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

Catalog Number	ZIB6-125-5.0-40
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 1 x zib6-125-5.0-40 device of lot number c1204202 has not yet been returned for evaluation.With the information provided a document based investigation was carried out.From information provided it is known that no portion of the device remained inside the patient, no additional procedures were required and the patient experienced no adverse effects as a result of this occurrence.Additional information was requested, but at the time of investigation this information was not available there is no evidence to suggest that this event did not occur therefore the complaint is confirmed based on customer testimony.Additional information was not provided, the device has not yet been returned for evaluation, and the conditions of use cannot be replicated in a laboratory environment.Therefore, a definitive root cause for this occurrence cannot be determined, and no further comment can be made.The investigation will be updated once the complaint device has been made available for evaluation, or additional information is provided by the customer.Prior to distribution all 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 that could have contributed to this 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.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
It was reported that the device would not properly deploy; stays closed at one end.The delivery system and stent were removed from patient together, and another device was used to complete the procedure.
Additional Manufacturer Narrative
The zib6-125-5.0-40 device of lot number c1204202 was returned for evaluation with the original packaging.The packaging was open on receipt.With the information provided a physical examination and document based investigation was carried out.From information provided it is known that no portion of the device remained inside the patient, no additional procedures were required and the patient experienced no adverse effects as a result of this occurrence.Additional information was requested, but at the time of investigation this information was not available.On evaluation of the returned device, it was observed that the flexor was pulled out of the connector cap.The stent was deployed during the evaluation, and was found to be the correct size.The overall device length was measured as 125cm, which was within specification of 125cm +1.3cm -0.8cm.The customer complaint is confirmed as the flexor was found separated from the handle at the white connector cap.Possible root causes for this occurrence could include difficult patient anatomy, which could cause high deployment forces.These forces could cause or contribute to the flexor detaching from the handle.However, additional information was not provided and the conditions of use cannot be replicated in a laboratory environment.Therefore, a definitive root cause for this occurrence cannot be determined.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 that could have contributed to this 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 lot number.According to complaint information, the patient did not require any additional procedures or 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
A follow-up mdr is being submitted to include the device evaluation details.Initial report details: it was reported that the device would not properly deploy; stays closed at one end.The delivery system and stent were removed from patient together, and another device was used to complete the procedure.

• 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: 6232510
• Report Number: 3001845648-2017-00006
• Device Sequence Number: 16408361
• Product Code: FGE
• UDI-Device Identifier: 10827002320328
• UDI-Public: (01)10827002320328(17)190225(10)C1204202
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ZIB6-125-5.0-40
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR