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

Catalog Number UNKNOWN

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

Patient Problems Restenosis (4576); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Main eligibility criteria: hospital stay associated with the index procedure, with one of the following: patients with = 1 bms, without any des and without any covered metal stent (cms).Patients with = 1 cook des (zilver ptx).Female or male age = 18 years old on day of hospital admission for the hereafter related index procedure.Admitted in a (b)(6) hospital, public or private, between (b)(6) 2011 and (b)(6) 2019.Based on the high level data presented in this report, 1 complaint for 1 patient quantity is being opened conservatively to capture outcome n°5: hospitalization for new lower-limb artery procedure.Require intervention/additional procedures s=4.

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 zilver freeze study and was opened conservatively to capture restenosis and outcome n°5: hospitalization for new lower-limb artery procedure for one patient.Manufacturing records review prior to distribution all zilver ptx devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Instructions for use and label instructions for use (ifu0117) which accompanies the device states the following: potential adverse events that may occur include the following: ¿ restenosis of the stented artery 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 analysis a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patients pre existing conditions/characteristics.From the study it is known that the patients included, had baseline characteristics which included coronary artery disease, peripheral artery disease and diabetes mellitus.These are all known predictors of restenosis.There is no evidence within the study to suggest any device malfunction or deterioration in device characteristics.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.Confirmation of complaint complaint is confirmed based on customer testimony and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation the complaint was raised from the zilver freeze study and was opened conservatively to capture outcome n°5: hospitalization for new lower-limb artery procedure for one patient.Confirmed quantity of 01 patient, confirmed used.According to the medical input, the patients would have required intervention/additional procedures due to this occurrence.Investigation findings conclude a possible root cause could be attributed to the patients pre existing conditions/characteristics.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 29-feb-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; national technology park; 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: 18020368
• MDR Text Key: 326797886
• Report Number: 3001845648-2023-00808
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 07/04/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female