MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 BILIARY SELF-EXPANDING STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Catalog Number	ZIB6-125-14.0-80
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
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.The zib6-125-14.0-80 device of lot number c1304552 involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, it is known that the complaint device was implanted in the left iliac vein.The patient was reported to have pre-existing conditions, including obesity and sleep apnea.The customer was contacted to ask if images of the implanted stent were available.However, at the time of investigation, no images have been provided after three requests.The investigation will be updated if images are provided and evaluated.There is no evidence to suggest that this incident did not occur.Therefore, the customer complaint is confirmed based on customer testimony.Possible causes for this occurrence could include the use of the device in a non-indicated location.The customer reported that the zib6 (zilver biliary) stent was implanted in the left iliac vein.The non-indicated location could have caused or contributed to the stent migration.From the product instructions for use: ¿the zilver 518 and 635 biliary stents are intended for palliation of malignant neoplasms in the biliary tree¿.Prior to distribution, all zib6 (zilver biliary) devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing 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 this lot number.Based on the information provided to date, there is no evidence to suggest any manufacturing issues associated with lot number c1304552.According to the initial reporter, the patient required two open heart surgeries to remove the fractured portions of the migrated stent.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
Patient underwent elective stent procedure of left iliac vein on (b)(6) 2017.Patient returned to the er on (b)(6) 2017 with complaint of chest pain and shortness of breath, ct scan of chest revealed a venous stent in the right ventricle and a vascular coil in right pulmonary artery; patient to ir for retrieval of foreign body.Patient required open heart surgery to remove rest of foreign body in the right atrium.Open atriotomy on (b)(6) 2017: removal of the metallic stent pieces attached to the chordae tendinae and under side of the signal branch of the mitral valve inside the right ventricle.Update - spoke with risk manager - she confirmed that the coil referenced in the medwatch report is a terumo azur coil.She also confirmed that there were two intervention procedures.One in ir on (b)(6) 2017 where "a bunch" of stent fragments were retrieved and another on (b)(6) 2017 where the final two fragments were retrieved during an open atriotomy.

• Brand Name: ZILVER 635 BILIARY SELF-EXPANDING STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6539743
• Report Number: 3001845648-2017-00154
• Device Sequence Number: 16176448
• Product Code: FGE
• UDI-Device Identifier: 10827002362465
• UDI-Public: (01)10827002362465(17)191212(10)C1304552
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K051124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/04/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ZIB6-125-14.0-80
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/04/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 112