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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-AB2680-J
Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Patient Problems Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Myocardial Infarction (1969); Rash (2033)
Event Date 05/25/2018
Event Type  Injury  
Manufacturer Narrative
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.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 and anaphylactic shock, and the skin appeared red and flush.The patient was treated for a hypersensitive reaction per the ifu and was stabilized.It was also noted that the patient developed a hematoma from the proglide placed in the left groin.The aneurysm was successfully excluded at the conclusion of the implant procedure.Two days post-op, the patient experienced a myocardial infarction, and was stabilized and discharged (b)(6) 2018.A cardiac bypass is planned at a later date.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
 
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.An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made on (b)(6) 2018 and denied.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.Based on similar reported events, 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.The delivery system was not available for evaluation and the stent graft remains implanted.As of the date of this report, there have been no 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.A field safety notice (fs-0009) was released on (b)(6) 2018 to communicate the risk of polymer leak events with the ovation device under circumstances in which the device is not used in accordance with the device instructions for use.
 
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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
MDR Report Key7636442
MDR Text Key112276865
Report Number3008011247-2018-00147
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
PMA/PMN Number
P120006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Notification
Type of Report Initial,Followup
Report Date 05/25/2018
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 Date04/16/2021
Device Model NumberTV-AB2680-J
Device Catalogue NumberTV-AB2680-J
Device Lot NumberFS040918-27
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/25/2018
Initial Date FDA Received06/25/2018
Supplement Dates Manufacturer Received05/25/2018
Supplement Dates FDA Received09/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FILL POLYMER-FF011518-01; ILIAC LIMB-FS121117-77, FS030518-67
Patient Outcome(s) Required Intervention;
Patient Age77 YR
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