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

Model Number	TV-AB2980-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	06/09/2021
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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent system.Approximately three (3) years post initial procedure, the patient presented at routine follow-up with an endoleak (at indeterminate origin) per ct (computed tomography) scan.In addition, a patent ima (inferior mesenteric artery) is filling the aneurysm sac (classified as a type ii endoleak with aneurysm enlargement (unknown diameter)).It is unknown if the physician plans to re-intervene.Patient is reportedly in good condition.
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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.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 type 2 endoleak of the internal mesenteric artery is confirmed.The type 2 endoleak of the internal mesenteric artery is anatomy related.The sac growth is unconfirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type 1a endoleak and type 2 endoleak of the lumbar artery.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.The final patient status was reported to be in good 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: b5: describe event or problem has been updated.G4: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent system.Approximately three (3) years post initial procedure, the patient presented at routine follow-up with an endoleak (at indeterminate origin) per ct (computed tomography) scan.In addition, a patent ima (inferior mesenteric artery) is filling the aneurysm sac (classified as a type ii endoleak with aneurysm enlargement (unknown diameter)).It is unknown if the physician plans to re-intervene.Patient is reportedly in good condition.Additional information: an internal clinical assessment determined that there was evidence to reasonably suggest a type 1a endoleak and type 2 endoleak (non-device-related) of the lumbar artery.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 12408661
• Report Number: 3008011247-2021-00103
• Device Sequence Number: 4191748
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3210508FS050318528
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 05/08/2021
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS050318-52
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/22/2021
• 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: FILL POLYMER, SN (B)(6); OVATION IX ILIAC LIMB, SN (B)(6); OVATION IX ILIAC LIMB, SN (B)(6)
• Outcome Attributed to Adverse Event: Other