MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; Stent, superficial femoral artery, drug-eluting

Model Number G38483

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Reaction to Medicinal Component of Device (4574)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

Common device name) niu stent, superficial femoral artery, drug-eluting.

Event 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.

Manufacturer Narrative

Section c has been updated.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: Stent, superficial femoral artery, drug-eluting
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 15581324
• MDR Text Key: 301509450
• Report Number: 3005580113-2022-00107
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384832
• UDI-Public: (01)10827002384832(17)240505(10)C1957452
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2024
• Device Model Number: G38483
• Device Catalogue Number: ZISV6-35-125-6-140-PTX
• Device Lot Number: C1957452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2022
• Distributor Facility Aware Date: 09/16/2022
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2022
• Date Device Manufactured: 07/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female