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

Model Number TV-IL1412160-J

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Rupture (2208)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Endologix will continue to investigate the reported event.The patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.

Event Description

An ovation ix abdominal stent graft system, two additional ovation ix iliac limbs, a non- endologix hypo stent and non- endologix coils were implanted to treat an abdominal aortic aneurysm (aaa).The right side was treated with the (non- endologix) hypo covered stent implanted parallel to the second ovation ix iliac limb (hypo-snorkel procedure) which was placed distal of the first ovation ix iliac limb.The left side was treated with the second ovation ix iliac limb which was placed to further extend in addition to non-endologix coils.The initial procedure was outside the indications of use (off- label).Approximately 14 (fourteen) months post-op, a type 3a endoleak and a type 2 endoleak with complete component separation on the right side between the two ovation ix iliac limbs and the non- endologix hypo covered stent was identified.Two (2) days post identified adverse event and device malfunction, the right iliac ruptured and emergency re-intervention was performed.The physician elected to implant two additional ovation ix iliac limbs across the separated ovation ix iliac limbs and coils (non- endologix).The patient was reported as doing well post-secondary procedure.

Manufacturer Narrative

Clinical assessment was completed based on the received medical records.The reported right iliac artery rupture was unconfirmed due to a lack of relevant imaging and medical records.Requests were made; however, denied due to patient authorization requirements.The type ii endoleak of the internal mesenteric artery was confirmed.This event is most likely anatomy related.The type iiia endoleak of the right iliac was confirmed by still images only.This event is most likely user related due to off label concomitant use of a non endologix stent in the right internal iliac artery.Procedure related harms for this could not be determined.The final patient status was reported to be doing well after a secondary endovascular procedure to repair the reported right iliac rupture.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.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: b6: relevant tests/laboratory data, including date - removed (b)(6) 2019: ct.

• Brand Name: OVATION IX
• Type of Device: ILIAC LIMB
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8610102
• MDR Text Key: 145114824
• Report Number: 3008011247-2019-00080
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: M701TVIL1412160J1
• UDI-Public: +M701TVIL1412160J1/$$3200824FS08161703O
• Combination Product (y/n): N
• PMA/PMN Number: P120006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2020
• Device Model Number: TV-IL1412160-J
• Device Catalogue Number: TV-IL1412160-J
• Device Lot Number: FS081617-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OVATION IX ILIAC LIMB (LN FS011717-47).; OVATION IX ILIAC LIMB (LN FS031117-57).; OVATION IX ILIAC LIMB (LN FS033017-04).; OVATION IX MAIN BODY (LN FS121517-82).
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR