MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN

Catalog Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Common name: niu stent, superficial femoral artery, drug-eluting.Product code: niu.This event has been reported by the manufacturer under mdr 3001845648-2019-00554.

Event Description

As initially reported to customer relations per literature article emailed from cook ireland: introduction: previous studies have reported the clinical outcomes of the zilver ptxtm, a paclitaxel-eluting nitinol stent (cook medical, bloomington, in, usa), in patients with de novo or restenotic lesions of the femoropopliteal artery.Intravascular optical coherence tomography (oct) provides imaging of blood vessels with resolutions at the 10 mm scale.Using this imaging modality, we were able to precisely measure the underlying vascular response at 12-month follow-up after the use of zilver ptx drug-eluting stent in femoropopliteal lesions.Methods: twenty patients with superficial femoral artery (sfa) disease (total occlusions or significant stenosis) were prospectively enrolled in a single-arm study.All patients were treated with balloon angioplasty and implantation of zilver ptxtm des in the sfa followed by imaging with oct.Thirteen patients completed 12- month follow-up to date and reimaging with oct.Variables evaluated included neointimal growth and malapposed struts at 1-mm intervals, peri-strut low-intensity area (plia) at 10-mm intervals, and neovessels throughout.The latter two are markers of inflammation.Results: compared to baseline, the mean percentage of malapposed struts was significantly less at follow up (11.1% vs.0.3%, p(i/4)0.0001).At follow-up, the mean plia per visible strut was 0.018 mm2 (sd 0.019 mm2), the mean length-normalized neointimal volume was 7.8 mm2 (sd 3.8 mm2), the mean percentage of luminal narrowing was 35% (sd 18%), the mean of the maximum percentage of restenosis was 60% (sd 25%), and the mean number of vessels per mm of stent was 0.125 (sd 0.159).Conclusion: these findings show the current state of disease at 12 months after zilver ptx implantation and suggest persistent inflammation and delayed vascular healing.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9244093
• MDR Text Key: 168610380
• Report Number: 3005580113-2019-00573
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• 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?: Yes
• Date Report Sent to FDA: 10/16/2019
• Distributor Facility Aware Date: 10/09/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2019
• 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