MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

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

Patient Problem Death (1802)

Event Date 06/13/2016

Event Type  Death  

Manufacturer Narrative

K162717 - exact rpn unknown therefore this is the most likely us clearance number.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.[(b)(4)].

Event Description

Literature review title: ''early pain detection and management after esophageal metal stent placement in incurable cancer patients: a prospective observational cohort study'' reijm et al 2016.Sixty-five patients were treated with a sems for a malignant stricture of the esophagus (n=58) or gastric tube (n=7), including 6 patients with a concomitant fistula.''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).1 death due to probable upper gastrointestinal bleeding.As per medical advisor ''5 types of stents were used in this study, it is not possible to confirm if cook stent caused this probable upper gastrointestinal bleeding.'' ''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).We cannot confirm that the cook evolution stent was related to this specific adverse event so this is a conservative assessment.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.Due to 1 death due to probable upper gastrointestinal bleeding.

Manufacturer Narrative

As the exact rpn is unknown the most likely us clearance number k16271.The device evaluation was updated on 26-may-2020, please see below.Device evaluation: the evo (evolution® esophageal controlled-release stent - partially covered) device of unknown lot number was 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, where five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).This file captures one death due to probable upper gastrointestinal bleeding (ref.Att."reijm 2016.Pdf") documents review including ifu review: as the evo (evolution® esophageal controlled-release stent - partially covered) device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo(evolution® esophageal controlled-release stent - partially covered 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.As per the instructions for use, ifu0061-5, 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 complication include, but are not limited to: stent misplacement and/or migration; tumor ingrowth or overgrowth; esophageal ulceration and erosion; nausea; chest or retrosternal pain; foreign body sensation; food bolus impaction; gasbloat; sensitivity to metal components; fistula involving trachea, bronchi or pleural space; intestinal obstruction secondary to migration; mediastinitis or peritonitis; airway compression; tracheal obstruction.On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.As per medical advisor ''the information of this article is not sufficient enough to confirm that cook stent caused patient death.Furthermore, some of the stents among other 4 types of stent have sharper flange and more rigid radial force when comparing cook stent." therefore due to limited information available it cannot be confirmed that cook stent caused the patient death.Summary: complaint is confirmed based on the customer¿s testimony.According to the initial reporter, 1 death due to probable upper gastrointestinal bleeding.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to a correction applied to the investigation conclusions.Complaint is confirmed.

Event Description

Literature review title: ''early pain detection and management after esophageal metal stent placement in incurable cancer patients: a prospective observational cohort study'' reijm et al 2016 sixty-five patientswere treated with a sems for amalignant stricture of the esophagus (n=58) or gastric tube (n=7), including 6 patients with a concomitant fistula.''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).(b)(4) death due to probable upper gastrointestinal bleeding.As per medical advisor ''5 types of stents were used in this study, it is not possible to confirm if cook stent caused this probable upper gastrointestinal bleeding.'' ''five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).We cannot confirm that the cook evolution stent was related to this this specific adverse event so this is a conservative assessment.

Manufacturer Narrative

As the exact rpn is unknown the most likely us clearance number k16271.Device evaluation: the evo (evolution® esophageal controlled-release stent - partially covered) device of unknown lot number was 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, where five stent types were used: partially covered ultraflex stents (boston scientific), partially covered evolution stents (cook medical), fully covered hanaro stents (mi tech) and partially as well as fully covered wallflex stents (boston scientific).This file captures one death due to probable upper gastrointestinal bleeding documents review including ifu review: as the evo (evolution® esophageal controlled-release stent - partially covered) device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo(evolution® esophageal controlled-release stent - partially covered 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.As per the instructions for use, ifu0061-5, 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 complication include, but are not limited to: stent misplacement and/or migration; tumor ingrowth or overgrowth; esophageal ulceration and erosion; nausea; chest or retrosternal pain; foreign body sensation; food bolus impaction; gasbloat; sensitivity to metal components; fistula involving trachea, bronchi or pleural space; intestinal obstruction secondary to migration; mediastinitis or peritonitis; airway compression; tracheal obstruction.On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.As per medical advisor ''the information of this article is not sufficient enough to confirm that cook stent caused patient death.Furthermore, some of the stents among other 4 types of stent have sharper flange and more rigid radial force when comparing cook stent." therefore due to limited information available it cannot be confirmed that cook stent caused the patient death.Summary: the complaint is not confirmed as the event is not considered to be device related due to limited information available.According to the initial reporter, 1 death due to probable upper gastrointestinal bleeding complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9535342
• MDR Text Key: 173209931
• Report Number: 3001845648-2019-00780
• Device Sequence Number: 1
• Product Code: ESW
• 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,Followup
• Report Date: 05/26/2020

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: 06/13/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 12/05/2019; 12/05/2019
• Supplement Dates FDA Received: 02/21/2020; 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death