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

Catalog Number UNKNOWN

Device Problems Activation Failure (3270); Unclear Information (4052)

Patient Problems Failure of Implant (1924); Obstruction/Occlusion (2422)

Event Date 04/22/2018

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.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 common name for evo - d is mum stent, metalic expandable, duodenal and product code is mum, while the common name for evo - c is mqr stent, colonic metallic expandable and product code is mqr.Referencing both as unclear as whether it related to evo c or evo d.They both have the same pma/510(k) #: k163468.

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'.Technical success was achieved in 157 (98%) patients.In three patients, successful stent placement was only achieved in a second procedure, but was considered a technical success.Please note: 2 different brands of stent were used in this paper as follows '' [boston wallstent (boston scientific, marlborough, massachusetts, usa) and cook evolution duodenal or colonic stents (cook medical, bloomington, indiana, usa)]'' therefore we cannot verify that the cook evolution stent was related to this specific event, 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."three patients who had to have a second procedure to achieve successful stent placement".

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".Technical success was achieved in 157 (98%) patients.In three patients, successful stent placement was only achieved in a second procedure, but was considered a technical success.Please note: 2 different brands of stent were used in this paper as follows '' [boston wallstent (boston scientific, marlborough, massachusetts, usa) and cook evolution duodenal or colonic stents (cook medical, bloomington, indiana, usa)]'' therefore we cannot verify that the cook evolution stent was related to this specific event, 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."three patients who had to have a second procedure to achieve successful stent placement".

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 common name for evo - d is mum stent, metalic expandable, duodenal and product code is mum, while the common name for evo - c is mqr stent, colonic metallic expandable and product code is mqr.Referencing both as unclear as whether it related to evo c or evo d.They both have the same pma/510(k) #: k163468.Due to limited information provided in this literature, we cannot confirm if the evo stents used were evo d or evo c.Device evaluation: the evo stents (evolution colonic stent system or evolution duodenal stent system) 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 three cases stent placement requiring second procedure.As per medical advisor input ".Because the first procedures in 3 patients were not successful, the ¿continuation of occlusion¿ was still there but which can be treated within the same procedure, therefore the severity is +3." 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 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 (for evolution colonic stent system) which informs the user about the contradictions listed: "additional contraindications include, but are not limited to : enteral ischemia, suspected or impending perforation, intra-abdominal abscess/perforation, inability to pass wire guide or stent through obstructed area, patients for whom endoscopic procedures are contraindicated, significant coagulopathy, benign disease.The instructions for use ifu0053-10 (for evolution duodenal stent system) which informs the user about the contradictions listed: "additional contraindications include, but are not limited to : enteral ischemia, suspected or impending perforation, intra-abdominal abscess/perforation, inability to pass wire guide or stent through obstructed area, patients for whom endoscopic procedures are contraindicated, coagulopathy/patients with elevated times, benign disease.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 "technical success was achieved in 157 (98%) patients.In three patients, successful stent placement was only achieved in a second procedure, but was considered a technical success.Technical failure occurred in three cases because the guidewire could not pass through the stenosis site (one in a gastroduodenal obstruction and two in colorectal obstructions).In all cases of technical failure, the obstruction was caused by carcinomatosis.The three patients in whom technical success was not achieved were excluded from further analysis." a possible root cause could be attributed to patient condition related, as per instructions for use, tumor ingrowth or overgrowth, stent occlusion, are listed as a potential complications following the placement of this device.Summary: customer complaint is confirmed based on customer testimony.The patient was requiring second stent placement.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: 9564461
• MDR Text Key: 189316769
• Report Number: 3001845648-2020-00015
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

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: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention