MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR) OVATION IX; ILIAC LIMB

Model Number	TV-IL1428160-J
Medical Device Problem Codes	Obstruction of Flow (2423); Patient-Device Incompatibility (2682); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Aneurysm (1708); Stenosis (2263)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.
Event or Problem Description
The patient was initially treated with the ovation ix abdominal aortic stent graft system.The patient had known tortuous iliac arteries.Approximately three (3) years post initial procedure, the patient presented emergently with a complaint of left foot pain.An angiography revealed the left common iliac appeared crumpled with the presence of a type ib endoleak and reduced flow through the left limb.The physician elected to treat the patient with ovation ix; two (2) additional iliac limbs and two (2) extensions.The re-intervention was reported as successful and the patient condition as well post-op.
Event or Problem Description
The patient was initially treated with the ovation ix abdominal aortic stent graft system.The patient had known tortuous iliac arteries.Approximately three (3) years post initial procedure, the patient presented emergently with a complaint of left foot pain.An angiography revealed the left common iliac appeared crumpled with the presence of a type ib endoleak and reduced flow through the left limb.The physician elected to treat the patient with ovation ix; two (2) additional iliac limbs and two (2) extensions.The re-intervention was reported as successful and the patient condition as well post-op.Additional information: the clinical assessment determined that there was evidence to reasonably suggest sac growth of 6.1mm occurred that was not included in the event as reported.The sac growth was discovered on (b)(6) 2019 during review of the event ct scan.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.The type ib endoleak with buckling of the left iliac stent with decreased flow and the retraction of the right iliac limb proximally were confirmed.Additionally, sac growth of 6.1mm was identified.The event is most likely anatomy related due to the increase in the infrarenal angulation from 42° to 68° (aortic remodeling).Procedure related harms for this event could not be determined.The final patient status was reported to be well after a successful endovascular procedure.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.

• Brand Name: OVATION IX
• Common Device Name: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9195117
• Report Number: 3008011247-2019-00154
• Device Sequence Number: 3660457
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1422100J1
• UDI-Public: +M701TVIL1422100J1/$$3190510FS030116127
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 05/10/2019
• Device Model Number: TV-IL1428160-J
• Device Catalogue Number: TV-IL1422100-J
• Device Lot Number: FS030116-12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 08/10/2020
• 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.; OVATION FILL POLYMER.; OVATION IX AORTIC MAIN BODY.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR