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

Model Number	TV-IL141280-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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 the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial implant, following a computed tomography angiography (cta) scan, a type 1b endoleak of the right common iliac and a possible type 2 endoleak (non- device relate failure) were identified.The patient is scheduled for re-intervention.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial implant, following a computed tomography angiography (cta) scan, a type 1b endoleak of the right common iliac and a possible type 2 endoleak (non-device-related failure) were identified.The patient is scheduled for re-intervention.Additional information received indicating the scheduled re-intervention has been cancelled.
Additional Manufacturer Narrative
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.There are no other equivalent adverse events/incidents for this lot number existing within the endologix complaint handling system.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 ib endoleak of the right iliac artery and multiple type ii endoleaks from the lumbar and sacral arteries are confirmed.This is consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.Calcium was identified at the distal sealing zone of the right iliac limb and this may have contributed to the reported event.The final patient status was reported as being 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.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10755713
• Report Number: 3008011247-2020-00119
• Device Sequence Number: 3336063
• Product Code: MIH
• UDI-Device Identifier: M701TVIL141280J1
• UDI-Public: +M701TVIL141280J1/$$3180625FS06081523U
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 06/25/2018
• Device Model Number: TV-IL141280-J
• Device Catalogue Number: TV-IL141280-J
• Device Lot Number: FS060815-23
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OVATION IX ILIAC LIMB FS031616-36; OVATION IX MAIN BODY FS040717-59; OVATION PRIME FILL POLYMER FF062317-01; OVATION IX ILIAC LIMB FS031616-36; OVATION IX MAIN BODY FS040717-59; OVATION PRIME FILL POLYMER FF062317-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR