MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZIV6-35-125-5.0-100-PTX-CI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Restenosis (4576)

Event Date 04/11/2019

Event Type  Injury  

Event Description

The date of procedure was (b)(6) 2015 and study leg was the right leg.The adverse event involved the study limb, which was specifically manifested as involving the study vessels and the patient had clinical symptoms.The investigators assessed the category of this event as vascular occlusion or restenosis.Because it was atherosclerosis that led to stent stenosis, the investigator thought the event was related to the study device and study procedure.The patient's treatment physician performed surgical treatment (vascular repair)and intravascular percutaneous treatment(bare stent) on the patient.As of (b)(6) 2023, the patient is still alive.

Manufacturer Narrative

Pma/510(k) # p100022/s001.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to the completion of the investigation on (b)(6) 2023.

Manufacturer Narrative

Pma/510(k) # p100022/s027.Device evaluation the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.This file was created from the attached post market study complaint form manufacturing records review prior to distribution all zilver ptx devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review as per cirl procedure historical data review is not required for complaint category "adverse event" instructions for use and label it should be noted that the instructions for use (ifu0063) lists occlusion and restenosis of the stented artery as potential adverse events.There is no evidence to suggest the user did not follow the ifu or label.Image review an image was not returned for evaluation.Root cause analysis a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patient condition of atherosclerosis.It is possible that this atherosclerosis led to the stent restenosis.As previously noted, restenosis of a stented artery and occlusion are listed as known potential adverse events within the ifu and are common adverse events of endovascular procedures that can be caused by obstruction to the vessel confirmation of complaint complaint is confirmed based on customer testimony and/or rep testimony.Summary of investigation the complaint was raised via an retrospective data collection post market study.According to the initial reporter, the date of procedure was (b)(6) 2015 and study leg was the right leg.The adverse event involved the study limb, which was specifically manifested as involving the study vessel, and the patient had clinical symptoms.The investigators assessed the category of this event as vascular occlusion or restenosis.Because it was atherosclerosis that led to stent stenosis, the investigator thought the event was related to the study device and study procedure.Confirmed quantity of 02 devices, confirmed used.According to the initial reporter, the patient's treatment physician performed surgical treatment (vascular repair)and intravascular percutaneous treatment(bare stent) on the patient.As of (b)(6) 2023, the patient is still alive.Investigation findings conclude a possible root cause of the patient condition of atherosclerosis.As previously noted, restenosis of a stented artery and occlusion are listed as known potential adverse events within the ifu and are common adverse events of endovascular procedures that can be caused by obstruction to the vessel.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• 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: 17142714
• MDR Text Key: 317308852
• Report Number: 3001845648-2023-00470
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 00827002350656
• UDI-Public: (01)00827002350656(17)151209(10)C1095559
• Combination Product (y/n): Y
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2015
• Device Catalogue Number: ZIV6-35-125-5.0-100-PTX-CI
• Device Lot Number: C1095559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2019
• Event Location: Hospital
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• 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
• Patient Outcome(s): Required Intervention