MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; STENT, ILIAC VEIN

Model Number	G57449
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient of undisclosed gender and age underwent an undisclosed procedure in which the zilver vena venous self-expanding stent, g57449, was used.The stent was deployed in a tight lesion.When deployed the stent stretched to 200 cm from a 160cm length.When it deployed it went into the tissue tract of the patient.The patient was transferred from the facility to the hospital with an emergent procedure.As per clinical specialist at cook inc received 19-nov-21: the doctor did not observe the stent detach from the delivery catheter (rushing) and pulled the stent and stretched it.The patient had to go to the hospital for emergency removal of the stent.This file will capture the user error of an incorrect size access sheath used.A 9fr access sheath was used instead of a 7fr.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Common Device Name: STENT, ILIAC VEIN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 17268403
• Report Number: 3005580113-2023-00076
• Device Sequence Number: 5960119
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)231029(10)C1771926
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2023
• Report Date (Section F): 07/06/2023

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: 10/29/2023
• Device Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1771926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/08/2023
• Device Age: 30 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2023
• Date Device Manufactured: 10/29/2020
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/06/2023