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

Model Number	TV-IL1412160-J
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/08/2020
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 an ovation ix stent graft system and an additional limb extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure during a routine follow up, a computerized tomography (ct) image revealed a type a type 1b endoleak on the left common iliac artery.The patient is reportedly doing fine and awaiting re-intervention.
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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 type 1b endoleak due to cephalic left limb stent migration into the sac.This is 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.The final patient status was reported being stable post the re-intervention.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.Corrections: b2: outcomes attributed to adverse events has been updated.B5: describe event or problem has been updated.E1: customer contact has been updated.G1/g2: contact office - name has been updated.G4: date of received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially implanted with an ovation ix stent graft system and an additional limb extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure during a routine follow up, a computerized tomography (ct) image revealed a type a type 1b endoleak on the left common iliac artery.The patient is reportedly doing fine and awaiting re-intervention.Additional information: the physician elected to implant two (2) iliac limbs to resolve the type 1b endoleak.The patient was reported as doing well post secondary procedure.

• 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: 11024084
• Report Number: 3008011247-2020-00146
• Device Sequence Number: 1256661
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412160J1
• UDI-Public: +M701TVIL1412160J1/$$3200417FS03221706H
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/09/2020

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: 04/17/2020
• Device Model Number: TV-IL1412160-J
• Device Catalogue Number: TV-IL1412160-J
• Device Lot Number: FS032217-06
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/26/2021
• 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 FS031117-60; ILIAC LIMB, LOT FS041916-43; MAIN BODY, LOT FS060917-64; POLYMER, LOT FF032017-01; ILIAC LIMB, LOT FS031117-60; ILIAC LIMB, LOT FS041916-43; MAIN BODY, LOT FS060917-64; POLYMER, LOT FF032017-01
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR