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	Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924)
Date of Event	12/12/2019
Type of Reportable Event	Serious Injury
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.Devices remain implanted in patient.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the ovation ix abdominal aortic aneurysm stent.Post externalized crossover wire, the patient experienced hypotension and was successfully treated for an anaphylactic reaction per the device ifu.At the conclusion of the procedure, the aneurysm was confirmed successfully excluded.The physician will continue to monitor the patient.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported polymer leak is unconfirmed due to a lack of relevant medical records and imaging.Request was made for medical records; however, denied due to patient authorization requirements and only pre-procedure medical imaging was received.Definitive device, user, or anatomy relatedness of this event could not be determined; however, the reported resistance could have contributed to the polymer leak.The procedure related harm identified was hypotension.The final patient status was reported to be under surveillance after a successful endovascular procedure.As identified in 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 this fsn, this is the most likely cause associated with this event.On 06aug2018, endologix issued a field safety notice (fs-0009) regarding the risk of polymer leak events with the ovation ix aortic body stent graft.On 06may2020, 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.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.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: 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: 9559190
• Report Number: 3008011247-2020-00004
• Device Sequence Number: 11341493
• Product Code: MIH
• UDI-Device Identifier: M701TVAB2680J1
• UDI-Public: +M701TVAB2680J1/$$3220909FS09041935I
• 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,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

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: 09/09/2022
• Device Model Number: TV-AB2680-J
• Device Catalogue Number: TV-AB2680-J
• Device Lot Number: FS090419-35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/07/2020
• 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: OVATION IX ILIAC LIMB FS010219-39.; OVATION IX ILIAC LIMB FS092319-01.; OVATION PRIME FILL POLYMER FF092419-01.; OVATION IX ILIAC LIMB FS010219-39; OVATION IX ILIAC LIMB FS092319-01; OVATION PRIME FILL POLYMER FF092419-01
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR