MAUDE Adverse Event Report: ENDOLOGIX SANTA ROSA OVATION IX; MAIN BODY

Model Number	TV-AB2380-J
Medical Device Problem Codes	Complete Blockage (1094); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Death (1802); Occlusion (1984)
Date of Event	06/07/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially implanted with the ovation ix abdominal stent graft system to treat an abdominal aortic aneurysm (aaa).Approximately one (1) year post initial procedure, patient was present in the hospital in deep distress.A computed tomography angiography (cta) identified that both ovation ix aortic main bodies and limbs were completely occluded.It was reported that this patient is extremely obese and tested positive for methamphetamine use.The physician indicated that the methamphetamine use played a role in the grafts being completely clotting off.The physician stated that the patient still had blood flow to legs from retrograde flow from hypogastric arteries.It was reported that the patient expired three (3) days later ((b)(6) 2020) due to complication was rhabdomyolysis.
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 aortic and bilateral occlusion event is confirmed.Device, user, procedure or anatomy relatedness of this event could not be determined.The death event is confirmed.The procedure related harms identified were acute renal failure, paraplegia and acute respiratory failure.The death could not be determined due to inconclusive information.The reported methamphetamine use played a role in the aortic and iliac occlusion per the physician.There was no confirmation in the medical records of drug use.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: h6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: OVATION IX
• Common Device Name: MAIN BODY
• Manufacturer (Section D): ENDOLOGIX SANTA ROSA; 3910 brickway blvd; santa rosa CA 95403
• MDR Report Key: 10222333
• Report Number: 3008011247-2020-00076
• Device Sequence Number: 19439501
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3220205FS012519090
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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: 02/05/2022
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS012519-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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, LOT FS091018-57.; ILIAC LIMB, LOT FS102618-22.; POLYMER, LOT FF101518-02.; ILIAC LIMB, LOT FS091018-57.; ILIAC LIMB, LOT FS102618-22.; POLYMER, LOT FF101518-02.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 54 YR