n = 8, 66.7%), (33.3% female) and their mean age was 60 ± 9 years (range 39¿75).

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # k163468 device evaluation: the 08 x evolution duodenal stents of unknown rpn and lot number involved in this complaint 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 ¿covered metal stent after dysfunction of uncovered stents for palliation of gastrointestinal malignant obstruction¿ to capture 02x cases of early stent dysfunction and 06 x cases of late stent dysfunction.All 08 cases of stent dysfunction were deemed attributed to tumour ingrowth as per clinical input.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.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.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), ¿tumour ingrowth¿ 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 known procedural adverse event.As per the ifu (ifu0053), ¿tumour ingrowth or overgrowth¿ is a known potential adverse event associated with the gi endoscopy.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Summary of investigation: as per the journal article, 07 patients (08 devices) experienced stent dysfunction (02 early cases, 06 late cases).As per medical advisor¿s clinical input, all stent dysfunction cases were attributed to tumour ingrowth of the stent and all cases would require intervention/prolonged procedures.Confirmed quantity of 08 used devices.The investigation findings and root cause concluded that the 8 cases of stent ingrowth were possibly attributed to the gi endoscopy procedure performed, as per the ifu, tumour ingrowth is a known potential adverse event associated with the procedure.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 12-jul-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: 16350106
• MDR Text Key: 309266365
• Report Number: 3001845648-2023-00089
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 07/12/2023

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: 05/13/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 08/10/2023
• 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: 60 YR
• Patient Sex: Male