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

Catalog Number UNKNOWN

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

Patient Problems Perforation (2001); Septic Shock (2068)

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.Perforation due to stent placement (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.

Event Description

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

Manufacturer Narrative

Pma/510(k) # k163468.Device evaluation: the 01x evolution® colonic controlled-release stent - uncovered device of unknown lot number and rpn involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file was created in response to the journal article ¿amelung 2016 - deviating colostomy construction versus stent placement as bridge to surgery for malignant left-sided colonic obstruction¿ to capture 01x cases of perforation due to stent placement.The following were also raised in response to this pmcf study/journal article: ¿ pr (b)(4) ¿ ¿amelung 2016 ¿ stent obstruction caused by fecal debris¿ ¿ pr (b)(4) ¿ ¿amelung 2016 ¿ stent migration¿ 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 (ifu0052), perforation and septicaemia are both known potential adverse event associated with gi endoscopy ¿those associated with gi endoscopy include, but are not limited to: perforation, hemorrhage, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.¿ ¿additional adverse events 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, septicemia, foreign body sensation, bowel impaction, diarrhea, 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 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 known procedural adverse events and/or patients pre-existing conditions.According to the medical advisor's input, both intestinal perforation and septicemia in this study can be possibly root caused to the stent, the stent placement procedure and/or the patient's pre-existing conditions.As mentioned above, both perforation and septicaemia are listed as known adverse events listed within the instruction's for use "potential complications" section.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Confirmed quantity of 01x used devices.Summary of investigation: according to the journal article, the patient did experience adverse effects due to this occurrence.Regarding the patient mortality in the study, as per clinical input, ¿one 30-day mortality occurred in sems group due to an abdominal sepsis secondary to a perforation occurred in one patient treated with sems.It was impossible to determine which stent was being used.Again, the type of the perforation and if the perforation caused direct patient¿s death were unknown.¿ therefore, it is not definitive that the cook evolution colonic stents listed in this journal article caused or contributed to the mortality documented.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 18443462
• MDR Text Key: 331881923
• Report Number: 3001845648-2024-00001
• 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