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

Model Number	TV-AB3480-J
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Thrombosis/Thrombus (4440)
Date of Event	09/29/2021
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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix stent graft system.Approximately two and a half (2.5) years post initial procedure, routine follow-up identified a right hypogastric artery aneurysm.The physician intends to perform reintervention; however, this has not yet been scheduled.The patient is reported to be stable.
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.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 bilateral iliac limb stenosis is confirmed.The sac growth complaint is unconfirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type ia endoleak occurred that was not included in the event as reported.These findings were discovered during an examination of the 28month post implant ct scan.The most likely causation for the bilateral iliac limb stenosis and type ia endoleak is most likely anatomy related.The aorta was extremely angulated, both proximal and distal.The distal angulation likely contributed to the bilateral iliac stenosis.Procedure related harms for this adverse event/incident could not be determined.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.The neck was off label with juxtarenal angle of 119 degrees (should be equal to or less than 60).The neck was also conical at 37%.These findings likely contributed to the type ia endoleak.The final patient status was reported as doing well post-secondary intervention.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.B1: outcomes attributed to ae - updated.B5: describe event or problem ¿ updated.G3: awareness date ¿ updated.H6: health effect - impact code ¿ remove 4614.H6: medical device problem codes ¿ remove 3191.H6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix stent graft system.Approximately two and a half (2.5) years post initial procedure, routine follow-up identified a right hypogastric artery aneurysm.The physician intends to perform reintervention; however, this has not yet been scheduled.The patient is reported to be stable.Subsequent to the initial report, additional information was provided reporting that reintervention was completed by extending the left common iliac due to potential limb thrombosis with a 22x120 ovation ix iliac limb and covered the right hypogastric aneurysm and extended with a 10x160 ovation ix iliac limb.Reportedly, the patient did well and both limbs are patent.Additionally, clinical assessment determined that there was evidence to reasonably suggest a type ia endoleak occurred that was not included in the event as reported.The type ia endoleak was discovered during review of the 28-month post implant ct scan.

• 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: 12917509
• Report Number: 3008011247-2021-00138
• Device Sequence Number: 17540033
• Product Code: MIH
• UDI-Device Identifier: M701TVAB3480J1
• UDI-Public: +M701TVAB3480J1/$$3210926FS092218219
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 11/18/2021

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: 09/26/2021
• Device Model Number: TV-AB3480-J
• Device Catalogue Number: TV-AB3480-J
• Device Lot Number: FS092218-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2018
• 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 (LN FS083018-55); OVATION IX ILIAC LIMB (LN FS103018-39); OVATION PRIME FILL POLYMER (LN FF010818-04)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female