MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; MQR STENT, COLONIC METALLIC EXPANDABLE

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 04/22/2018

Event Type  Injury  

Manufacturer Narrative

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.The use of two cook evolution devices were mentioned as being used in this literature review; cook evolution duodenal and cook evolution colonic, based on clinical input it was presumed for these instances where perforation occurred that an evo -c could have been used.However due to limited information this cannot be confirmed therefore this is a conservative assessment.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 (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'.Adverse events included perforation related to the stenting procedure.Perforation was defined clinically, endoscopically and/or imagiologically as the presence of intra-abdominal extraluminal free air only apparent after the procedure of stent delivery.Stent dysfunction and adverse events are described in table 4.Perforation occurred in four (2.5%) procedures, all occurring in patients with carcinomatosis (p = 0.039).In one patient, the obstruction was caused by a recurrence of gastric cancer in an anastomosis site.The other three had obstruction caused by extraluminal compression by carcinomatosis.One patient in the jejunum; one patient in the antrum; one patient in the sigmoid colon.Both evo d and evo c are mentioned in this study however based on clinical input it was presumed for these instances where perforation occurred that an evo -c could have been used.However due to limited information this cannot be confirmed therefore 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

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), '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.The use of two cook evolution devices were mentioned as being used in this literature review; cook evolution duodenal and cook evolution colonic, based on clinical input it was presumed for these instances where perforation occurred that an evo -c could have been used.However due to limited information this cannot be confirmed therefore this is a conservative assessment.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.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 to address four cases perforation in occurring in patients.Due to limited information provided in this literature, we cannot confirm if the evo stents used were evolution colonic stent or evolution duodenal stent system.Documents review including ifu review: as the evo (evolution colonic or duodenal stent system) devices from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo 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 ifu0052-10 (evolution colonic stent) 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 ifu0053-10 (evolution duodenal stent system) which informs the user about the potential complications "additional complications include, but are not limited to : perforation, hemorrhage, aspiration, reflux, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Additional complications include but are not limited to: pancreatitis, intestinal perforation, pain, inadequate expansion, stent misplacement and/or migration, tumor ingrowth or overgrowth, sent occlusion, ulcerations, pressure necrosis, erosion of the luminal mucosa, septicemia, foreign body sensation, bowel impaction, death (other 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 due to limited information provided in this literature.From information provided "perforation is a major adverse event that has to be considered when considering stent placement.Previous studies have shown iatrogenic perforation rates of 0¿5% [11,13,18¿23].In our study population, perforation was a rare event, occurring in four (2.5%) of our patients.In all patients, carcinomatosis was present, being a predictive factor for this adverse event(p 0.039).In addition, all the four perforation cases occurred in patients with previous treatments, suggesting that this may be a risk factor for this complication, similar to other studies [24,25].Therefore, in experienced hands, intra-abdominal stent placement may be a very safe and feasible procedure." a possible root cause could be attributed to patient condition related, as per instructions for use, perforation is listed as a potential complication 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.- attachment: [pais cunha et al 2018.Pdf].

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 (instituto português de oncologia do porto francisco gentil, e.P.E) between (b)(6) 2012 and (b)(6) 2017.'' 'in total, 160 patients had a palliative indication for stent placement and were considered for analysis'.Adverse events included perforation related to the stenting procedure.Perforation was defined clinically, endoscopically and/or imagiologically as the presence of intra-abdominal extraluminal free air only apparent after the procedure of stent delivery.Stent dysfunction and adverse events are described in table 4.Perforation occurred in four (2.5%) procedures, all occurring in patients with carcinomatosis (p = 0.039).In one patient, the obstruction was caused by a recurrence of gastric cancer in an anastomosis site.The other three had obstruction caused by extraluminal compression by carcinomatosis.One patient in the jejunum; one patient in the antrum; one patient in the sigmoid colon.Both evo d and evo c are mentioned in this study however based on clinical input it was presumed for these instances where perforation occurred that an evo -c could have been used.However due to limited information this cannot be confirmed therefore 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), '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.

• Brand Name: UNKNOWN
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9564562
• MDR Text Key: 189318831
• Report Number: 3001845648-2020-00016
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

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?: No
• 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: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention