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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND 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 08/13/2019
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

During the index procedure a standard pta balloon catheter was used to treat the anterior tibial artery. Approximately 14 months later the patient was admitted for pain at the right foot and the angiography revealed stenosis of the ostial tibial artery and mild restenosis of the tibial artery treated with a balloon. Reported causality not related to the device, paclitaxel or procedure. Company causality possibly device related, not related to the procedure or paclitaxel. The patient recovered.

 
Manufacturer Narrative

Patient age, weight, year of birth provided. 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 IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key9437366
MDR Text Key170668632
Report Number9612164-2019-05060
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeIT
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 12/16/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2019
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 Received12/10/2019
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: 12/09/2019 Patient Sequence Number: 1
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