MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	G43826
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.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
As reported to customer relations "the expired device was implanted in the right external iliac.The customer misread the expiration date on the packaging and did not realize that the device was expired until the procedure was completed.".
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.Device evaluation the ziv6-35-125-7-40 device of lot number c1247549 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.Lab evaluation ¿ n/a.Document review prior to distribution ziv6-35-125-7-40 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 ziv6-35-125-7-40 of lot number c1247549 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 c1247549.The instructions for use (ifu0043-9) instructs the user to ¿use the stent system prior to the expiration date specified on the package¿.Image review ¿ n/a.Root cause review a definitive root cause of user misreads the expiration date was identified from the available information.From the information provided, this event occurred on the (b)(6) 2019.The device had expired on the 12 july 2019.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
As reported to customer relations "the expired device was implanted in the right external iliac.The customer misread the expiration date on the packaging and did not realize that the device was expired until the procedure was completed.".

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8888136
• Report Number: 3001845648-2019-00406
• Device Sequence Number: 336068
• Product Code: NIU
• UDI-Device Identifier: 10827002438269
• UDI-Public: (01)10827002438269(17)190712(10)C1247549
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/13/2019

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: 07/12/2019
• Device Model Number: G43826
• Device Catalogue Number: ZIV6-35-125-7-40
• Device Lot Number: C1247549
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/16/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1