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 Fever (1858); Unspecified Infection (1930)

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

Pma/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.Fever and infection: primary group five patients had fever and infection within 1 week after stent implantation; the patients recovered well without other discomfort under anti-infection measures.Metastatic group six patients had fever and infection within 1 week after stent implantation; more than half of the patients recovered well under anti-infection measures.Note: placement of evo-duodenal stent without endoscopic procedure is off-label use.Required antibiotics treatment 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.

Event Description

Supplemental report is being submitted as a cancellation report following the completion of the investigation as the complaint no longer meets the description of a reportable incident.Fda mdr reporting not required: the event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ based on medical advisor input stating fever and infection requiring antibiotic treatment is associated with severity +3 and no device malfunction has been identified.

Manufacturer Narrative

Pma/510(k) # k163468 supplemental report is being submitted as a cancellation report following the completion of the investigation as the complaint no longer meets the description of a reportable incident.Fda mdr reporting not required: the event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ based on medical advisor input stating fever and infection requiring antibiotic treatment is associated with severity +3 and no device malfunction has been identified.Device evaluation: the 11x 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 11 cases of fever and infection (ref att.¿lai - efficacy and safety of self-expandable metal stent.Pdf¿).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 - pr385311 abdominal pain - 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.Historical data review: as per d00059858 rev027 table 1; ¿historical data review¿ is not an investigation requirement for the complaint category type ¿adverse event¿.Instructions for use and/label review: as per the ifu (ifu0053), fever and infection are known potential adverse events associated with gi endoscopy ¿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 arrhythmia or arrest¿ 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 events.As per the ifu (ifu0053), both fever and infection are known potential adverse events 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, five patients in the primary group and six patients in the metastatic group had fever and infection 1 week after stent implantation.Confirmed quantity of 11 used devices.The investigation findings concluded a possible root cause of procedural adverse events.As per the ifu (ifu0053), both fever and infection are known potential adverse events associated with gi endoscopy.Complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patients experienced an adverse effect due to this occurrence.11 patients suffered fever and infection.The 05 patients in the primary group recovered well without other discomfort under anti-infection measures.04 in the metastatic group recovered well under anti-infection measures.The remaining 02 patients died from the following: one patient died of sudden cardiac arrest on the fifth day after stenting, and another patient died of septic shock because of an uncontrolled infection on the ninth day after stenting.Both cases of death were determined to be unrelated to the cook evolution duodenal device.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 16156599
• MDR Text Key: 308842539
• Report Number: 3001845648-2023-00026
• 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: 12/12/2023

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: 01/12/2023
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/09/2024
• 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