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

Model Number	TV-AB3480-E
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	03/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was originally implanted with an ovation main body and two (2) iliac limbs on (b)(6) 2015 by dr.(b)(6) at (b)(6) university med center.Dr.(b)(6) contacted endologix on (b)(6) 2018 to report that a type 1a endoleak per aortogram has developed for this patient whom is asymptomatic.The patient was discovered to have an expanding aneurysm, which was believed to be from a type 2 endoleak, both diagnosed by ct scan.The patient was treated for a type 2 on (b)(6) 2018 by having the sac packed with coils and onyx glue via a transcaval approach.When dr.Loh did a run to assess the effectiveness of the embolization by injecting dye into the sac thru the transcaval catheter, a jet of dye was seen traveling retrograde up the aorta past and above the sealing rings, demonstrating a type 1a endoleak.The physician theorizes the type 2 endoleak that he observed caused sac enlargement , which in turn caused the neck to dilate and create a type 1a.The patient is due back for a follow-up ct scan and pending the results may have further treatment.The patient is currently doing well.
Additional Manufacturer Narrative
Correction: (b)(4).Additional information: (b)(4).
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: type ia endoleak (observed intraoperative during transcaval procedure), multiple type ii endoleak, and sac growth.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.The procedure related harms identified were multiple type ii.The final patient status was reported to be doing well and on surveillance.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.Additional information: (b)(4).Correction: (b)(4).

• Brand Name: OVATION PRIME
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7504280
• Report Number: 3008011247-2018-00091
• Device Sequence Number: 16531548
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480E1
• UDI-Public: +M701TVAB3480E1/$$3180417FS031015482
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2018

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
• Operator of Device: Physician
• Device Expiration Date: 04/17/2018
• Device Model Number: TV-AB3480-E
• Device Catalogue Number: TV-AB3480-E
• Device Lot Number: FS031015-48
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018; 05/02/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/30/2018; 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX-ILIAC LIMB - LOT FS030515-37; OVATION IX-ILIAC LIMB - LOT FS042015-58
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR