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

Catalog Number EVO-22-27-9-D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Alcala-gonzalez 2020 - endoscopic stenting for gastroduodenal outlet obstruction of a malignant origin, real life experience in a single center.An upper endoscopy was performed under conscious sedation, with a normal endoscope (gif-h180; olympus, tokyo, japan) to evaluate the obstruction of the lumen by the tumor.Two different techniques were used (fig.1).Fluoroscopy was not used if the stenosis allowed the passage of the endoscope.An endoscopic retrograde cholangiopancreatography (ercp) guidewire (acrobat® 2; cook medical, bloomington, indiana, usa) was positioned distal to the stenosis by direct observation.Fluoroscopy was used to guide the ercp guidewire distal to the stricture if the stenosis did not allow for endoscope progression.After guidewire insertion, water-soluble contrast was injected under fluoroscopic control to evaluate the duodenal anatomy and then a therapeutic upper endoscope (gif-xtq160; olympus, tokyo, japan) was used.The stenosis was reached with the guidewire through the working channel.Two types of usems were used due to the availability in our center.The hanaro® m.I.Tech stent, 22 mm-23 mm-11 cm was used from september 2013 to february 2016.From march 2016 to may 2018, the evolution® cook medical, 22 mm-27 mm-9 cm was used.The stent catheter was advanced over the guidewire and was released under direct visual examination and fluoroscopic control.Additional therapy was offered to three patients due to partial occlusion of the stent, one was successfully treated with another usems, one patient had a gastrojejunostomy and another had a radiological stent placement.One patient developed cholangitis complicated with a hepatic abscess.Patient outcome: e.Require intervention/additional procedures s=4.Patient/event info - notes: average age 68 years.Male: 20 female: 16.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 16-mar-2023.

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation: the 4x evo-22-27-9-d devices of unknown lot number involved in this complaint were implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created from the attached journal article to capture 3 cases of occlusion and 1 case of cholangitis.The following files were also raised from this journal article: ¿ 386244 - alcala-gonzalez 2020 - user error.¿ 386246 - alcala-gonzalez 2020 - migration.¿ 386247 - alcala-gonzalez 2020 - stent failure and occlusion.Lab evaluation: the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document 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.Ifu & label review: as per ifu0053-10, stent occlusion is a known adverse event ¿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).¿ as per medical advisor¿s clinical input, cholangitis is a known potential adverse event.It was observed in the literature paper that the user did not use fluoroscopic control if the stenosis allowed the passage of the endoscope "fluoroscopy was not used if the stenosis allowed the passage of the endoscope." this user-error situation will be captured under (b)(4).There is no evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined from the available information.However, both the stent occlusion and cholangitis reported in the literature article are known adverse events as per the ifu and medical advisor¿s input respectively.Summary: the complaint is confirmed based on customer testimony.According to the journal article, additional therapy was offered to three patients due to partial occlusion of the stent, one was successfully treated with another usems, one patient had a gastrojejunostomy and another had a radiological stent placement.One patient developed cholangitis complicated with a hepatic abscess.According to clinical input, all 04 patients required a form of reintervention/additional procedures.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: 16371155
• MDR Text Key: 309483108
• Report Number: 3001845648-2023-00097
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

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: EVO-22-27-9-D
• 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: 01/16/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 04/13/2023
• 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: 68 YR
• Patient Sex: Male