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

Model Number	G57445
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: nio stent, iliac.Product code: qan.
Event or Problem Description
As initially reported to customer relations: a female patient of undisclosed age underwent a bilateral venous stenting procedure in which the zilver vena venous self-expanding stent, g57445, was used.The right side deployed as intended.The left side after deployment the stent did not fully expand.The physician attempted to balloon the stent but it still looked deformed.The physician then realigned with a wall stent and alignment looked better.Physician noted the left side had a hard lesion.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 12031807
• Report Number: 3005580113-2021-00073
• Device Sequence Number: 4752456
• Product Code: QAN
• UDI-Device Identifier: 10827002574455
• UDI-Public: (01)10827002574455(17)231008(10)C1766386
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2023
• Device Model Number: G57445
• Device Catalogue Number: ZVT7-35-80-14-100
• Device Lot Number: C1766386
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• 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