MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Occlusion (1984); Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

Journal article title: the efficacy of paclitaxel drug-eluting balloon angioplasty versus standard balloon angioplasty in stenosis of native hemodialysis arteriovenous fistulas: an analysis of clinical success, primary patency and risk factors for recurrent dysfunction cardiovasc intervent radiol https://doi.Org/10.1007/s00270-019-02171-3 springer science+business media, llc, part of springer nature and the cardiovascular and interventional radiological society of europe (cirse) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

This article aims to investigate the efficacy of paclitaxel drug-eluting balloons (peb) versus standard balloon angioplasty (ba) in stenosis of native hemodialysis arteriovenous fistulas (avfs) and encompasses a total of 96 patients who underwent endovascular treatment with either peb or ba for a dysfunctional native avf before fistulography, the patients were examined using color doppler ultrasound.Digital angiographic images were obtained of the feeding artery, arteriovenous anastomosis, juxta-anastomotic segment of the efferent vein and draining veins up to the central veins.The stenosis was evaluated by comparing the stenotic and normal segments of the veins together with implementation of pta for the stenotic segments with a diameter of 50% of the normal segment.Pta was performed through the transvenous approach.Proximal access was achieved through the outflow vein with 7f vascular sheath insertion.Heparin was administered at a dose of 2500 iu, and an additional dose of 1250 iu was administered once every hour, if needed.The maximum dose was 5000 iu.Balloon size was determined according to the measured diameter of the reference vessel.According to the size of the veins, pebs and standard balloons with a diameter of 1 mm greater than the normal size of the venous segment (range 4¿7 mm) were used.In the ba group, standard balloons or high-pressure or non-compliant balloons in case of failure of procedure were used.In the peb group, over the-wire balloon was used.The balloon was inflated for 2 min, and the procedure was repeated if necessary.Hemostasis was achieved with manual compression.If stenosis was 30% after pta, the procedure was considered technically successful.Clinical success was defined as adequate dialysis after the procedure.All of avfs were already in use for dialysis, while insufficient fistula maturation was evident only in one patient with avf age of 1.5 months.The median age of avf was 18 months.Avf was left-sided in 58.3% of patients and radiocephalic in 56.3%.Clinical success was achieved in 97.9% of patients with minor complications in two (3.2%) patients.The median duration of follow-up was 292.5 days.Median duration of primary patency was 270 days overall, with primary patency rates of 45.8% at 6 months, 56.3% at 9 months and 6.3% at 12 months.Dysfunction recurrence was noted in 28.1% of patients (due to reocclusion in 25.1%) after median 180 days.

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8373132
• MDR Text Key: 137374056
• Report Number: 9612164-2019-00683
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K173515
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• 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
• Date Manufacturer Received: 02/20/2019
• 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
• Patient Age: 57 YR