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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 Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 10/06/2020
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article was submitted detailing a non-sponsored randomised trial of patient¿s with dysfunctional dialysis access at a single centre. 40 patients evenly split into 2 groups (dcb and poba) were included in the study. Medtronic¿s in. Pact admiral (dcb) and admiral xtreme pta (poba) balloons were used. Technical success was achieved in 90% of cases. Clinical successs was achieved in 100% of patient¿s in the dcb group and 95% of patient¿s in the poba group. One patient in the poba group developed acute thrombosis 1 week after intervention with open thrombectomy performed. Primary patency rate was 90% in the dcb group at six months compared to 55% in the poba group. Secondary patency rate was 95% in dcb group at six months compared to 80% in poba group. Primary patency rate attwelve months was 65% in dcb group compared to 30% in poba group and secondary patency at twelve months was 95% in dcb group compared to 65% in poba group.

 
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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 
EI  
091708734
MDR Report Key11044667
MDR Text Key222613298
Report Number9612164-2020-04992
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberK173515
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 12/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2020
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
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: 12/21/2020 Patient Sequence Number: 1
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