MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-60/I13-40
Medical Device Problem Codes	Off-Label Use (1494); Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident sample has not been received for evaluation.If the sample is received or 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 an afx2 bifurcated stent graft and two (2) ovation ix extenders to treat aortoiliac occlusive disease (aiod).This case is outside the indications of use (off -label).During this initial procedure an angiogram was performed and the graft was found to be covering the renal arteries.Attempts were made to pull the graft distally without success.The physician decided to explant the devices.The device was explanted without complication and the patient is reported to be recovering well.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events of malposition of the main body graft, unsuccessful endovascular procedure and conversion to an open repair procedure.The procedure related harm identified was a prolonged hospital stay and surgical conversion.The final patient status was discharged home as stable on the ninth post-operative day.These events are most likely user related due to off label severe aortoiliac occlusive disease (aiod) disease with 90% occlusion at the bifurcation.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.Device iteration is afx2.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8500394
• Report Number: 2031527-2019-00176
• Device Sequence Number: 16843760
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)20002016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2020
• Device Model Number: BEA22-60/I13-40
• Device Lot Number: 2056696-005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 09/30/2019
• 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 IX, EXTENDER, LOT FS040518-22; OVATION IX, EXTENDER, LOT FS040716-30; OVATION IX, EXTENDER, LOT FS040518-22; OVATION IX, EXTENDER, LOT FS040716-30
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR