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 No Information (3190)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

Common device name: niu stent, superficial femoral artery, drug-eluting.

Event Description

Kibrik 2019 ¿a real-world experience of drug eluting and non-drug eluting stents in lower extremity peripheral arterial disease¿ a retrospective review was performed on all in patient infrainguinal lower extremity endovascular procedures between (b)(6) 2014 and (b)(6) 2016, which involved stent implantation.Procedures involving the common femoral artery, superficial femoral artery, and above knee popliteal artery were included.Procedures involving iliac, below knee popliteal, tibial, peroneal, and pedal arteries were excluded.The type of stent, number of stents, length of each stent, and location of stent were recorded for each procedure.Data on each patients trans-atlantic inter society consensus ii class were collected.End-points included stent thrombosis, restenosis, re-intervention, and limb loss.Post-operative arterial duplexes were obtained every three months to determine stent patency during follow-up visits.In-stent stenosis was defined as >60% narrowing on arterial duplex.Thrombosis was defined as in-stent occlusion, and limb loss involved only major amputations in the treated extremity.Bivariate analysis and students two-sample t-test were used to analyze the data.Ibm-spss ¿ 22 was used for all analyses.This file was opened to capture re-intervention - 14.3% for des.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11035903
• MDR Text Key: 222336603
• Report Number: 3005580113-2020-00466
• 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: Physician
• Type of Report: Initial
• Report Date: 12/17/2020,12/18/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR