MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; ESW PROSTHESIS, ESOPHAGEAL

Catalog Number UNKNOWN

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

Patient Problem Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

Complaint received from internal personnel via e-mail on 03dec2019--did 04dec2019.As reported to customer relations: "adverse events occurred in 6/14 (42.9%) patients with a malignant fistula and in 4/11 (36.4%) patients with a benign fistula.1 case of pneumonia." 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 as per clinical input this patient likely required intervention and the pneumonia is assessed by clinical as device related based on infection as the worst case scenario.

Manufacturer Narrative

This event meets the requirements of a serious injury report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 ".A ¿serious injury¿ is an injury or illness that: ¿necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure¿ and section 2.5 "it should also be noted that a device does not have to malfunction for it to cause or contribute to a serious injury".Device evaluation: the evo 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.A total of twenty five patients were identified in this retrospective study of 35 procedures over an 8-year period.The stents used were as follows: 11endomaxx (merit), 11 wallflex (boston scientific), 5 polyflex (boston scientific), and 3 evolution cook endoscopy) were used.This file captures pneumonia.(ref.Att."silon 2017.Pdf").Due to the limited information provided in this literature, we cannot confirm if the evo stent's used were partially/ fully covered and used for benign or malignant indication.Lab evaluation: n/a.Documents review including ifu review: as the evo stent is unknown device from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution all evo (partially and fully covered esophageal 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.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.Image review: n/a.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, fever, infection, are 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.Attachment: [silon 2017.Pdf].

Event Description

As reported to customer relations: "adverse events occurred in (b)(6) (42.9%) patients with a malignant fistula and in 4/11 (36.4%) patients with a benign fistula.1 case of pneumonia.".

• Brand Name: UNKNOWN
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9494486
• MDR Text Key: 189145232
• Report Number: 3001845648-2019-00766
• 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
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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
• Event Location: Hospital
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention