MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1418100-J
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Abdominal Pain (1685); Aneurysm (1708); Rupture (2208); Clinical Endoleak (4843)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the ovation ix stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately seven (7) years post initial procedure the patient presented at the emergency room with abdominal and back pain.The patient had been lost to follow up and was last seen in 2019.Currently the aaa measures 18cm and there is a contained rupture due to a right common iliac artery (cia) type 1b endoleak.The physicians elected to perform a secondary intervention procedure and placed a 16x27x140 gore excluder (non-endologix) limb which successfully resolved this event.It was noted that the patient received one unit of blood and was taken to the intensive care unit (icu) post operatively.The next day the patient was transferred to the telemetry floor and was discharged one day later.
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.Device remains implanted.
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 1b endoleak of the right common iliac artery, aneurysm enlargement of 105mm, rupture and additional endovascular procedure (non endologix limb) are confirmed.This is consistent with the reported adverse event/incident.The clinical assessment also shows there was evidence to reasonably suggest coiling of the internal mesenteric artery occurred (date unknown) occurred that was not included in the event as reported.The coiling was discovered during a review of the ct scan dated 05/08/2023.There was probable cranial migration of the right limb of 14.9mm, however that could not be conclusively determined without comparative imaging.Device, user, procedure of anatomy relatedness of this complaint could not be determined.No procedure related harms for this complaint were identified - (renal disease and chronic anemia were chronic medical conditions).The final patient status was reported as discharged home on postoperative day seven.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: describe event or problem has been updated awareness date has been updated.Investigation finding codes: remove code 3233.Investigation conclusion codes: remove code 11.
Event or Problem Description
The patient was implanted with the ovation ix stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately seven (7) years post initial procedure the patient presented at the emergency room with abdominal and back pain.The patient had been lost to follow up and was last seen in 2019.Currently the aaa measures 18cm and there is a contained rupture due to a right common iliac artery (cia) type 1b endoleak.The physicians elected to perform a secondary intervention procedure and placed a 16x27x140 gore excluder (non-endologix) limb which successfully resolved this event.It was noted that the patient received one unit of blood and was taken to the intensive care unit (icu) post operatively.The next day the patient was transferred to the telemetry floor and was discharged one day later.Additional information: an internal clinical assessment determined that there was evidence to reasonably suggest coiling of the internal mesenteric artery occurred (date unknown) occurred that was not included in the event as reported.The coiling was discovered during a review of the computed tomography (ct) scan dated 05/08/2023.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• 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: 17020506
• Report Number: 3008011247-2023-00066
• Device Sequence Number: 6286476
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1418100J1
• UDI-Public: +M701TVIL1418100J1/$$3190112FS08121549Q
• 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: 2016
• 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): 05/09/2023

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: 01/31/2019
• Device Model Number: TV-IL1418100-J
• Device Catalogue Number: TV-IL1418100-J
• Device Lot Number: FS081215-49
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2016
• 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 ILIAC LIMB, LOT # FS060115-22; OVATION IX MAIN BODY, LOT # FS120215-15; OVATION PRIME FILL POLYMER, LOT # FF121415-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Unknown