MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT

Catalog Number UNKNOWN

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

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Procode: niu stent, superficial femoral artery, drug-eluting.

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.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10945228
• MDR Text Key: 219498558
• Report Number: 3005580113-2020-00454
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2020
• Distributor Facility Aware Date: 11/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention