MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT

Model Number	G57445
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: nio stent, iliac.(b)(4).
Event or Problem Description
According to the physician, "the scaffolding is too far apart, the clot came back into the stent.User was having another stent (wall stent) brought in to be used".The stent was being placed via the common femoral vein.Further information provided states, "when the stent began it¿s deployment the system jumped back almost as if the wire was no stiff enough, on the second stent we used a lunderquist wire which stabilized the system a bit more".The delivery system held straight and still during deployment, however the physician commented that the pinning the metal cannula/hub at the back end seemed wobbly.Furthermore, the stent jumped distal early in the deployment and was pulled back gently to proper location.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11030141
• Report Number: 3005580113-2020-00462
• Device Sequence Number: 19159404
• Product Code: QAN
• UDI-Device Identifier: 10827002574455
• UDI-Public: (01)10827002574455(17)231013(10)C1767668
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2020
• Report Date (Section F): 12/15/2020

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: 10/13/2023
• Device Model Number: G57445
• Device Catalogue Number: ZVT7-35-80-14-100
• Device Lot Number: C1767668
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2020
• 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: 54 YR