MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION PRIME; MAIN BODY

Model Number	TV-AB2980-E
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Bacterial Infection (1735); Death (1802); Renal Failure (2041); Sepsis (2067); Respiratory Failure (2484)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An ovation prime abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.The patient returned approximately 3 years post index procedure with an infected graft, and the physician decided to explant the graft.The explant procedure went as expected, however, complications from the surgery led to patient expiration one day post intervention.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the infection was found to be unknown/undetermined due to the lack of relevant medical information surrounding the event.Associated clinical harms for this event included: infection, respiratory failure, renal failure, and surgical conversion.Procedure related harms included: ischemia, embolism, hypotension, additional surgical procedure, and death.The final patient disposition was expired following the additional surgical procedure due to cardiac arrest.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.Codes: (b)(4).

• Brand Name: OVATION PRIME
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 7070822
• Report Number: 3008011247-2017-00098
• Device Sequence Number: 1450072
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980E1
• UDI-Public: +M701TVAB2980E1/$$3171009FS073014040
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

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: Health Professional
• Device Expiration Date: 10/09/2017
• Device Model Number: TV-AB2980-E
• Device Catalogue Number: TV-AB2980-E
• Device Lot Number: FS073014-04
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR