MAUDE Adverse Event Report: ENDOLOGIX (TRIVASCULAR INC.) OVATION IX; MAIN BODY

Model Number	TV-AB2380-J
Medical Device Problem Codes	Use of Device Problem (1670); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Death (1802); Occlusion (1984); Pain (1994); Rupture (2208)
Date of Event	01/03/2019
Type of Reportable Event	Death
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.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent; intraoperative occlusion and ruptured right external iliac was noted and resolved after a gore viabhan (non-endologix) device and ovation 12x80 limb were implanted across the ruptured area, which showed good flow on final angiogram.The patient was then taken to the intensive care unit (icu) in stable condition.The following morning, patient complained of leg and back pain and ct showed re-occlusion of the graft.The patient was brought back to the operating room (or) and a sheath was advanced to the bifurcation graft; the physician elected to leave an infusion catheter and drip tpa for 24 hours.The patient decompensated late in the evening and passed away.
Event or Problem Description
Additional information received per clinical assessment confirming that the patient had pre-existing calcific disease prior to the initial implant (off-label use).
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: rupture of the right external iliac artery, intraoperative superior femoral artery occlusion, subsequent re-occlusion, and ultimate patient death.The complaint is most likely user-related due to the extensive calcifications within the patients iliac and femoral systems, causing significantly narrowed luminal diameters.In addition, multiple angioplasties were required to gain femoral access at the initial evar procedure, and it was noted that the pre-existing femoral lumen collapsed following sheath removal, necessitating the secondary surgical procedure (endartectomy).The discharge.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR INC.); 3910 brickway blvd.; santa rosa CA 95403
• MDR Report Key: 8284655
• Report Number: 3008011247-2019-00014
• Device Sequence Number: 19430519
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3210914FS091018503
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2021
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS091018-50
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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:FS022318-36; OVATION IX-ILIAC LIMB:FS092118-63; OVATION IX-ILIAC LIMB:FS101918-49; OVATION IX-ILIAC LIMB:FS022318-36; OVATION IX-ILIAC LIMB:FS092118-63; OVATION IX-ILIAC LIMB:FS101918-49
• Outcome Attributed to Adverse Event: Death
• Patient Age: 85 YR