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

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

Patient Problems Vascular Dissection (3160); Restenosis (4576)

Event Date 02/15/2021

Event Type  Injury  

Manufacturer Narrative

Average age, majority gender, event date: date of article publication long-term safety and efficacy of angioplasty of femoropopliteal artery disease with drug-coated balloons from the acoart i trial journal of vascular surgery (2021) 74(3);p756-762. E3 doi. Org/10. 1016/j. Jvs. 2021. 01. 041 if information is provided in the future, a supplemental report will be issued.

Event Description

The acoart i trial was a prospective, multicenter, randomized controlled trial designed to investigate the efficacy and safety of dcbs in the treatment of femoropopliteal artery lesions. A total of 200 chinese patients with femoropopliteal artery disease were randomized to treatment with a drug-coated balloon (dcb) or uncoated balloon (ucb). The patients in the dcb group were treated with a non-medtronic paclitaxel-coated peripheral balloon catheter. The patients in the control group were treated with an admiral xtreme peripheral balloon catheter. Pre-dilation of the lesion with uncoated balloon catheters was not mandatory but was recommended for both groups. The clinical endpoints at the 5-year follow-up evaluation included all-cause mortality, cd-tlr, and major amputation of the treated leg. The use of post dilatation and provisional fpa stenting was left to the discretion of the operators in the case of an unsatisfactory primary result or the presence of flow-limiting dissection. Of the 200 initially enrolled patients, 180 completed the 5-year follow-up evaluation. Of the 180 patients who had completed the 5-year follow-up evaluation, 91 were in the ucb group. No significant differences were present between the dcb and ucb groups in the baseline patient and lesion characteristics. All the provisional stents deployed during the trial had been self-expanding bare metal stents, with no drug-eluting stents deployed. Provisional fpa stenting was performed in 21% of ucb group. Major amputation of the treated leg was required for 4 of 91 patients in the ucb group. During the 5-year follow-up period, 24 of the 91 patients in the ucb group had died, for a mortality rate of 26. 4% for the ucb group. Of the 20 patients who had been lost to follow-up, 1 in the ucb group had undergone cd-tlr before they were lost to follow-up. These patients were included in the total cd-tlr follow-up data. Thus, for the entire study period, cd-tlr had been performed in 40 of 92 patients in the ucb group. At 5 years after intervention, the freedom from cd-tlr rate was 59. 1% in the ucb group.

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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 ; EI ; 091708734
• MDR Report Key: 12727725
• MDR Text Key: 279273822
• Report Number: 9612164-2021-04147
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/01/2021 Patient Sequence Number: 1