MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 518 BILIARY SELF-EXPANDING STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G31439
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: k182980.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.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Upon trying to use stent, sheath disconnected from the deployment handle.The device was able to be deployed, but the sheath was held manually.The device was placed in proximal popliteal instead of distal popliteal/anterior tibial.
Additional Manufacturer Narrative
Pma/510(k)#: k182980.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).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Upon trying to use stent, sheath disconnected from the deployment handle.The device was able to be deployed, but the sheath was held manually.The device was placed in proximal popliteal instead of distal popliteal/anterior tibial.
Additional Manufacturer Narrative
Pma/510(k) #: k182980.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.Device evaluation: the zib5-125-4.0-40 device of lot number c1609477 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.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 15aug2019.Handle flexor separation was noted in the lab.Additionally the flexor was observed to be kinked approx.80 mm and 69mm from proximal flare, therefore following the laboratory evaluation additional information additional complaint file was requested to capture this failure separately.However, from information received ¿no kinks were noted on the stent flexor during procedure.Document review including ifu review: prior to distribution all zilver zib5 devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the relevant manufacturing records (c1609477) 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 lot number c1609477.It should be noted that as per the instructions for use, this device is ¿intended for palliation of malignant neoplasms in the biliary tree¿.There is evidence to suggest that the customer did not follow the instructions for use root cause review: 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 the use of the device in a location that is not indicated.From the information provided by the customer it is known that the device was intended for use in the ¿left femoral artery¿.It is also known that the patient¿s anatomy and the target location for the device were calcified and the physician felt resistance when advancing the wire guide and delivery system.It is possible that the use of the device in a calcified, non-indicated location may have caused and/or contributed to resistance during advancement and deployment.It is possible that this resulted in higher deployment forces on the outer sheath causing it to separate from the handle.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Upon trying to use stent, sheath disconnected from the deployment handle.The device was able to be deployed, but the sheath was held manually.The device was placed in proximal popliteal instead of distal popliteal/anterior tibial.

• Brand Name: ZILVER 518 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: 8802835
• Report Number: 3001845648-2019-00339
• Device Sequence Number: 342758
• Product Code: FGE
• UDI-Device Identifier: 10827002314396
• UDI-Public: (01)10827002314396(17)220502(10)C1609477
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2019

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: 05/02/2022
• Device Model Number: G31439
• Device Catalogue Number: ZIB5-125-4.0-40
• Device Lot Number: C1609477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/20/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019; 06/25/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/16/2019; 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1