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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR, INC) OVATION IX; MAIN BODY

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ENDOLOGIX (TRIVASCULAR, INC) OVATION IX; MAIN BODY Back to Search Results
Model Number TV-AB2380-I
Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problems Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924)
Event Date 04/24/2018
Event Type  Injury  
Manufacturer Narrative
The root cause for the emptying of the polymer syringe and intravascular leak of polymer could not be definitively confirmed with the information available.The most likely cause of the emptying of the polymer syringe and intravascular leak of polymer was likely due to a compromise in the integrity of the aortic body stent graft fill channels and/or mating junction of the delivery system to the stent graft; however, this could not be definitively confirmed.No procedure related harm detected.The delivery system was not available for evaluation and the stent graft remains implanted.As of the date of this report, there have been additional patient sequelae reported.A review of the device quality records showed that the device demonstrated compliance to established procedures and specifications at the time of manufacture.
 
Event Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The aortic body stent graft was positioned and deployed as expected.Upon polymer fill of the aortic body stent graft, the polymer syringe was observed to have emptied indicating a potential intravascular leak of polymer, and the patient experienced hypotension.The patient was treated for a hypersensitive reaction per the ifu and was stabilized.The final angiogram showed the presence of a type ia endoleak which was successfully resolved with the placement of a palmaz balloon expandable stent.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
 
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Brand Name
OVATION IX
Type of Device
MAIN BODY
Manufacturer (Section D)
ENDOLOGIX (TRIVASCULAR, INC)
3910 brickway blvd.
santa rosa CA 95403
Manufacturer (Section G)
ENDOLOGIX (TRIVASCULAR, INC)
3910 brickway blvd.
santa rosa CA 95403
Manufacturer Contact
victor arellano
2 musik
irvine, CA 92618
8009832284
MDR Report Key7541033
MDR Text Key109147449
Report Number3008011247-2018-00105
Device Sequence Number1
Product Code MIH
UDI-Device IdentifierM701TVAB2380I1
UDI-Public+M701TVAB2380I1/$$3200731FS062817020
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P120006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 04/24/2018
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? Yes
Device Operator Health Professional
Device Expiration Date07/31/2020
Device Model NumberTV-AB2380-I
Device Catalogue NumberTV-AB2380-I
Device Lot NumberFS062817-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/24/2018
Initial Date FDA Received05/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FILL POLYMER-FF012918-03; ILIAC LIMB - FS022118-45, FS022218-71
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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