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

Model Number	TV-EX282845-J
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Clinical Endoleak (4843)
Date of Event	10/05/2022
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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx vela suprarenal extension and (2) ovation ix extenders (off-label).Approximately 6 years post initial procedure, patient has been identified with a 1b endoleak and is pending re-intervention.
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 ib endoleak is unconfirmed.This is not consistent with the reported adverse event/incident.The initial procedure was outside the indications of use (off-label) due to concomitant devices (ovation ix iliac extensions with afx); this could have contributed to the reported event.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 to be pending reintervention.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: h6 investigation finding codes; remove 3233; h6 investigation conclusion codes; remove 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx vela suprarenal extension and (2) ovation ix extenders (off-label).Approximately 6 years post initial procedure, patient has been identified with a 1b endoleak and is pending re-intervention.Additional information: the physician elected to treat the patient by implanting one (1) afx vela infrarenal, one (1) afx limb stent graft and one (1) additional ovation ix extender on (b)(6) 2023.The reline was reportedly successful, and the patient is in stable condition.Additional information; clinical assessment identified that a type 3b endoleak (of the bifurcated stent graft) with significant aneurysm enlargement (of the left iliac artery) also occurred.
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 1b endoleak (of the left common iliac artery) and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest a type 3b endoleak (of the distal bifurcated stent graft) and aneurysm sac growth (of the left iliac artery) measuring 11.7mm occurred that was not included in the event as reported.These findings were discovered during an examination of the ct (computed tomography) scan dated on (b)(6) 2022.The most likely causation for the reported event is user-related.The initial procedure was outside the indications of use (off-label) due to concomitant devices (ovation ix iliac extensions with afx); this likely contributed to the type 1b endoleak.In addition, the reported left iliac diameter was 2.58cmx2.68cm (ifu requirement should be 10mm-23mm); this also likely contributed to the type 1b endoleak.It is unclear if the ovation ix extenders in the bilateral iliacs contributed to the type 3b endoleak.No procedure-related harms were identified.The final patient status was reported as discharged home 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.

• 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: 15673250
• Report Number: 3008011247-2022-00135
• Device Sequence Number: 15045915
• Product Code: MIH
• UDI-Device Identifier: M701TVEX282845J1
• UDI-Public: +M701TVEX282845J1/$$3190725FS04131676D
• 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: 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,Followup
• Report Date (Section B): 10/05/2022

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: 07/31/2019
• Device Model Number: TV-EX282845-J
• Device Catalogue Number: TV-EX282845-J
• Device Lot Number: FS041316-76
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 01/23/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/21/2022; 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2016
• 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: AFX VELA SUPRARENAL, #1510589023; AFX2 BIFURCATED STENT GRAFT, #1473690007; OVATION IX EXTENDER, #FS072616-26
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male