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

Model Number	G38488
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # p100022/s014.Investigation is still pending, a follow-up mdr report will be submitted to include the investigation conclusions.
Event or Problem Description
Per medwatch form: patient underwent diagnostic arteriogram and transcatheter intervention; first stent was deployed (pr 396544 lot c1741457), and md requested an additional stent.Prior to placement, it was discovered the date on the stent packaging was expired (b)(6)2022.(pr (b)(6) lot c1769805) date of implant: (b)(6)2022.Patient outcome: n/a - occurrence was discovered prior to patient contact.Sg (b)(6)2023.Patient/event info - notes: please provide the originator a list of any additional manufacturer questions required for investigation.Sg (b)(6)2023 the following information has been requested via email on (b)(6)2023.Sg (b)(6)2023 in the section ¿describe event¿ the statement ¿first stent was deployed, and md requested an additional stent.Prior to placement, it was discovered the date on the stent packaging was expired (b)(6)2022.¿ was g38489 ¿ lot c1741457 the 1st stent placed? if so was it removed due to the expiration date, or was it just a stent that you had on hand and not used? also please confirm that the second expired stent was not used on the patient?.
Additional Manufacturer Narrative
Pma/510(k) # p100022/s014.Supplemental report is being submitted as report is being cancelled as it longer meets reporting requirements - confirmation on 24-jul-2023 file can be cancelled since it is unconfirmed if the device was placed.
Event or Problem Description
Supplemental report is being submitted as report is being cancelled as it longer meets reporting requirements - confirmation on 24-jul-2023 file can be cancelled since it is unconfirmed if the device was placed.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 17049716
• Report Number: 3001845648-2023-00436
• Device Sequence Number: 15202004
• Product Code: NIU
• UDI-Device Identifier: 10827002384887
• UDI-Public: (01)10827002384887(17)220916(10)C1769805
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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: 09/16/2022
• Device Model Number: G38488
• Device Catalogue Number: ZISV6-35-125-7-80-PTX
• Device Lot Number: C1769805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2022
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male