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

Catalog Number EVO-FC-R-20-25-12-E

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

510(k) number is: k162717.This specific evolution device is currently not registered for sale in the us.However, this device is considered 'similar' to other metal biliary stents/sets (evolution) devices currently marketed in the us.The 510(k) number provided is of the device considered "similar".(b)(4).Information pertaining to as follows: (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This file is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿deployment issue that results in the exposed stent removed from the patient with the delivery system¿.The stent could not be released.Additional information received: was the directional button fully engaged? yes.Did the red indicator move when the trigger was pressed? yes.Did the red indicator continue to move after the delivery stopped? no.Were any cracking/popping sounds heard from the handle? yes.Was the stent partially exposed? yes.If the stent was partially exposed, was it possible to recapture the stent fully before removal? no.Were any additional procedures needed? no.

Manufacturer Narrative

510(k) number is: k162717.This specific evolution device is currently not registered for sale in the us.However, this device is considered 'similar' to other metal biliary stents/sets (evolution) devices currently marketed in the us.The 510(k) number provided is of the device considered "similar." cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6); cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).The device involved in the complaint was evaluated in the laboratory on 12th december 2018 and re-evaluated on the 16th january 2019.No defect related to complaint found in the laboratory.The handle and introducer system movement in full working order.Stent was already released.Kink visible on the device, possibly due to transportation of the device back to cir and has no impact, as the stent was released.Following the laboratory evaluation additional information was requested to elaborate on question if the stent released.Complaint description is that the stent could not be released, however the stent was returned separately.Second complaint file was raised to address the kink, observed during laboratory evaluation.Documents review including ifu review: prior to distribution all evo-fc-r-20-25-12-e devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-fc-r-20-25-12-e device of lot number c1402106 id not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1402106; upon review of complaints this failure mode has not occurred previously with this lot #c1402106.The instructions for use (b)(4) which accompanies this device instructs the user to "¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use." there is no evidence to suggest that the customer did not follow the instructions for use (b)(4).Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to a patient anatomy.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This file is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿deployment issue that results in the exposed stent removed from the patient with the delivery system.¿ the stent could not be released.Additional information received: was the directional button fully engaged? yes.Did the red indicator move when the trigger was pressed? yes.Did the red indicator continue to move after the delivery stopped? no.Were any cracking/popping sounds heard from the handle? yes.Was the stent partially exposed? yes.If the stent was partially exposed, was it possible to recapture the stent fully before removal? no.Were any additional procedures needed? no.

Event Description

This file is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿deployment issue that results in the exposed stent removed from the patient with the delivery system¿.The stent could not be released.Additional information received: was the directional button fully engaged? yes.Did the red indicator move when the trigger was pressed? yes.Did the red indicator continue to move after the delivery stopped? no.Were any cracking/popping sounds heard from the handle? yes.Was the stent partially exposed? yes.If the stent was partially exposed, was it possible to recapture the stent fully before removal? no.Were any additional procedures needed? no.

Manufacturer Narrative

510(k) number is: k162717.This specific evolution device is currently not registered for sale in the us.However, this device is considered 'similar' to other metal biliary stents/sets (evolution) devices currently marketed in the us.The 510(k) number provided is of the device considered "similar" cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8169019
• MDR Text Key: 131781504
• Report Number: 3001845648-2018-00590
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002551722
• UDI-Public: (01)10827002551722(17)190920(10)C1402106
• 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,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2019
• Device Catalogue Number: EVO-FC-R-20-25-12-E
• Device Lot Number: C1402106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/17/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 11/20/2018; 11/20/2018
• Supplement Dates FDA Received: 01/14/2019; 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1