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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
Catalog Number UNK-CV-GWY-SBI
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Occlusion (1984)
Event Date 04/11/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
During a revascularization ,of the left target lesion,an in. Pact admiral balloon catheters was used to treat the left target lesion. During a second revascularisation procedure the target lesion was treated with an admiral xtreme pta balloon catheter. During a third revascularisation of the left target lesion a femoral to polipiteal stent graph was used. Approximately 12 months post the first revascularisation, 19 months post the second revascularisation, and 8 months post the femoral to polipiteal stent graph, the patient suffered an occlusion of the left femorol-polipiteal bypass graft. The event was treated with embolectomy and medication. The investigator assessed that the event was not related to index device, procedure or paclitaxel. The event is resolved. Update received 01-mar-2018: the event was also treated with medication.
 
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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 Key7361025
MDR Text Key103137444
Report Number9612164-2018-00544
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeKS
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
Report Date 03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-CV-GWY-SBI
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 Received02/27/2018
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: 03/22/2018 Patient Sequence Number: 1
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