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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 Problem Stenosis (2263)
Event Date 03/23/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During the index procedure one medtronic standard pta balloon was used to treat the venous outflow of the right arm. Approximately 9 months post index procedure the patient suffered shunt stenosis. This was treated with medication and a non medtronic pta to treat the anastomosis. The event is resolved. The investigator and safety reported that the event is not related to the index device, procedure or paclitaxel. Cec adjudicated event is not related to procedure or therapy but related to device. The revascularization procedure was adjudicated as a clinically driven target lesion revasc.
 
Manufacturer Narrative
Patient medical history is hypertension, hyperlipidemia, diabetes, renal insufficiency coronary heart disease and previous peripheral revascularization of the anastomosis. If information is provided in the future, a supplemental report will be issued.
 
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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 Key8109721
MDR Text Key128559392
Report Number9612164-2018-03379
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K173515
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 01/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
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 Received12/09/2018
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: 11/28/2018 Patient Sequence Number: 1
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