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

Model Number	TV-IL1412160-J
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
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 ovation ix right iliac limb stenosis with additional endovascular procedure complaint is unconfirmed.This is not consistent with the reported adverse event/incident.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, it was determined that this was an off-label case as the right common iliac maximum diameter measured at 33.8mm and it should be 8-25mm.Additionally, there was absence of abdominal aortic aneurysm.Though the reported ovation ix right iliac limb stenosis with additional endovascular procedure could not be confirmed, and a definitive root cause cannot be determined, this may have contributed to them.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.
Event or Problem Description
On (b)(6) 2022, the patient was treated for an abdominal aortic aneurysm (aaa) with the implant of the alto abdominal stent graft system and an ovation ix extender in the left limb.Reportedly, prior to implant the right internal iliac artery was occluded.Approximately one (1) month post-procedure, right limb stenosis was identified at the follow-up.Reintervention took place; however, reintervention details were not provided.The patient status post-reintervention was not reported.
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 ovation ix right iliac limb stenosis is confirmed.The additional endovascular procedure complaint is unconfirmed.This is moderately consistent with the reported event.The clinical evaluation also shows reasonable evidence to suggest a type ii endoleak from the lumbar artery occurred that was not included in the event as reported.These findings were discovered during an examination of the undated post implant computerized tomography scan.The iliac limb stenosis is most likely user related as the right common iliac artery maximum diameter was 33.8mm (off-label) with minimal dilation of the aorta (33.5mm maximum diameter).It appears the alto was implanted for the right common iliac aneurysm (off label).The iliac diameter should be 8-25mm.Procedure related harms for this complaint 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.B5: describe event or problem - updated.G3: awareness date ¿ updated.H6: investigation finding codes - remove code 4247.H6: investigation conclusion codes - remove code 4315.
Event or Problem Description
On 10/13/2022, the patient was treated for an abdominal aortic aneurysm (aaa) with the implant of the alto abdominal stent graft system and an ovation ix extender in the left limb.Reportedly, prior to implant the right internal iliac artery was occluded.Approximately one (1) month post-procedure, right limb stenosis was identified at the follow-up.Reintervention took place; however, reintervention details were not provided.The patient status post-reintervention was not reported.After the initial report, additional information was received reporting that a gore vbx (non-endologix) 11x39mm stent graft was implanted at the reintervention performed on (b)(6) 2022.No additional information is available.Additionally, the clinical assessment determined that there was evidence to reasonably suggest a type ii endoleak from the lumbar artery (non-device related) occurred that was not included in the event as reported.

• 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: 16098541
• Report Number: 3008011247-2023-00005
• Device Sequence Number: 6717453
• Product Code: MIH
• UDI-Device Identifier: 00850007370411
• UDI-Public: (01)00850007370411(17)250518(10)FS051722-76
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 05/18/2025
• Device Model Number: TV-IL1412160-J
• Device Lot Number: FS051722-76
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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 FS081121-09); OVATION IX EXTENDER (LN FS061421-51); OVATION IX ILIAC LIMB (LN FS011822-44)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female