MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; MUM STENT, METALIC EXPANDABLE, DUODENAL

Catalog Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422); No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2018

Event Type  Injury  

Manufacturer Narrative

This file is being opened to capture evo-22-27-6-d and evo-25-30-6-c (7 cases stent migration).Although due to limited information it cannot be confirmed if this exact rpn is related to the migration.This is a conservative assessment.Due to limited information provided in this literature, we cannot confirm if the evo stents used were evo d or evo c.As per 'medical device reporting for manufacturer¿s (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.Please see below for details of common name and 510k #: cook evolution duodenal - mum - mum stent, metallic expandable, duodenal.Cook evolution colonic - mqr - mqr stent, colonic metallic expandable.Both evolution stents have the same 510k number: k163468.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As per source doc: literature review title: ''endoscopic stenting for palliation of intra-abdominal gastrointestinal malignant obstruction: predictive factors for clinical success'' pais-cunha et al 2018.As per lit review this study aimed to analyse the factors predicting the effectiveness of stent placement in patients with gastrointestinal obstruction.It was a retrospective study that was carried out including 160 patients who underwent palliative stenting for intra-abdominal obstruction, technical and clinical success, stent dysfunction and adverse events were analysed.''we carried out a retrospective study of a consecutive series of patients undergoing either gastroduodenal or colorectal stent placement for the treatment of malignant intra-abdominal gastroduodenal or colonic obstruction in a tertiary-care medical centre centre (instituto português de oncologia do porto francisco gentil, e.P.E)) between december 2012 and july 2017.'' 'in total, 160 patients had a palliative indication for stent placement and were considered for analysis.' stent dysfunction occurred in 21 (13%) patients, seven (15%) patients who had undergone colorectal stent placement and 14 (13%) patients who had undergone gastroduodenal stent placement (p = 0.731).Migration was associated with short 6 cm stents (9 vs.2% p = 0.044).Table 2 shows 7 cases of stent migration.This file is being opened to capture evo-22-27-6-d and evo-25-30-6-c (7 cases stent migration).Although due to limited information it cannot be confirmed if this exact rpn is related to the migration.This is a conservative assessment.Due to limited information provided in this literature, we cannot confirm if the evo stents used were evo d or evo c.As per 'medical device reporting for manufacturer¿s (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.

Event Description

As per source doc: literature review title: ''endoscopic stenting for palliation of intra-abdominal gastrointestinal malignant obstruction: predictive factors for clinical success'' pais-cunha et al 2018.As per lit review this study aimed to analyse the factors predicting the effectiveness of stent placement in patients with gastrointestinal obstruction.It was a retrospective study that was carried out including 160 patients who underwent palliative stenting for intra-abdominal obstruction, technical and clinical success, stent dysfunction and adverse events were analysed.''we carried out a retrospective study of a consecutive series of patients undergoing either gastroduodenal or colorectal stent placement for the treatment of malignant intra-abdominal gastroduodenal or colonic obstruction in a (b)(6) medical centre ((b)(6) ) between december 2012 and july 2017.'' 'in total, 160 patients had a palliative indication for stent placement and were considered for analysis' stent dysfunction occurred in 21 (13%) patients, seven (15%) patients who had undergone colorectal stent placement and 14 (13%) patients who had undergone gastroduodenal stent placement (p = 0.731).Migration was associated with short 6 cm stents (9 vs.2% p = 0.044).Table 2 shows 7 cases of stent migration.This file is being opened to capture evo-22-27-6-d and evo-25-30-6-c (7 cases stent migration).Although due to limited information it cannot be confirmed if this exact rpn is related to the migration.This is a conservative assessment.Due to limited information provided in this literature, we cannot confirm if the evo stents used were evo d or evo c.As per 'medical device reporting for manufacturer¿s (2016), section 4.16.2 'submit an individual report for each device identified if the generic names of the devices are different.' therefore, one report will be submitted in relation to the above serious injury.

Manufacturer Narrative

Cook evolution duodenal - mum - mum stent, metallic expandable, duodenal.Cook evolution colonic - mqr - mqr stent, colonic metallic expandable.Both evolution stents have the same 510k number: k163468.Device evaluation: the evo stents of unknown lot number were not returned to cook ireland for evaluation.With the information provided, document based investigation was conducted.This file was created from the attached journal article.A retrospective study was carried out including 160 patients.The diameter of the stents varied from 22 to 27mm and length varied from 6, 9 to 12 cm [boston wallstent (boston scientific, marlborough, massachusetts, usa) and cook evolution duodenal or colonic stents (cook medical, bloomington, indiana, usa)] depending on the patients¿ conditions and obstructive causes.This file was created from the attached journal article to address seven cases of stent migration.Documents review including ifu review: as the evo devices from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo (evolution colonic stent and evolution duodenal stent ) devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The instructions for use (b)(4) (for evolution colonic stent system) which informs the user about the potential complications "additional complications include, but are not limited to : perforation, hemorrhage, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Additional complications include but are not limited to: intestinal perforation, pain, inadequate stent expansion, stent misplacement and/or migration, tumor 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).The instructions for use (b)(4) (for evolution duodenal stent system) which informs the user about the potential complications: those associated with gi endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, reflux, fever, infection, allergic reaction to medication, hypopotension, respiratory depression or arrest, cardiac arrythmia or arrest.Additional complications include, but are not limited to: pancreatitis, intestinal perforation, pain, indadequate expansion, stent misplacement and/or migration, tumor ingrowth or overgrowth, stent occlusion, ulcerations, pressure necrosis, erosion of the luminal muscosa, septicemia, foreign body sensation, bowel impaction, death (other than due to normal disease progression).There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.Information received is not sufficient enough to confirm that it was the cook stent that contributed to the event.Therefore risk will not be complete due to the limitation of available information.A possible root cause could be attributed to patient condition related, as per instructions for use, stent migration is listed as a potential complications following the placement of this device.Summary: customer complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: UNKNOWN
• Type of Device: MUM STENT, METALIC EXPANDABLE, DUODENAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9564613
• MDR Text Key: 189445805
• Report Number: 3001845648-2020-00019
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

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: 04/22/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention