MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; EXTENDER

Model Number	TV-EX282845-J
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an ovation ix extender to treat an abdominal aortic aneurysm (off -label procedure due to the use of afx with ovation devices).Approximately 4 months post initial procedure, a type 1a endoleak was identified during a routine follow up.Reportedly, the patient has covid and there is no schedule date for re-intervention yet.
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 type 1a endoleak is confirmed.The clinical evaluation also shows reasonable evidence to suggest the type 1a endoleak was present at initial implant and persisted.This finding was discovered during an examination of the operative note dated (b)(6) 2022 and discharge summary dated (b)(6) 2022.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest the following occurred that were not included in the event as reported: pre-existing type ii endoleaks (anatomy-related) of the lumbar and internal mesenteric arteries, and intraoperative inability to advance sheath for delivery of a proximal extension, estimated blood loss of 1300cc and access site complication in the right femoral artery.These findings were discovered during an examination of the 2-month post index ct (computed tomography) scan, and the operative note with discharge summary, respectively.The most likely causation for the reported event is user-related due to concomitant product use of an ovation ix extender with an afx2 bifurcated stent graft (off-label condition).Procedure-related harms for this event could not be determined.The final patient status was not reported.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: a2 age at time of event b3 date of event b5 describe event or problem d10 therapy dates h6 investigation finding codes; remove 3233 h6 investigation conclusion codes; remove 11.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an ovation ix extender to treat an abdominal aortic aneurysm (off-label procedure due to use of afx with ovation devices).Approximately 4 months post initial procedure, a type 1a endoleak was identified during a routine follow up.Reportedly, the patient has covid and there is no schedule date for re-intervention yet.Additional information received per clinical assessment indicating that multiple type ii endoleaks (non-device-related) occurred prior to implant with the afx2 and ovation ix products.In addition, it was noted per clinical that the type 1a endoleak was present at initial implant and persisted.The physician plans to re-intervene and surgery has been scheduled.It was also discovered per clinical assessment that during the initial implant procedure, the physician was unable to advance the afx introducer system in preparation for implant of an afx proximal extension.During this procedure, there was abnormal blood loss (1300cc) to the patient as well as an access site complication in the right femoral artery.A separate report was filed per intraoperative event of unable to advance afx introducer system with abnormal blood loss and access site complication (reference mfr.Report # 2031527-2022-00230).
Additional Manufacturer Narrative
Corrections: b6: relevant tests and lab data has been updated.G3: date received by manufacturer has been updated.

• Brand Name: OVATION IX
• Common Device Name: EXTENDER
• 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: 15070781
• Report Number: 3008011247-2022-00082
• Device Sequence Number: 12106758
• Product Code: MIH
• UDI-Device Identifier: 00850007370077
• UDI-Public: (01)00850007370077(17)240611(10)FS06102112
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 07/01/2022

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: 06/11/2024
• Device Model Number: TV-EX282845-J
• Device Lot Number: FS061021-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 09/07/2022; 11/03/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/16/2022; 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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: AFX2 BIFURCATED STENT GRAFT LOT 2437906-005; AFX2 BIFURCATED STENT GRAFT, SN (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female