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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
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.
 
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Brand NameADMIRAL XTREME
Type of DeviceCATHETER, 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 Key12727725
MDR Text Key279273822
Report Number9612164-2021-04147
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K173515
Number of Events Reported1
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 Received11/01/2021
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 Received01/27/2022
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
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