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

Catalog Number UNKNOWN

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: k162717 and k093619.As the exact rpn is unknown 510k#'s for both fully and partially covered evolution devices have been provided.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: "in one patient with a benign proximal stricture, the diameter of the deployed stent was too small to completely cover the fistulous open, therefore ultimately requiring the stent to be exchanged for a stent with a larger diameter.This file has been opened to capture the user error associated with the incorrect size stent used and the subsequent intervention performed as a result." 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 the patient required the stent to be exchanged for a stent with a larger diameter.

Manufacturer Narrative

Pma/510(k)#: k162717.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 user error- stent diameter too small.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 precautions: "a complete diagnostic must be performed prior to use to determine proper stent size".On review of the information provided, there is evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause could be determined from the available information.A definitive root cause could be attributed to user error, as per details given in the article "the diameter of the deployed stent was too small to completely cover the fistulous open, therefore ultimately requiring the stent to be exchanged for a stent with a lager diameter".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.

Event Description

Complaint received from internal personnel via e-mail on 03dec2019--did 04dec2019.As reported to customer relations: "in one patient with a benign proximal stricture, the diameter of the deployed stent was too small to completely cover the fistulous open, therefore ultimately requiring the stent to be exchanged for a stent with a larger diameter.This file has been opened to capture the user error associated with the incorrect size stent used and the subsequent intervention performed as a result." 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 the patient required the stent to be exchanged for a stent with a larger diameter.

• Brand Name: UNKNOWN
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9494261
• MDR Text Key: 188933095
• Report Number: 3001845648-2019-00755
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

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: 12/23/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention