MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	G38483
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Complaint called in by (b)(6) on (b)(6) 2020 did (b)(6) 2020.As reported to customer relations: "device did not deploy.No other details provided." additional information provided by dm on 05mar2020: "how was the procedure completed? new ptx opened and used".
Event or Problem Description
Complaint called in by dm on 28feb2020--did 28feb2020.As reported to customer relations: "device did not deploy.No other details provided." additional information provided by dm on (b)(6) 2020: how was the procedure completed? new ptx opened and used".
Additional Manufacturer Narrative
Device evaluation: the zisv6-35-125-6-140-ptx device of lot number c1698997 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Document review: prior to distribution zisv6-35-125-6-140-ptx devices are subjected to a 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 manufacturing records for zisv6-35-125-6-140-ptx of lot number c1698997 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c1698997.It should be noted that the instructions for use (ifu0118-5) states the following: ¿do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.¿ there is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.It is possible that difficult patient anatomy may have caused and/or contributed to resistance during advancement and/or attempted deployment.It is possible that this resistance resulted in the inability to deploy the stent.However, as no additional information was received and as the device was not returned for evaluation, a conclusive root cause cannot be determined.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.A new zilver ptx device was opened and placed to complete the procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9883936
• Report Number: 3001845648-2020-00167
• Device Sequence Number: 2794652
• Product Code: NIU
• UDI-Device Identifier: 10827002384832
• UDI-Public: (01)10827002384832(17)211209(10)C1698997
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100022
• 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): 03/28/2020

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: 12/09/2021
• Device Model Number: G38483
• Device Catalogue Number: ZISV6-35-125-6-140-PTX
• Device Lot Number: C1698997
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1