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

Model Number	G57447
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common name/product code: foreign: (b)(6).
Event or Problem Description
According to the initial reporter: a male patient of unspecified age underwent an iliac vein stenting procedure in which the zilver vena venous self-expanding stent, g57447, was used.Prior to stent placement the physician used an (another manufacturer's) medical device and was able to pull out a lot of the clot.The physician deployed the stent in the iliac and when went to do an ultrasound it was noted the stent had pushed up or traveled up to the ivc.A wire was used to go up through and hook onto the stent and the physician was then able to pull the stent back down to the external iliac.A (another manufacturer's) wall stent was then deployed inside of the zilver.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 14167227
• Report Number: 3005580113-2022-00048
• Device Sequence Number: 5011829
• Product Code: QAN
• UDI-Device Identifier: 10827002574479
• UDI-Public: (01)10827002574479(17)240906(10)C1864908
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/21/2022
• 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: 09/06/2024
• Device Model Number: G57447
• Device Catalogue Number: ZVT7-35-80-16-60
• Device Lot Number: C1864908
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2022
• Date Device Manufactured: 09/06/2021
• 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
• Patient Sex: Male