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

Model Number	TV-AB3480-J
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Renal Failure (2041); Clinical Endoleak (4843)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
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.H3 other text : devices remain implanted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the ovation ix abdominal aortic aneurysm stent system.Approximately five and a half (5.5) years post initial procedure, the patient presented emergently with a type ia endoleak.The physician elected to treat the patient by implanting a palmaz (non-endologix) stent and utilizing a true (non-endologix) balloon on (b)(6) 2023.The endoleak was successfully resolved.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of the ovation ix abdominal aortic aneurysm stent system.Approximately five and a half (5.5) years post initial procedure, the patient presented emergently with a type ia endoleak.The physician elected to treat the patient by implanting a palmaz (non-endologix) stent and utilizing a true (non-endologix) balloon on (b)(6) 2023.The endoleak was successfully resolved.Additional information: internal clinical assessment identified that significant aneurysm enlargement was noted per operative report and ct (computed tomography) scan at four (4) days post secondary intervention with a recurring type ia endoleak (related to inadequate treatment with the palmaz (non-endologix) stent and ballooning on (b)(6) 2023).The physician elected to further treat the patient by implanting a non-endologix fenestrated graft on (b)(6) 2023; this tertiary intervention resulted in occlusion of the right renal artery, which then caused acute kidney injury (aki).The patient was readmitted on (b)(6) 2023 for treatment of congestive heart failure (chf) related to the acute kidney failure which stemmed from the (b)(6) 2023 procedure.
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 the reported ovation ix, type ia endoleak and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest aneurysm enlargement (of 37mm) occurred that was not in the event as reported.In addition, the type ia endoleak recurred on (b)(6) 2023 and an additional endovascular procedure was completed on (b)(6) 2023; the re-intervention caused an occluded right renal artery during the fenestrated (non-endologix) graft placement which then resulted in an acute kidney injury and hospitalization from (b)(6) 2023 to (b)(6) 2023.These findings were discovered during an examination of ct scan dated (b)(6) 203 and operative notes dated (b)(6) 2023.It was also noted that the palmaz (non-endologix) stent placed on (b)(6) 2023 covered the right renal artery, which caused difficulty during cannulation.No clear type ia endoleak was identified on (b)(6) 2023 (one day post secondary intervention).In addition, the patient was readmitted on (b)(6) 2023 for treatment of chf related to the aki, which the patient developed from the procedure done on (b)(6) 2023; patient was taken off diuretics at discharge due to the aki.No procedure-related harms were identified.Device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.The final patient status was reported as discharged home in stable condition on postoperative day one.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 g3 awareness date.H6 investigation finding codes; remove 3233.H6 investigation conclusion codes; remove 11.

• 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: 17416125
• Report Number: 3008011247-2023-00147
• Device Sequence Number: 8902101
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3201005FS091617163
• 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: 2017
• 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): 07/11/2023

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: 10/05/2020
• Device Model Number: TV-AB3480-J
• Device Lot Number: FS091617-16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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, LN FS032117-60.; OVATION IX ILIAC LIMB, LN FS062216-18.; OVATION PRIME FILL POLYMER, LN FF102317-02.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male