MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G23130
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/ stretched/ broken/compressed'.Stent not releasing during triggering could not be deployed.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/ stretched/ broken/compressed'.Stent not releasing during triggering could not be deployed.
Additional Manufacturer Narrative
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).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿flexor kinked/ stretched/ broken/compressed' and "deployment issue resulting in stent deployed in incorrect location'.Device was returned and evaluated on the 25-apr-19 confirming the stent was partially deployed on return.Stent not releasing during triggering could not be deployed.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).The device involved in the complaint was evaluated in the laboratory on 25th april 2019.No visual defect found in the laboratory.Stent deployed with high resistance possibly due to kink.When device and introducer was straighten out there was a great decrease in the resistance.Prior to distribution all evo-10-11-10-b 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 upon review of complaints, this failure mode has not occurred previously with the lot number c1335622.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1335622 a review of the manufacturing records for c1335622 did not reveal any discrepancies which could have contributed to this complaint issue.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0056-5).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 patient anatomy.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.A possible root cause could be attributed to patient anatomy.According to the information reported, there have been no adverse effects to the patient reported.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8420537
• Report Number: 3001845648-2019-00103
• Device Sequence Number: 11208817
• Product Code: FGE
• UDI-Device Identifier: 10827002231303
• UDI-Public: (01)10827002231303(17)190314(10)C1335622
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2019
• Device Model Number: G23130
• Device Catalogue Number: EVO-10-11-10-B
• Device Lot Number: C1335622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/14/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 02/14/2019; 02/14/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/11/2019; 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 43