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 Problem Obstruction/Occlusion (2422)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Bianchini et al 2023 - real world outcomes of cook zilver ptx in femoro popliteal district: multicenter experience.Background: the purpose is to evaluate the follow-up outcomes after femoro-popliteal stenting with cook zilver ptx in a multicenter experience.Methods: collected data from four units were retrospectively joined and analyzed considering zilver ptx deployed from august 2009 according to the instruction for use.Patient demographics, preoperative comorbidities, rutherford classification, arterial characteristics and stent data were considered.Target lesion revascularization (tlr) was defined as reintervention performed for =50% diameter stenosis after recurrent clinical symptoms.Primary outcome was the freedom from tlr (fftlr) and its risk factors.Secondary outcomes were primary patency (pp) of the stent, amputation-free survival (afs) and their risk factors.Results: considering 203 patients (mean age: 73.5 years ±10.6; male: 66.5%) and 263 stents (median 2 stents/patient, range 1-5stent/patient), chronic limb-threatening ischemia (clti) affected 154 patients (75.9%).The length of the treated lesion was <120 mm in 99 (48.8%), =120 mm and <200 mm in 65 (32%) and =200 mm in 39 (19.2%) cases, respectively; the reference vessel mean diameter was 5.5±0.7 mm; chronic total occlusion was treated in 153 (75.4%) patients, the popliteal artery was involved in 56 (27.6%) cases and prior endovascular intervention was performed in 27 (13.3%) cases.Two or more crural run-off vessels were patent in 124 (61.1%).Mean follow-up was 23.2 months ±21.3.At 1, 2 and 3 years, the fftlr was 90.6±4.2%, 86.4±6.1% and 80.4±8.3%, respectively, and the pp was 85.6±5.0%, 74.2±7.6% and 72.7±8.2%, respectively.Negative prognostic factor for fftlr and pp was the reference vessel diameter (p=0.001 and p<0.001, respectively).At 1, 2 and 3 years, the afs was 81.8±6.0%, 75.5±7.1% and 74.2±7.5% respectively; coronary artery disease (p=0.041) and clti (p=0.011) resulted negative prognostic factors.Conclusions: in the real-world practice, around 3/4 of patients were treated for clti.The rate of fftlr is high, and pp is substantially lower.A small vessel diameter (<5 mm) is a negative factor for both fftlr and pp.The rate of afs is about 75% at 2 years and clti and coronary artery disease are negative prognostic factors.This file will capture 19.6% of 263 stents with a loss of patency treated by tlr.Require intervention/additional procedures s=4.N = 203 (mean age: 73.5years±10.6; male: 66.5%) and 263 stents (median 2 stents/patient).(p% x x = y) 19.6% x 263 = 51.548 ~ 52 stents with a loss of patency treated by tlr.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18261244
• MDR Text Key: 329672983
• Report Number: 3001845648-2023-00872
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• 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?: No
• Distributor Facility Aware Date: 02/01/2023
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 73 YR
• Patient Sex: Male