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

Model Number	TV-AB2680-J
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924)
Date of Event	03/11/2020
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.Device remains implanted.
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 without additional negative patient sequelae and the aneurysm was excluded.The patient was reported as stable and will continued to be 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 evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; several requests were made and a denied response was received.The reported polymer leak is therefore unconfirmed.The procedure-related harm identified was transient hypotension due to the polymer leak that was successfully treated.The 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 not reported.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.H6 patient code; remove 1908.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: 9935517
• Report Number: 3008011247-2020-00056
• Device Sequence Number: 19021279
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3230130FS01292004Z
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 01/30/2023
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS012920-04
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/08/2020
• 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 FS012720-50.; ILIAC LIMB, LOT FS020320-32.; POLYMER, LOT FF100319-01.; ILIAC LIMB, LOT FS012720-50; ILIAC LIMB, LOT FS020320-32; POLYMER, LOT FF100319-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR