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

Model Number	G57449
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product code/common name: qan.
Event or Problem Description
According to the initial reporter: a (b)(6) male patient underwent a revascularization of a femoral venous lesion in which the zilver vena venous self-expanding stent, g57449, was used.The physician deployed the stent, then saw via fluoroscopy that 2-3cm lengthwise in the middle portion of the stent was twisted.Attempt to dilate with a 14mm balloon.The balloon got caught on the stent and popped and was stuck on stent.Approximately after ninety minutes of trying the physician was able to get the balloon out.Physician then deployed a 14mm cordis stent inside of the zilver stent and post dilated but was able to only dilate stent lumen open to 8mm of the intended 14mm.The patient did well and physician determined this was enough flow through the stent to satisfactory and will continue to monitor for the next several months.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 14159404
• Report Number: 3005580113-2022-00047
• Device Sequence Number: 5932195
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)241216(10)C1897053
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2022
• Report Date (Section F): 04/15/2022

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: 12/16/2024
• Device Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1897053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2022
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2022
• Date Device Manufactured: 12/16/2021
• 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; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male