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

Model Number	G38480
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations via phone conversation "the physician's staff called the dm notifying her that an expired ptx was deployed in a patient.The device had been expired for two days.Note: the facility did not realize the device was expired until the physician was ready to deploy the device.The staff conveyed this information tot the physician; however the physician decided to go ahead and deploy the device.
Additional Manufacturer Narrative
Device evaluation the zisv6-35-125-6-80-ptx device of lot number c1622112 involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution zisv6-35-125-6-80-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 zisv6-35-125-6-80-ptx of lot number c1622112 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 c1622112.It should be noted that the instructions for use (ifu0118-6) states the following: ¿¿do not use the stent after the use by date specified on the package.¿¿ there is evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause of user error was identified from the available information.From the description it is known that the device had expired two days prior to use.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.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental report being submitted due to the investigation being completed on 12-apr-2021.

• 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: 11307833
• Report Number: 3001845648-2021-00082
• Device Sequence Number: 1283917
• Product Code: NIU
• UDI-Device Identifier: 10827002384801
• UDI-Public: (01)10827002384801(17)210107(10)C1622112
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 01/07/2021
• Device Model Number: G38480
• Device Catalogue Number: ZISV6-35-125-6-80-PTX
• Device Lot Number: C1622112
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2021
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1