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 Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Per journal article hoyt et al 2019 (zilver ptx) ¿ ¿assessment of vascular patency and inflammation with intravascular optical coherence tomography in patients with superficial femoral artery disease treated with zilver ptx stents.¿ we used a 6f sheath and the contralateral retrograde access ap-proach after obtaining initial access using either an 18-gauge needle or a 21-gauge micro-puncture needle.The distal tip of the 6f sheath was placed in the common femoral artery (cfa) for imaging of the sfa.The target lesion was identified.Following peripheral angiography, patients with significant sfa disease (n60%) or total occlusions (100%) were treated with balloon angioplasty and stenting using the zilver ptx stent.Balloon sizing was based on 1:1 vessel ratio with the length covering from minimally diseased distal segment to minimally diseased proximal segment.After pre-dilatation, appropriate stent deployment was performed.Stent diameter was based on the manufacturer's guide-lines for vessel sizing (i.E., 1 to 2 mm stent: vessel oversizing).Stent length was based on covering the significant lesion completely from minimally diseased distal segment to minimally diseased proximal segment.An angiogram was performed to verify full deployment and expansion of the device; if there was incomplete expansion within the stent at any point along the lesion, post-deployment balloon dilatation was performed.Oct was performed to evaluate stent expansion and stent apposition as well as determination of intraluminal clot.Contralateral femoral arterial approach was used in 12 patients and ipsilateral retrograde popliteal artery approach was used in 1 patient.Two of the 13 patients required reintervention at follow-up after oct imaging due to angiographic narrowing of the vessels.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10919061
• MDR Text Key: 219003235
• Report Number: 3005580113-2020-00448
• 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: 11/20/2020,11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR