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

Catalog Number	ZIB6-125-14.0-60
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow up report will sent within 30 days following the completion of the investigation.
Event or Problem Description
The stent did not deploy uniformly.The stent remained where placed and did not straighten post dilation.
Additional Manufacturer Narrative
(b)(4) device of lot c1234857 was implanted in the patient and was not returned for evaluation.From the information provided, a document based investigation was carried out.From the customer testimony, the patient did not have a calcified anatomy, but did exhibit some tortuosity.The patient had pre-existing venous disease.The device was implanted in the iliac vein.There was no deployment difficulties reported.The stent remained inside the patient, and no additional procedures were required as a result of this occurrence.Imaging of the implanted stent (x-ray, ct scan, angiography etc.) were not available at the time of investigation.There is no evidence that this incident did not occur.Therefore, the customer complaint is confirmed based on the customer testimony.A possible root cause for this occurrence could be the tortuous patient anatomy.In addition, zilver 635 biliary stents are indicated for use in the biliary tree.As per customer testimony, the stent was implanted in the iliac vein.Implanting the stent in a non-indicated location may have contributed to the stent deformation.However, the conditions of use cannot be replicated in the laboratory environment, imaging is unavailable and the device was not available for evaluation.Therefore, a definitive root cause of this event cannot be determined.As per product ifu, under the intended use section: ¿the zilver 518 and 635 biliary stents are intended for palliation of malignant neoplasms in the biliary tree.¿ all zib6 (zilver 635 biliary) devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records for this lot 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 available to date, there is no evidence to suggest that there are any manufacturing issues associated with this lot number.The patient did not experience any adverse effects due to this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
This follow up report is being submitted due to the conclusion of the investigation into this event.Event description submitted as follows: the stent did not deploy uniformly.The stent remained where placed and did not straighten post dilation.

• Brand Name: ZILVER 635 BILIARY SELF-EXPANDING STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6035889
• Report Number: 3001845648-2016-00294
• Device Sequence Number: 10849739
• Product Code: FGE
• UDI-Device Identifier: 10827002362458
• UDI-Public: (01)10827002362458(17)190527(10)C1234857
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2016

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 Catalogue Number: ZIB6-125-14.0-60
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2016
• Supplement Report FDA Received Date: 11/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1