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

Model Number	TV-AB2380-J
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924)
Date of Event	03/26/2020
Type of Reportable Event	Serious Injury
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
An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.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 case concluded with an intraoperative type 1a endoleak.The physician elected to wait until the patients 30 day follow up to address the type 1a endoleak.The patient was reported as stable and is being monitored.
Additional Manufacturer Narrative
The manufacturing lot review confirmed all devices met specifications prior to release.The devices were not returned as they remain implanted, and therefore no sample evaluation was completed.A clinical assessment was completed based on the received medical records.The reported type ia endoleak and polymer leak were confirmed.The type ia endoleak was most likely user-related due to the off-label juxtarenal neck angulation of 78 degrees (ifu requirement is less than or equal to 60 degrees).The procedure-related harms identified were hemodynamic instability, respiratory failure (patient reportedly required reintubation post operatively), renal insufficiency (due to hypotension and acute tubular necrosis during the procedure), and a prolonged hospital stay.The postoperative respiratory failure was likely related to the prolonged hypotension in combination with the pre-existing lung disease.The renal insufficiency was most likely related to the prolonged hypotension, and the moderate left renal calcifications could have also contributed.The polymer leak event is most likely device-related as identified in field safety notice (fs-0012); the root cause for most polymer leaks is a material weakness adjacent to the polymer fill channel which may become compromised during pressurization with liquid polymer.Since this device remains implanted, endologix is unable to conduct product evaluation to conclusively ascertain root cause.However, based on the investigation associated with the fsn this is the most likely cause associated with this event.The final patient status was discharged on the sixth postoperative day at home stable.On 06 august 2018, endologix issued a field safety notice (fs-0009) regarding the risk of polymer leak events with the ovation ix aortic body stent graft.On 06 may 2020, endologix issued a follow-up safety update (fs-0012) reaffirming treatment recommendations for patients who experience a polymer leak during implantation and providing updated information on the current rate of polymer leaks, the rate of clinical harms and root cause.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 to g4, h6, h9: h6 result code; remove 3233 h6 conclusion code; remove 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: 9979975
• Report Number: 3008011247-2020-00060
• Device Sequence Number: 11285029
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2380J1
• UDI-Public: +M701TVAB2380J1/$$3221021FS10171917/
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: P120006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2022
• Device Model Number: TV-AB2380-J
• Device Catalogue Number: TV-AB2380-J
• Device Lot Number: FS101719-17
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FSN-0009, FSN-0012
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ILIAC LIMB, LOT # FS022620-31; ILIAC LIMB, LOT # FS022720-23; POLYMER, LOT # FF100819-01; ILIAC LIMB, LOT # FS022620-31; ILIAC LIMB, LOT # FS022720-23; POLYMER, LOT # FF100819-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR