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

Lot Number UNKNOWN

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

Patient Problem Death (1802)

Event Date 06/20/2016

Event Type  Death  

Manufacturer Narrative

Event date is literature article published date acotec drug-coated balloon catheter: randomized, multicenter, controlled clinical study in femoropopliteal arteries: evidence from the acoart i trial jacc: cardiovascular interventions (2016) volume:9, issue:18, 1941-1949 https://doi.Org/10.1016/j.Jcin.2016.06.0.If information is provided in the future, a supplemental report will be issued.

Event Description

This study was conducted to investigate the efficacy and safety of a new paclitaxel-coated balloon catheter in the treatment of stenotic or occluded femoropopliteal arteries.Two hundred patients with peripheral arterial occlusive disease were prospectively randomized to treatment with new paclitaxel-coated or standard uncoated balloon catheters.The primary endpoint was angiographic late lumen loss at 6 months, measured by a blinded core laboratory.Secondary angiographic endpoints (6 months) and specific clinical endpoints (1 year) were binary restenosis, ankle-brachial index, rutherford stage, clinically driven target lesion revascularization (tlr), and amputation.Patients¿ mean age was 66 years, 74% were men, 31% were smokers, and 55% had diabetes.Patients were treated with admiral xtreme peripheral balloon catheter.During the period between treatment and 6-month follow-up, 2 patients in each treatment group (uncoated balloon and dcb) died of disease; 1 patient in the dcb group died shortly after the 6-month angiographic control, but the death was reported at 6 months.Two patients in the control group were excluded because of treatment with nonassigned balloon, and 1 patient in the dcb group was lost to follow-up after 6 months.A total of 39.6% patients treated with uncoated balloon underwent target lesion revascularization.It was concluded that the use of paclitaxel-coated balloon catheters markedly improved angiographic and clinical outcomes of interventions despite advanced disease in the majority of patients.

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #10; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #10; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7039992
• MDR Text Key: 92276744
• Report Number: 9612164-2017-01624
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• 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): Death
• Patient Age: 66 YR