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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVATEC SPA ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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INVATEC SPA ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Occlusion (1984)
Event Date 10/01/2016
Event Type  Injury  
Manufacturer Narrative
Additional information received reported that the event is resolved. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The investigator assessed this event as not related to the index device, procedure or paclitaxel. Cec adjudicated that event is related to study device, but not related to procedure or paclitaxel. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Approximately 15 months post index procedure, the patient underwent a target vessel revascularization of the left popliteal. Two admiral xtreme and two in. Pact admiral balloons were used as treatment. Approximately 21. 5 months post the revascularization of the left popliteal, the patient suffered occlusion. Patient was treated with pta, stenting and ballooning. Event is unresolved.
 
Manufacturer Narrative
Patient suffered restenosis and reocclusion on (b)(6) 2016 and not (b)(6) as previously reported. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. 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)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer (Section G)
INVATEC SPA
via martiri della liberta, 7
roncadelle 25030
IT 25030
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6342739
MDR Text Key109695116
Report Number3004066202-2017-00023
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSI
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,Followup,Followup,Followup
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2017
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 Received02/05/2018
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: 02/20/2017 Patient Sequence Number: 1
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