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	Unspecified Infection (1930); Vascular Dissection (3160)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it was explanted and discarded.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 was discarded.
Event or Problem Description
The patient was being implanted with the ovation ix stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that the graft required to be explanted due to an impending rupture.It was noted that the rupture was due to weakening and tearing of the aortic wall caused by infection.The graft was successfully explanted and the patient is doing well.The explanted devices are not available for return/evaluation.
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 explanted and was not returned to endologix for evaluation.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 aortic rupture, aortic infection and surgical explant complaints are confirmed.This is consistent with the reported adverse event/incident.However, it was reported that upon device explant, it was noted that the rupture was due to weakening and tearing of the aortic wall caused by infection.The patient developed severe abdominal pain, only after on (b)(6) 2022 intervention for a type 2 endoleak (lumbar).The patient could have developed the aortic infection at this time, however that could not be conclusively determined.The clinical evaluation also shows reasonable evidence to suggest an additional procedure with embolization of lumbar vessels for a type 2 endoleak with sac growth (amount unknown) occurred on (b)(6) 2022 that was not included in the event as reported.The additional procedure was discovered during review of the fifty-three-month post implant ct scan and review of operative noted dated on (b)(6) 2022.Device, user, procedure or anatomy relatedness of this complaint could not be determined.The procedure related harms identified were abnormal blood loss (3000ml requiring 7 units of blood) and hemodynamic instability (intubated on vasopressors to icu).The final patient status was reported to be discharged to an inpatient rehabilitation program on postoperative day fifteen.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.G3: date received by manufacturer has been updated.H6: investigation finding: remove code 3233.H6: investigation conclusion: remove code 11.
Event or Problem Description
The patient was being implanted with the ovation ix stent graft system to treat an abdominal aortic aneurysm (aaa).It was reported that the graft required to be explanted due to an impending rupture.It was noted that the rupture was due to weakening and tearing of the aortic wall caused by infection.The graft was successfully explanted and the patient is doing well.The explanted devices are not available for return/evaluation.Additional information: an internal clinical assessment determined that there was evidence to reasonably suggest an additional procedure with embolization of lumbar vessels for a type 2 endoleak with sac growth (amount unknown) occurred on (b)(6) 2022 that was not included in the event as reported.The additional procedure was discovered on (b)(6) 2022 during review of the fifty-three-month post implant ct scan and review of operative noted dated on (b)(6) 2022.

• 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: 15556511
• Report Number: 3008011247-2022-00124
• Device Sequence Number: 17890171
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3210111FS12201709$
• 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: 2018
• Device Explanted Year: 2022
• 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): 09/15/2022

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: 01/11/2021
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS122017-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2018
• 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 ILIAC LIMB, LOT # FS110617-41.; OVATION IX ILIAC LIMB, LOT # FS120717-17.; OVATION PRIME FILL POLYMER, LOT # FF020718-01.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown