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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  malfunction  

Manufacturer Narrative

Pma # p050017/s006.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

(b)(6) called in stating he received a call from account (b)(6) on (b)(6) 2022.The account relayed that a bilateral stent placement in the common iliac was performed, but the incorrect devices were picked from stock by mistake and placed in the patient.The account called to request the potential risks.(b)(6) reached out to product management and provided the customer the potential risks (vessel deterioration, pseudoaneurysm due to higher radial force, and back pain due to higher radial force).The procedure went as planned and the patient has had no reported adverse events.No additional or interventional procedures have been performed or are planned at this time due to the occurrence.

Manufacturer Narrative

Cancellation mdr being submitted due to completion of investigation and conclusions finding that file no longer being reportable based on off-label use.

Event Description

Cancellation mdr being submitted due to completion of investigation and conclusions finding that file no longer reportable based on off-label use.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 13512770
• MDR Text Key: 296308049
• Report Number: 3001845648-2022-00081
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/13/2022
• Event Location: Hospital
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1