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

Model Number	TV-IL1412160-J
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/13/2020
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 afx2 bifurcated stent graft and two (2) ovation ix limb stent graft extensions to treat an abdominal aortic aneurysm (aaa).This initial procedure is outside the intended of use due to adjunctive devices not compatible with afx2 stent.Approximately seven (7) months later, a computed tomography angiogram (cta) had identified that the ovation ix left limb stent graft had migrated into the iliac aneurysm causing a type 1b endoleak with aneurysm enlargement of the left iliac artery.The physician completed a successful re-intervention with implanting an additional ovation ix limb stent graft.The patient was reported as doing well post intervention.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned therefore no evaluation was completed.At the completion of the clinical assessment, the left limb stent-graft cephalic migration, 1b endoleak, secondary endovascular procedure event were confirmed from the medical records.Procedure-related harms, device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.As the initial procedure is outside the intended of use due to adjunctive devices not compatible per the ifu, this is most likely cause the migration of the stent resulting in a type 1b endoleak.The final patient status was reported to be stable.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Corrections: h6: result code: remove code 3233.H6: conclusion code: remove code 11.

• 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: 10143566
• Report Number: 3008011247-2020-00068
• Device Sequence Number: 2438516
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412160J1
• UDI-Public: +M701TVIL1412160J1/$$3220403FS03061921F
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 04/03/2022
• Device Model Number: TV-IL1412160-J
• Device Catalogue Number: TV-IL1412160-J
• Device Lot Number: FS030619-21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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: AFX2 BIFURCATED STENT GRAFT, LOT 2022247-004; OVATION IX, ILIAC LIMB, LOTFS091917-01; AFX2 BIFURCATED STENT GRAFT, LOT 2022247-004; OVATION IX, ILIAC LIMB, LOTFS091917-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR