MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

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

Patient Problems Rupture (2208); Restenosis (4576)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Journal title: drug eluting stent vs.Drug coated balloon for native femoropopliteal artery disease: a two centre experience 1078-5884/2020 european society for vascular surgery.Published by elsevier b.V.All rights reserved.Https://doi.Org/10.1016/j.Ejvs.2020.10.008.If information is provided in the future, a supplemental report will be issued.

Event Description

Objective: there have been limited clinical trials comparing drug eluting stents (dess) and drug coated balloons (dcbs) in the treatment of femoropopliteal artery disease.This two centre retrospective and prospective cohort study sought to compare des with dcb for the treatment of native femoropopliteal artery disease.Methods: a total of 288 limbs (242 patients) with native femoropopliteal artery disease were treated with dess (zilver ptx; 102 limbs) or dcbs (in.Pact admiral; 186 limbs) in two korean endovascular centres between 19 january 2013 and 5 may 2018 and followed for a median duration of 19.6 months.The primary endpoint was primary clinical patency.Propensity score matching (psm, 162 limbs) and inverse probability weighted (ipw) adjustment were performed to adjust for confounding baseline characteristics.Results: the dcb group had fewer lesions with trans-atlantic inter-society consensus (tasc) ii type c/d (55.9% vs.70.6%, p ¼.021) or total occlusions (43.5% vs.77.5%, p <(><<)>.001) and showed shorter lesion lengths (164.2 105.4 mm vs.194.8 86.8 mm, p ¼.009) than the des group.After psm, baseline clinical and lesion characteristics of the two groups were comparable except for larger reference vessel diameter in the des group (5.4 0.6 vs.5.1 0.7, p ¼.025).Adjunctive atherectomy was performed in 32.1% of the dcb group and in 2.5% of the des group (p <(><<)>.001).The provisional stenting was required in 14.8% of the dcb group.At two year follow up, the dcb group showed higher primary clinical patency (74.6% vs.56.7%, hazard ratio [hr] 0.51, 95% confidence interval [ci] 0.27e0.96, p ¼.032) and freedom from target lesion revascularisation (85.9% vs.71.3%, hr 0.39, 95% ci 0.17e0.89, p ¼.021) than the des group.Survival from all cause death did not differ between groups (87.6% vs.92.1%, hr 1.85, 95% ci 0.62e5.52, p ¼.26).Conclusion: in this two centre cohort, dcbs with selective use of adjunctive atherectomy achieved more favourable outcomes than dess for native femoropopliteal artery disease.In the dcb group, four patients experienced vascular rupture which was successfully managed endovascularly: two patients were treated with viabahn covered stents (gore, flagstaff, az, usa), and two other patients with supera stents (abbott vascular, santa clara, ca, usa).In the des group, there was one case of vascular access site bleeding which did not require an invasive procedure.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11595685
• MDR Text Key: 260799943
• Report Number: 9612164-2021-01267
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 03/31/2021
• 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: 70 YR