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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Occlusion (1984); Perforation of Vessels (2135); Obstruction/Occlusion (2422)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative
Journal title: efficacy and safety of a mother-child technique for recanalization of chronic central venous occlusive disease in hem odialysis patients title: journal of vascular surgery: venous and lymphatic disorders year: 2020 ref: doi: 10. 1016/j. Jvsv. 2019. 10. 020. Journal reported death but there is no information to suggest the device caused or contributed to the death events. Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product. Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted detailing a study of the "efficacy and safety of a mother-child technique for recanalization of chronic central venous occlusive disease in hemodialysis patients" a total of 36 patients with symptomatic central venous disease and 45 patients with total venous occlusion were included in the study. The medtronic device admiral xtreme balloon was used in the procedures after recanalization and stents were implanted. Venous perforation, hematoma at puncture site and hemothorax were reported as procedural complications. Restenosis is reported to have occurred in 6 patients between 4 and 12 months follow up. All restenosis were treated with a second interventional angioplasty. 4 non-procedural related deaths were reported. 2 patients dies during follow up of acute heart failure at 2- 3 months after the procedure. 2 patients dies of gastro intestinal bleeding 1-2 months after the procedure.
 
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Brand NameADMIRAL XTREME
Type of DeviceCATHETER, 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 Key10640846
MDR Text Key210163437
Report Number9612164-2020-03793
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K062809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2021
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: 10/07/2020 Patient Sequence Number: 1
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