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

Model Number	G38486
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2020
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
Expired zilver ptx placed in patient.No issues during the procedure.No adverse effects reported.No additional interventions needed.The physician put the patients on antibiotics after the case because he was worried about the sterility of the stent.Patient had no issues at time of/immediately after procedure.Facility will not be reporting to the fda.
Event or Problem Description
Expired zilver ptx placed in patient.No issues during the procedure.No adverse effects reported.No additional interventions needed.The physician put the patients on antibiotics after the case because he was worried about the sterility of the stent.Patient had no issues at time of/immediately after procedure.Facility will not be reporting to the fda.
Additional Manufacturer Narrative
This file was initially reported based on the potential risk of off label use, however off label use is defined as not using the device for its intended purpose or against the indication for use which in this case has not occurred.Following below investigation conclusions it has been determined that placement of an expired device is user error which is low risk and has driven re-assessment to non reportable.This report is therefore being submitted as a cancellation report.Device evaluation: the zisv6-35-125-7-40-ptx device of lot number c1489304 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 zisv6-35-125-7-40-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 zisv6-35-125-7-40-ptx of lot number c1489304 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 c1489304.It should be noted that the instructions for use (ifu0118-5) states the following: ¿do not use stent after the ¿use by¿ date specified on the package.¿ there is evidence to suggest that the user did not follow the ifu.Root cause review: a definitive root cause of the user misreading the use by date or not checking the use by date of the device prior to implantation was identified from the available information.From the available information it is known that the device expired on 19 january 2020 and the date of the event was 27 january 2020.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the physician prescribed a course of antibiotics to the patient as a precaution.However, it is also known from the information provided that 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.

• 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: 9755900
• Report Number: 3001845648-2020-00128
• Device Sequence Number: 16716541
• Product Code: NIU
• UDI-Device Identifier: 10827002384863
• UDI-Public: (01)10827002384863(17)200119(10)C1489304
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/16/2020

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: 01/19/2020
• Device Model Number: G38486
• Device Catalogue Number: ZISV6-35-125-7-40-PTX
• Device Lot Number: C1489304
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1