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

Model Number	G57448
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Nio stent, iliac.Product code: qan.
Event or Problem Description
Complaint received from dm via e-mail on 25may2021--did 28may2021.As reported to customer relations: "a physician was performing a venous intervention and had an issue with the deployment of our zilver vena stent.As he was trying to deploy the stent, the silver handle seemed to have friction and/or got caught on something within the deployment catheter as he was trying to pin/pull.This caused the stent to jump further toward the ivc than the physician would have liked.When he removed the stent from the patient and placed it on the table, he was still able to replicate the issue and the handle was getting caught on something when pushing it in and out of the system.(b)(4).Lot- c1770415.Access site- left common femoral vein.Deployment site- left common iliac vein.Due to this deployment issue, physician felt it was necessary to place another kissing iliac stent on the right side.They will not be reporting to fda.".

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 12033894
• Report Number: 3005580113-2021-00075
• Device Sequence Number: 3782253
• Product Code: QAN
• UDI-Device Identifier: 10827002574486
• UDI-Public: (01)10827002574486(17)231021(10)C1770415
• Combination Product (Y/N): N
• 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): 06/21/2021
• Report Date (Section F): 06/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: G57448
• Device Catalogue Number: ZVT7-35-80-16-100
• Device Lot Number: C1770415
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2021
• 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