MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT

Model Number	G38482
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Reaction to Medicinal Component of Device (4574)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name) niu stent, superficial femoral artery, drug-eluting.
Event or Problem Description
According to the initial reporter, post a leg angiogram with paclitaxel stent placement procedure, the initial reporter stated that the patient came back in with indurated skin lesions.They wonder if the paclitaxel might be responsible for this.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 15589425
• Report Number: 3005580113-2022-00109
• Device Sequence Number: 7374735
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)240401(10)C1943829
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2022
• Report Date (Section F): 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Device Lot Number: C1943829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/16/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2022
• Date Device Manufactured: 05/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Female