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

Model Number	TV-AB3480-J
Medical Device Problem Codes	Device-Device Incompatibility (2919); Lack of Effect (4065)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/03/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in this event was explanted and will not be returned for evaluation as it was discarded.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Post polymer fill of the aortic body stent graft, the patient experienced hypotension and was successfully treated for an anaphylactic reaction per the device ifu.At the conclusion of the procedure the aneurysm was excluded.The patient will continue to be monitored.This event was previously reported under mdr # 300811247-2019-00166.Now, approximately four (4) years post implant the physician elected to explant the stent grafts.The physician stated the sealing rings were well opposed to the aortic wall.There was no type 1a or type 2 endoleak and no unorganized or fresh blood in the aneurysm sac; however, the common iliac arteries (cia) were aneurysmal and the patient had a gore (non-endologix) iliac branch endoprosthesis (ibe) placed on an unknown date for an unknown reason.The physician attributed the sac enlargement to sac wall deterioration.After this explant procedure, the patient was discharged out of the intensive care unit (icu) and is recovering.The explanted stent graft is not available for return.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.The device was not returned to endologix for evaluation because it was discarded.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 aneurysm enlargement of 10.7mm and explant are confirmed.This is consistent with the reported adverse event/incident.The clinical assessment determined that there was evidence to reasonably suggest a type 2 endoleak (likely lumbar), placement of a non endologix stent and coiling of the right internal iliac artery (date unknown) and patient death occurred that were not included in the event as reported.The type 2 endoleak and non endologix stent were discovered during review of the computed tomography report.Additionally, the death certificate dated (b)(6) 2023 was received.The patient death was determined to be procedure related.There was concomitant product use of non endologix stents (gore iliac branch endoprosthesis and coiling).It is unclear if this contributed to the reported event (off label).The operative note stated there was thrombus and the posterior wall of the sac was very friable and bleeding.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The procedure related harms were hemodynamic instability, cardiac arrest and death.The final patient status was reported as deceased in the operating room.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: b2: outcomes attributed to ae has been updated.B3: date of event has been updated.D6: explant date has been updated.G3: awareness date has been updated.H1: type of reportable event has been updated.H6: medical device problem codes: remove code 4065.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: 18276290
• Report Number: 3008011247-2023-00195
• Device Sequence Number: 6936898
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3220712FS062619013
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• 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): 11/06/2023

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: 07/12/2022
• Device Model Number: TV-AB3480-J
• Device Lot Number: FS062619-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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: GORE (NON-ENDOLOGIX) ILIAC BRANCH ENDOPROSTHESIS; OVATION IX ILIAC LIMB, LOT # FS012819-05; OVATION IX ILIAC LIMB, LOT # FS020519-21; OVATION PRIME FILL POLYMER, LOT # FF071919-02
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male