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

Model Number G48031

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This file is being reported under the fda mdr malfunction precedence "stent not expanding/opening post deployment".As reported to customer relations: "physician is well-versed in placing.Measured stricture, chose size.Placement of stent went smoothly, except on the proximal end the stent would not open.Appeared to have a tangled lasso loop, per physician.Physician determined to use another stent over same location, performed this without issue.Patient was fine, no adverse effects.2nd device was another cook stent, unknown beyond that.

Event Description

This file is being reported under the fda mdr malfunction precedence "stent not expanding/ opening post deployment".As reported to customer relations: "physician is well-versed in placing.Measured stricture, chose size.Placement of stent went smoothly, except on the proximal end the stent would not open.Appeared to have a tangled lasso loop, per physician.Physician determined to use another stent over same location, performed this without issue.Patient was fine, no adverse effects.2nd device was another cook stent, unknown beyond that.

Manufacturer Narrative

510(k) number is k162717.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)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.The evo-20-25-10-e device of lot number c1431892 involved in this complaint was not returned for evaluation.With the information provided a document based investigation was conducted.Prior to distribution all evo-20-25-10-e devices are subject to visual inspection and functional checks to ensure device integrity.There inspections and functional checks are outlined in internal procedures in place at cirl a review of the qc records did not reveal any discrepancies which could have contributed to this complaint issue.Upon review of complaints, this failure mode has not occurred previously with the lot number c1431892.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1431892.A review of the manufacturing records for lot number c1431892 did not reveal any discrepancies which could have contributed to this complaint issue.As per the instructions for use, ifu0061-5, notes section the user is instructed of the following: "there is a lasso at the proximal end of the stent, purpose is to reposition the stent in the event of incorrect placement." and ¿to reposition stent directly after placement, grip the stainless steel/white lasso at proximal end of stent with forceps and reposition stent to desired area".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0061-5).Upon further review additional information was requested to confirm if the lasso loop was preventing release and confirm if the stent was released from the delivery system.As per customer testimony "from what i recall the stent released with no problem.The problem occurred when the stent was released it would not open up." root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to that the lasso loop got caught on the bilumen.Summary: complaint is confirmed based on the customer¿s testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.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: 8115680
• MDR Text Key: 129587851
• Report Number: 3001845648-2018-00558
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)191213(10)C1431892
• 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: 11/29/2018

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: 12/13/2019
• Device Model Number: G48031
• Device Catalogue Number: EVO-20-25-10-E
• Device Lot Number: C1431892
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/29/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/29/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1