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.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: Physician
• 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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Race: Asian