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	Death (1802); Failure of Implant (1924); Rupture (2208)
Date of Event	11/04/2020
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.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately 3 years post initial procedure, a degradation of the neck was identified following a computed tomography (ct) scan.Approximately 8 months after the computed tomography (ct) scan the patient presented with a rupture.The physician repaired the rupture utilizing 2 (non-endologix) gore proximal extensions.The patient was reported as doing well following the procedure but days after the procedure it was reported that the patient had passed away.It is uncertain what lead to the death of the patient.
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 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 the type 1a endoleak, rupture, secondary endovascular procedure and patient death were confirmed from the medical records.This is consistent with the reported adverse event/incident.Procedure related harms identified were hemodynamic instability, respiratory complications, and abnormal blood loss.The cause for the type 1a endoleak could not be determined with the medical records available for review.The rupture is related to the type 1a endoleak.The death was related to the patients significant comorbid conditions of ckd-end stage, copd, cad and hypertension.An additional 6 units of blood post operatively was needed; it was not clear from the medical records if the patient experienced further bleeding.Also the operative note clearly states the patient had no endoleak at the conclusion of the secondary endovascular procedure with multiple projections.The final patient status was reported as being expired on (b)(6) 2020.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: date of death, b5: describe event or problem, g4: date of 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 implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, a degradation of the neck was identified following a computed tomography (ct) scan.Approximately eight (8) months after the computed tomography (ct) scan the patient presented with a rupture.The physician repaired the rupture utilizing two (2) non-endologix gore proximal extensions.The patient was reported as doing well following the procedure.Days after the procedure it was reported that the patient had passed away.It is uncertain what lead to the death of the patient.Additional information: the clinical assessment identified a type ia endoleak.

• 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: 10924827
• Report Number: 3008011247-2020-00132
• Device Sequence Number: 14111269
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3191219FS07051626I
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 12/19/2019
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS070516-26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/27/2021
• 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: OVATION IX ILIAC LIMB FS042116-13; OVATION IX ILIAC LIMB FS051916-43; OVATION PRIME FILL POLYMER FF022217-01; OVATION IX ILIAC LIMB FS042116-13; OVATION IX ILIAC LIMB FS051916-43; OVATION PRIME FILL POLYMER FF022217-01
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR