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

Model Number	G38488
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Niu stent, superficial femoral artery, drug-eluting.
Event or Problem Description
According to the initial reporter: "device bunched up in the center during deployment.User was able to fully deploy it and didn't notice issue until after deployment.They were able to balloon it to re-expand it (in diameter), but may have to bring patient back to check it and possibly extend it as it is still shortened (looks like about a 60 instead of an 80).Long occlusion of the sfa.Pictures available.".

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 12091596
• Report Number: 3005580113-2021-00082
• Device Sequence Number: 4187311
• Product Code: NIQ
• UDI-Device Identifier: 10827002384887
• UDI-Public: (01)10827002384887(17)230209(10)C1815683
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2021
• Report Date (Section F): 06/30/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2023
• Device Model Number: G38488
• Device Catalogue Number: ZISV6-35-125-7-80-PTX
• Device Lot Number: C1815683
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/09/2021
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Date Report Sent to FDA: 06/30/2021