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

Catalog Number ZIV6-35-125-6.0-100-PTX-CI

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

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

P100022/s001 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The date of procedure was (b)(6) 2014 and study leg was the left leg.The adverse event involved the study limb, which was specifically manifested as involving the study vessels,the study lesion and the patient had clinical symptoms.The investigators assessed the category of this event as occlusion/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 intravascular percutaneous treatment(drug-eluting balloon) on the patient.The patient recovered and was discharged on (b)(6), 2016 as of (b)(6), 2023, the patient is still alive.

Manufacturer Narrative

Pma/510(k) # p100022/s001.This file was created from pmcf study to capture occlusion/restenosis.Device evaluation: the ziv6-35-125-6.0-100-ptx-ci device of c1010207 lot number involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution all zilver ptx drug-eluting peripheral stent devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records forziv6-35-125-6.0-100-ptx-ci of lot number c1010207 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: n/a.Instructions for use/label: it should be noted that restenosis of the stented artery and occlusion are listed as a known potential adverse events within the instructions for use (ifu0063).There is no evidence to suggest the user did not follow the instructions for use.Image review an image was not returned for evaluation.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing/underlying conditions.Restenosis of the stented artery is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.Occlusion is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by obstruction to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary: according to the initial reporter, the patient experienced occlusion/restenosis.Confirmed quantity of 2 devices, confirmed used.Patient outcome, as per information provided 'the patient's treatment physician performed intravascular percutaneous treatment(drug-eluting balloon)on the patient.The patient recovered and was discharged on (b)(6) 2016.As of (b)(6) 2023, the patient is still alive.' investigation findings conclude that a possible root cause could be attributed to patient pre-existing/underlying conditions.Restenosis of the stented artery and occlusion are listed as a known potential adverse events within the instructions for use.Complaint is confirmed based on customer and/or rep testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 30-jan-2024.

• 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: 17457297
• MDR Text Key: 320375321
• Report Number: 3001845648-2023-00593
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2015
• Device Catalogue Number: ZIV6-35-125-6.0-100-PTX-CI
• Device Lot Number: C1010207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2016
• Event Location: Hospital
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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