MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Catalog Number UNKNOWN

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Amelung, 2016 ¿ deviating colostomy construction versus stent placement as bridge to surgery for malignant left-sided colonic obstruction.All patients underwent the initial decompression procedure within 48 h after presentation with obstructive symptoms.The gastrointestinal surgeon on call performed the colostomy constructions, while sems placement was performed by one of three expert endoscopists with a minimum of 4-year experience ([20 procedures) with colonic stent placement.Colostomies were constructed on the right transverse colon.An incision was made in the right upper abdominal quadrant; the transverse colon was elevated to the skin, temporarily anchored with a plastic rod and fixed with resolvable stitches.Four different stent types were used, based on availability, i.E., wallstent _ (boston scientific, natrick, ma, usa), wallflex_ (boston scientific), ultraflex_ (boston scientific) and evolution_ (cook medical, limerick, ireland).After colostomy construction or stent placement, patients received enteral feeding as soon as possible.Elective resection was performed after approximately 2¿4 weeks.Six patients with technically successful stent placement did not have any relief of symptoms, due to: stent migration (n = 1).Patient outcome: require intervention/additional procedures s=4.Patient/event info - notes: as per fda guidance: average patient age and weight, as well as the gender of the majority of patients involved/individual patient info if available.

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation the device evaluation of evolution® colonic controlled-release stent ¿ uncovered of unknown lot number could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file was created from the attached journal article amelung 2016.Additional files listed were opened as a results of this paper: 417435- amelung 2016 - perforation 417437 - amelung 2016 ¿ stent obstruction caused by fecal debris 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 the instructions for use, ifu0052 which accompanies this device, states ¿additional complications include, but are not limited to: intestinal perforation, pain, inadequate stent 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 , diarrhoea , constipation, peritonitis, symptoms of tenesmus or urgency/incontinence , death( other than due to normal disease progression ¿¿ 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 analysis a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition, the instructions for use list stent migration as an additional complication.Is it known from the available information the stent was used to treat malignant colonic obstruction.Confirmation of complaint.Complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction complaints of this nature will continue to be monitored for similar events.Summary of investigation according to the literature stent migration was reported in 1 patient.Confirmed quantity of 1 device, confirmed used.The patient required intervention/additional procedures due to this occurrence.Investigation findings conclude a definitive root cause was established.A possible root cause could be attributed to patient condition.Complaints of this nature will continue to be monitored for similar events.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 20-may-2024.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• 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: 18443466
• MDR Text Key: 331881956
• Report Number: 3001845648-2024-00003
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/12/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/04/2024
• 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: 72 YR
• Patient Sex: Female