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

Catalog Number UNKNOWN

Device Problems Complete Blockage (1094); Collapse (1099); Activation Failure (3270)

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

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 5 cases of absence of early clinical success, likely attributed to inadequate stent expansion to solve the obstruction.Require intervention/additional procedures s=4.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).

Event Description

Supplemental report is being submitted due to updated a code.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation: the 04x evolution® duodenal controlled-release stent - uncovered devices of unknown lot numbers 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 ¿patita 2020 - covered metal stent after dysfunction of uncovered stents for palliation of gastrointestinal malignant obstruction¿ to capture ¿04x cases of absence of early clinical success¿.The following was also raised in response to this journal article: (b)(4) - patita 2020 stent dysfunction 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.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), inadequate expansion and stent occlusion are a known potential adverse events 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 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 the patients pre-existing conditions and/or patient anatomy, or the study procedure.As per both the journal article and medical advisors¿ input, the absence of early clinical success can be possibly attributed to insufficient/inadequate usems expansion.As per the ifu, inadequate expansion is a known potential complication.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 04x used devices.Summary of investigation: according to the initial reporter, the patient did experience an adverse effect due to this occurrence.Patients 2, 4, 8, and 9 all had no clinical success due to occlusive symptoms remaining 24hrs post-placement.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 16-apr-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: 17324554
• MDR Text Key: 319299444
• Report Number: 3001845648-2023-00553
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K121430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 06/27/2023; 06/27/2023
• Supplement Dates FDA Received: 08/04/2023; 05/09/2024
• 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