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

Model Number	TV-AB2980-J
Medical Device Problem Codes	Fluid/Blood Leak (1250); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924)
Date of Event	09/19/2019
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 treated with the ovation ix abdominal stent graft system.Post polymer fill of the aortic body stent graft, the patient experienced hypotension and was successfully treated for an anaphylactic reaction per the device ifu.The aortic body fill channels did not appear filled a decision was made to implant a palmaz stent graft at the level of the sealing rings successfully achieving proximal seal.Difficulty was experience while attempting to cannulate the contralateral limb, the physician elected to conclude the procedure.One day post-op the patient underwent emergent fem-fem crossover bypass however, subsequently expired.The physician reported the patient had refused blood products.The cause of death was not initially reported.
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 intraoperative polymer leak with a severe anaphylactic reaction complaint is unconfirmed due to lack of the initial implant operative note.The ir +13 and 16 rings filled properly, 1st, 2nd, 3rd, 4th half rings did not fill, ipsi-lateral limb (left side) successfully deployed, blood loss, contra limb(right side) not implanted left untreated, emergent fem-fem bypass (b)(6) 2019 patient expired (b)(6) 2019 events are confirmed.The event is most likely user related due to the contra limb not implanted during initial implant, planned step procedure.Additionally, anatomy relatedness could not be determined due to lack of pre case planning computed tomography (ct) scan or report, however a tortuous aorta anatomy was reported.The procedure related harms identified were acute blood loss, anemia, acute renal failure, emergent additional surgical procedures (fem-fem bypass and placement of a dialysis catheter), hemodynamic instability and death.The refusal of the patient to receive blood products despite significant acute blood loss following the fem-fem bypass procedure (hemoglobin decreased from 12.7 to 4.3) most likely contributed to this event.The acute blood loss was associated with the need for significant vasopressor support, contributing to acute renal failure, further contributing to the patient's declining condition.Additional contributing factors were contra limb (right limb) not implanted (user related) during the initial implant procedure most likely causing the loss of right lower leg pulse, necessitating an urgent surgical fem-fem bypass.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: AORTIC MAIN BODY
• Manufacturer (Section D): ENDOLOGIX (TRIVASCULAR); 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 9210141
• Report Number: 3008011247-2019-00156
• Device Sequence Number: 3107285
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2980J1
• UDI-Public: +M701TVAB2980J1/$$3220801FS073119013
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: 08/01/2022
• Device Model Number: TV-AB2980-J
• Device Catalogue Number: TV-AB2980-J
• Device Lot Number: FS073119-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 04/30/2020
• 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 CUSTOM SEAL FILL POLYMER; OVATION IX ILIAC LIMB; PALMAZ STENT GRAFT; OVATION CUSTOM SEAL FILL POLYMER; OVATION IX ILIAC LIMB; PALMAZ STENT GRAFT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR