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

Model Number	TV-AB3480-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Failure of Implant (1924)
Date of Event	08/03/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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 (aaa).An intraoperative type 1a endoloeak was identified during the initial procedure.The physician elected to concluded the procedure and monitored the patient.The physician will re-evaluate the type 1a endoleak at the patients 30- day follow up.
Event or Problem Description
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm (aaa).A type 1a endoloeak was identified post initial procedure.The physician elected not to treat the patient at the time.The patient will be monitored and a 30- day post op ct (computed tomography) will be performed to determine if the type 1a endoleak remains or has resolved.Patient in pending possible re-line.Additional information: this patient passed away which was not reported in the initial report.The death was discovered during a review of the discharge summary.
Additional Manufacturer Narrative
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 1a endoleak event / incident was confirmed.This is consistent with the reported adverse event / incident.The device, user, procedure, or anatomy relatedness of this event / incident could not be determined with the medical records available for review.The procedure-related harms identified were respiratory insufficiency, cardiopulmonary resuscitation (cpr) with arrest and death on the fourth postoperative day.The causation of the death could not be determined; while the patient had pre-existing severe respiratory disease as well as significant cardiac disease, which may have contributed to the death, this could not be confirmed with the information provided.The final patient status was reported as deceased.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: adverse event \ product problem.B4: adverse event \ product problem.B5: describe event or problem.G4: awareness date.H1: type of reportable event.H6: result code: remove code 3233.H6: conclusion code: 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
• MDR Report Key: 10474316
• Report Number: 3008011247-2020-00092
• Device Sequence Number: 16962474
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3230121FS01182047$
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

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: 01/21/2023
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS011820-47
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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 - FS022820-19.; OVATION IX ILIAC LIMB - FS051120-39.; OVATION PRIME FILL POLYMER - FF032520-02.
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 67 YR