MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; ILIAC LIMB

Model Number	TV-IL1412160-J
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported 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 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.An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.No records were available per the device deficiency report.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.Though a root cause cannot be definitively determined, it was reported that the left hypogastric artery was occluded prior to the evar and the right hypogastric artery was occluded with coils during the evar.The inability to preserve one hypogastric artery is a cautionary product use condition and very likely could have caused the buttock ischemia.The final patient status remains unknown.The final patient status was not made available to endologix.No additional investigation of this reported 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 incidents.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of the alto abdominal stent graft system on (b)(6) 2023.The 30 (thirty) day routine confirmed buttock claudication.The patient will continue to be monitored.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• 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: 16872636
• Report Number: 3008011247-2023-00053
• Device Sequence Number: 20188706
• Product Code: MIH
• UDI-Device Identifier: 00850007370411
• UDI-Public: (01)00850007370411(17)250115(10)FS011422-54
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

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: 01/15/2025
• Device Model Number: TV-IL1412160-J
• Device Catalogue Number: TV-IL1412160-J
• Device Lot Number: FS011422-54
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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: ALTO MAIN BODY (LN FS070221-27); OVATION IX ILIAC LIMB (LN FS011422-51 )
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male