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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIVASCULAR, INC. OVATION IX ABDOMINAL STENT GRAFT SYSTEM; ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
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TRIVASCULAR, INC. OVATION IX ABDOMINAL STENT GRAFT SYSTEM; ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM Back to Search Results
Model Number TV-AB2080-J
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Bacterial Infection (1735)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device not released for evaluation.
 
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient presented approximately 2 months post-operative with evidence of a potential infection.The patient underwent a surgical conversion and the stent graft was explanted.As of the date of this report, there have been no additional patient sequelae reported.
 
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Brand Name
OVATION IX ABDOMINAL STENT GRAFT SYSTEM
Common Device Name
ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM
Manufacturer (Section D)
TRIVASCULAR, INC.
3910 brickway blvd.
santa rosa CA 95403
MDR Report Key5915654
Report Number3008011247-2016-00097
Device Sequence Number19501
Product Code MIH
UDI-Device IdentifierM701TVAB2080J1
UDI-Public+M701TVAB2080J1/$$3190425FS030116090
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P120006
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Expiration Date03/01/2018
Device Model NumberTV-AB2080-J
Device Catalogue NumberTV-AB2080-J
Device Lot NumberFS030116-09
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/27/2016
Initial Report FDA Received Date08/30/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age52 YR
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