MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA22-60/I13-40
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Death (1802); Edema (1820); Failure of Implant (1924); Shock (2072); Respiratory Failure (2484)
Date of Event	06/28/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
To date the incident devices have not been received for evaluation.If the devices are received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
A patient with aortic iliac occlusive disease (aiod) was implanted with a bifurcated stent.Prior to the implant it was identified the patient had a small extravasation in the proximal aorta.After the placement of the bifurcated stent the patient was moved to post op where the patient had a drop in blood pressure.The patient was taken back to surgery and an angiogram showed the small extravasation was still present.The physician elected to implant an infrarenal aortic extension to resolve the issue.The patient's blood pressure returned to normal.Following the placement of the proximal extension the patient had swelling in the abdomen.The physician opened the abdomen, applied surgical mesh and the abdomen remained open for 3-4 days for the swelling to reduce.The abdomen was closed and on (b)(6) 2017 the patient expired.The physician believes the patient may have had a pulmonary embolism and/or the trauma of the procedure was too much.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the loss of seal could not be determined due to the lack of any medical records or imaging surrounding the event.It was likely that the extravasation was not excluded and/or there was an insufficient proximal seal immediately post initial implant of the bifurcated stent graft.There was intentional user error due to the off-label product use because of the patient's pre-existing occlusive disease.Additionally, there was a cautionary product use condition due to the pre-implant rupture.Procedure-related harms include: pulmonary embolus, surgical intervention to close the abdomen, and death due to aspiration pneumonia.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6803633
• Report Number: 2031527-2017-00421
• Device Sequence Number: 11155719
• Product Code: MIH
• UDI-Device Identifier: 00818009010131
• UDI-Public: (01)00818009010131(17)190810
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2017

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: 08/10/2019
• Device Model Number: BA22-60/I13-40
• Device Lot Number: 1511890-005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 11/03/2017
• 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: INFRARENAL AORTIC EXTENSION- 1298666-019
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 77 YR