MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number	TV-AB2980-J
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/23/2020
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.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 the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately (1) month post initial procedure, a routine follow up ct (computed tomography) identified a type 1a endoleak.The patient is currently stable and is being monitored.
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 was completed.An examination of medical records and/or medical imaging received by endologix shows that the type 1a endoleak complaint is confirmed.The most likely causation for type 1a endoleak user relates due to the off label - concomitant use with products outside the ifu.Non- endologix stents were identified to be implanted in the aorta and iliac arteries at the initial procedure.The final patient status was reported being under surveillance.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: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10306264
• Report Number: 3008011247-2020-00078
• Device Sequence Number: 13654290
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3221121FS111919177
• Combination Product (Y/N): N
• Initial Reporter State: OK
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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: 11/21/2022
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS111919-17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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: ILIAC LIMB, LOT FS031320-12; ILIAC LIMB, LOT FS032620-36; ILIAC LIMB, LOT FS101619-09; ILIAC LIMB, LOT FS120619-16; POLYMER, LOT FF021120-01; ILIAC LIMB, LOT FS031320-12; ILIAC LIMB, LOT FS032620-36; ILIAC LIMB, LOT FS101619-09; ILIAC LIMB, LOT FS120619-16; POLYMER, LOT FF021120-01
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR