MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

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

Patient Problems Stenosis (2263); Restenosis (4576)

Event Type  Injury  

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

Stern, 2020, zilver ptx and paclitaxel exposure and long-term mortality of patients treated with the zilver ptx drug-eluting stent.From an institutional database, we retrospectively identified all patients treated with the zilver ptx stent between 2013 and 2015.This represents the initial two-year period following approval by the fda.Demographic and comorbidity information was collected at baseline.Procedural and device information were recorded at the time of procedure, including number of stents placed and lesion length.The initial exposure dose of paclitaxel was calculated using the manufacturer¿s information on amount of drug per device.For the primary outcome of overall mortality, patients or their families were personally contacted by telephone to determine if they are currently alive or dead.Secondary outcomes evaluated included patency with and without reintervention.When paclitaxel coated devices (including both additional stents and drug-coated balloons) were used in reintervention, this was added to determine an individual¿s total lifetime paclitaxel exposure dose.Sixty-four patients were treated with zilver ptx during the study period.This includes 15 patients who underwent staged, bilateral interventions, for a total of 79 limbs treated.One of the major advantages of our study, however, is that we were able to account for subsequent reinterventions using paclitaxel and factor this into the lifetime exposure dose.These are real patients who presented back with restenosis or occlusion and were often treated with dcbs.This complaint is conservatively capturing 15 cases of restenosis as the paper does not specify how many patients required intervention for this.

Manufacturer Narrative

Pma/510(k) #: p100022/s001.The unknown device of unknown 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.As the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl it should be noted that restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0117-5).There is no evidence to suggest the user did not follow the ifu.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.From the literature article it is known that patient pre-existing conditions included hypertension, hyperlipidaemia, diabetes, smoking, coronary artery disease (cad), renal insufficiency, atrial fibrillation, and rutherford classifications between 2 and 5.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.Summary complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Final mdr being submitted due to the completion of the investigation on 23-sept-21.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10870719
• MDR Text Key: 218908997
• Report Number: 3001845648-2020-00877
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention