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

Model Number	G36229
Medical Device Problem Codes	Fracture (1260); Delivery System Failure (2905)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Us clearance # k040505 k163169.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 investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.
Event or Problem Description
Initial mdr is being submitted based on the device malfunction precedence: ¿flexor breaking during deployment (incl.Flexor/handle separation" and "stent fracture".As reported to customer relations: "while unsheathing catheter for stent deployment, outer catheter snapped, while inner portion of catheter remained intact.(catheter & unsheathing mechanism both flushed with saline prior to use).Stent kinked & then fell apart.Needed to use a new stent, which was deployed successfully." additional information provided by dm on (b)(6) 2018: "the midpart of the flexor sheath kinked, the physician could not deploy the stent inside the patient, the flexor sheath unraveled at the part of the kink (you will see this when the device is returned).".
Event or Problem Description
Mdr submitted based on the device malfunction precedence: ¿flexor breaking during deployment (incl.Flexor/handle separation" and "stent fracture" as reported to customer relations: "while unsheathing catheter for stent deployment, outer catheter snapped, while inner portion of catheter remained intact.(catheter & unsheathing mechanism both flushed with saline prior to use).Stent kinked & then fell apart.Needed to use a new stent, which was deployed successfully." additional information provided on 08may2018: "the midpart of the flexor sheath kinked, the physician could not deploy the stent inside the patient, the flexor sheath unraveled at the part of the kink (you will see this when the device is returned).".
Additional Manufacturer Narrative
Us clearance # k040505 k163169.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Problem statement as reported to customer relations: "while unsheathing catheter for stent deployment, outer catheter snapped, while inner portion of catheter remained intact (catheter & unsheathing mechanism both flushed with saline prior to use).Stent kinked & then fell apart.Needed to use a new stent, which was deployed successfully." additional information provided on 08may2018: "the midpart of the flexor sheath kinked, the physician could not deploy the stent inside the patient, the flexor sheath unraveled at the part of the kink (you will see this when the device is returned)." device evaluation the zib6-80-12.0-40 device involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.From customer testimony, it is known that the complaint device was advanced over a boston scientific amplatz wire guide.Resistance was not encountered during deployment.The patient¿s anatomy was not calcified or tortuous.Pre-dilation was conducted prior to stent deployment.The user confirmed that the handle was pulled towards the hub, and that the device was not pushed during deployment.The district manager confirmed that the target location was in the subclavian vein.The device related to this occurrence underwent a laboratory evaluation on the 31st may 2018.On evaluation of the returned device, it was observed that the outer flexor was separated, approximately 17cm from the connector cap.The stent was partially deployed, and 0.5cm was found to be exiting the flexor.The inner liner of the flexor was seen at the point of flexor separation.The red safety tab was not returned with the device.The stent was released in the lab, and was undamaged and 40mm in length.The device was flushed without issues, and a 0.035¿ diameter wire guide could pass through the device without resistance.The flexor length was 81cm, which was within specification of 80cm +1.3cm -0.8cm.There was no evidence of tactile damage on the other portions of the flexor.Complaint is confirmed as the failure was verified in the laboratory.It was found that the outer flexor was separated.Possible root causes for this occurrence could include the use of the device in a non-indicated location.From district manager's testimony, it is known that the complaint device was used in the subclavian vein.This could have created forces during deployment, that could have caused or contributed to the flexor separating.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.As per the product instructions for use: "the zilver 518 and 635 biliary stents are intended for palliation of malignant neoplasms in the biliary tree." document review prior to distribution all zilver biliary 635 devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.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.Summary complaint is confirmed as the failure was verified in the laboratory.It was found that the outer flexor was separated.The risk was determined to be no risk (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The procedure was completed with another stent.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER 635 BILIARY SELF-EXPANDING STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick
• MDR Report Key: 7559585
• Report Number: 3001845648-2018-00250
• Device Sequence Number: 2195184
• Product Code: FGE
• UDI-Device Identifier: 10827002362298
• UDI-Public: (01)10827002362298(17)201117(10)C1420876
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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
• Operator of Device: Health Professional
• Device Model Number: G36229
• Device Catalogue Number: ZIB6-80-12.0-40
• Device Lot Number: C1420876
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1