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

Model Number	TV-EX222245-J
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	10/04/2022
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 implanted with an afx2 bifurcated stent graft and an ovation ix extender to treat an abdominal aortic aneurysm (off -label due to concomitant use with products outside the ifu).Approximately 3 years post initial procedure, a type 1b endoleak and aneurysm enlargement (right iliac) was identified.The patient is pending re-intervention.
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 due to concomitant use with products outside the ifu).Approximately 3 years post initial procedure, a type 1b endoleak and aneurysm enlargement (right iliac) was identified.The patient is pending re-intervention.After the initial report, additional information was received that the physician was going to treat the patient with a medtronic (non-endologix) graft.It is unknown if the reintervention took place.
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 the device 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 right iliac aneurysm enlargement and type ib endoleak adverse events are unconfirmed.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.There was use of concomitant devices (ovation ix limb extension in right common iliac artery) which is outside the indications of use (off-label) due.Additionally, there was no abdominal aortic aneurysm, only a right common iliac aneurysm measuring 45mm (off label- should be 10-23mm).Though a definitive root cause cannot be determined, the off-label uses could have contributed to reported events.The final patient status was reported as stable.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.B5: describe event or problem - updated g3: awareness date ¿ updated h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.

• 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: 15673217
• Report Number: 3008011247-2022-00134
• Device Sequence Number: 20413321
• Product Code: MIH
• UDI-Device Identifier: M701TVEX222245J1
• UDI-Public: +M701TVEX222245J1/$$3220314FS01081941S
• 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: 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): 10/04/2022

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: 03/14/2022
• Device Model Number: TV-EX222245-J
• Device Catalogue Number: TV-EX222245-J
• Device Lot Number: FS010819-41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• 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, #2273065009
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male