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

Model Number	TV-AB2980-J
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	12/23/2021
Type of Reportable Event	Serious Injury
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 seven (7) months post initial procedure, the patient presented with an endoleak (at indeterminate origin).The physician elected to treat the patient by implanting two (2) ovation ix extenders and a palmaz stent on (b)(6) 2019.The seal was reportedly improved and the patient was discharged in stable condition.Reference mfr.Report # 3008011247-2019-00047 for this previously reported event.Approximately two (2) years post-secondary procedure, the patient presented at routine follow-up with a type 1b endoleak (on right-side), type ii endoleak (non-device-related), and a persistent type 1a endoleak (previously treated with a palmaz stent).The physician elected to treat the patient by implanting two (2) ovation ix iliac limbs on (b)(6) 2021.Reference mfr.Report # 3008011247-2021-00043.Approximately eight (8) months post third procedure, the patient presented with an aneurysm enlargement, a type 1a, and 1b endoleak.The physician plans to re-intervene and the patient is reportedly in stable condition.
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.
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 could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident was received by endologix.The user facility was unable to provide this information.Due to the absence of medical records and medical imaging; device, use, procedure, and/or anatomy relatedness to this adverse event/incident could not be evaluated.The final patient status was report as 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: b5: describe event or problem has been updated.H6: investigation finding: remove code 3233.H6: investigation conclusion: 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 seven (7) months post initial procedure, the patient presented with an endoleak (at indeterminate origin).The physician elected to treat the patient by implanting two (2) ovation ix extenders and a palmaz stent on (b)(6) 2019.The seal was reportedly improved and the patient was discharged in stable condition.Reference mfr.Report # 3008011247-2019-00047 for this previously reported event.Approximately two (2) years post-secondary procedure, the patient presented at routine follow-up with a type 1b endoleak (on right-side), type ii endoleak (non-device-related), and a persistent type 1a endoleak (previously treated with a palmaz stent).The physician elected to treat the patient by implanting two (2) ovation ix iliac limbs on (b)(6) 2021.Reference mfr.Report # 3008011247-2021-00043.Approximately eight (8) months post third procedure, the patient presented with an aneurysm enlargement, a type 1a, and 1b endoleak.The physician plans to re-intervene and the patient is reportedly in stable condition.Additional information: no further intervention was performed as the patient is still waiting on cardiac clearance.

• 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: 13155278
• Report Number: 3008011247-2021-00148
• Device Sequence Number: 17180366
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3210125FS010918121
• 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
• 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): 12/23/2021

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: 01/25/2021
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS010918-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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 EXTENDER FS092618-37; OVATION IX EXTENDER FS112918-30; OVATION IX ILIAC LIMB FS041916-72; OVATION IX ILIAC LIMB FS050217-34; OVATION IX ILIAC LIMB FS062920-17; OVATION IX ILIAC LIMB FS072517-35; OVATION IX ILIAC LIMB FS080320-12; OVATION PRIME FILL POLYMER FF011518-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male