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

Model Number	TV-IL1428140-J
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Devices remain implanted in patient.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately two and a half (2.5) years post initial procedure, the patient presented at routine follow-up with a dislodged left iliac limb device and a type ib endoleak as detected by ct (computed tomography) scan.The physician plans to re-intervene but surgery has not been scheduled.The patient is reported in good condition.As of date, there have been no additional patient sequelae reported.
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 reported type ib endoleak of the left common iliac artery event and stent dislodgement (cranial migration into the aortic sac approximately 54mm) were confirmed.Additional, clinical assessment determined sac growth of 5mm of left common artery had occurred.These event are most likely user and anatomy related due to the left common iliac artery diameter was reported to be 26mm, per ifu should be between 8-25mm.No procedure related harms were identified.The final patient status was discharged home stable on the first post operative day following a secondary 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 event and similar events in the event further investigation is needed.Corrections: b2: outcomes attributed to adverse events has been updated, b5: describe event or problem , h6: method code: remove code 4114, h6: result code: remove code 3233, h6: conclusion code: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Approximately two and a half (2.5) years post initial procedure, the patient presented at routine follow-up with a dislodged left iliac limb device and a type ib endoleak as detected by ct (computed tomography) scan.The physician plans to re-intervene but surgery has not been scheduled.The patient is reported in good condition.As of date, there have been no additional patient sequelae reported.Additional information: a secondary endovascular procedure occurred on (b)(6) 2020.The physician elected to implant two (2) ovation limbs and coiling of left common iliac artery to resolve theses events.Additional findings sac growth of 5mm of left common artery occurred that was not included in the event as reported.

• 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: 9775110
• Report Number: 3008011247-2020-00036
• Device Sequence Number: 11316711
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1428140J1
• UDI-Public: +M701TVIL1428140J1/$$3200330FS04181672O
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 02/04/2020

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: 03/30/2020
• Device Model Number: TV-IL1428140-J
• Device Catalogue Number: TV-IL1428140-J
• Device Lot Number: FS041816-72
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 08/14/2020
• 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: OVATION IX ILIAC LIMB FS021317-47; OVATION IX MAIN BODY FS080417-49; OVATION IX ILIAC LIMB FS021317-47; OVATION IX MAIN BODY FS080417-49
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 69 YR