MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number	TV-AB3480-J
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/01/2021
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.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device remains implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix stent graft system.Approximately three (3) years post initial procedure, routine follow-up identified a type ia endoleak and a type ii endoleak (non-device related).Additionally, there was patent left accessory renal noted coming in directly at the level of the sealing ring, a patent lumbar coming in just above the sealing ring, and a pair above the bifurcation of the aortic body of the device.The physician intends to perform reintervention; however, this has not yet been scheduled.The patient is reported to be stable.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the following events were confirmed: sac growth of 20.1mm, type ia endoleak and type ii endoleak of the left renal artery and lumbar arteries.This is consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of these events could not be determined with the lack of medical records and/or imaging available for review.Additionally, the clinical evaluation also shows that there is evidence to reasonably suggest a secondary endovascular procedure occurred on 08/26/2019 (coiling of a type ii endoleak lumbar) that was not included in the event as reported.The type ii endoleak likely contributed to the type ia endoleak, however the exact causation of the type ia endoleak is inconclusive.The final patient status was reported to be in stable condition.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Corrections: g3: date received by manufacturer - updated.H6: medical device problem codes: remove code 3190.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• Manufacturer (Section G): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; ,; santa rosa CA 95403
• Manufacturer Contact: gary kirchgater ; 3910 brickway blvd; ,; santa rosa, CA 95403 ; 8009832284
• MDR Report Key: 12788703
• Report Number: 3008011247-2021-00133
• Device Sequence Number: 19793369
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3210419FS022318041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: 04/19/2021
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS022318-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX ILIAC LIMB (LN FS030518-61).; OVATION IX ILIAC LIMB (LN FS030918-42).; OVATION PRIME FILL POLYMER (LN FF031618-02).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Unknown