MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED

Model Number	BEA25-120/I16-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Blood Loss (2597); Patient Problem/Medical Problem (2688)
Date of Event	10/09/2016
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
It was reported a patient with a severely distended abdomen came in emergently on (b)(6) 2016 with a ruptured aortic aneurysm that was leaking a significant amount of blood into the retroperitoneum.The physician elected to treat the patient by implanting a bifurcated stent, an infrarenal aortic extension, and a suprarenal aortic extension.At the completion of the implant the physician was concerned with compartment syndrome, the significant amount of blood loss, as well as the prolonged ballooning of the aortic vessels; the physician had to explant the devices.The physician completed an open repair however, the patient expired on (b)(6) 2016, due to significant blood loss.
Additional Manufacturer Narrative
At the completion of the investigation, a clinical evaluation was not completed due to no patient medical records and no patient images available.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The event devices were returned for further evaluation and sample evaluation confirms that all devices were free of defects and showed no failure.Based on the information available, the root cause of the reported event is unknown.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX2
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6087173
• Report Number: 2031527-2016-00527
• Device Sequence Number: 1602517
• Product Code: MIH
• UDI-Device Identifier: 00818009014719
• UDI-Public: (01)00818009014719(17)170722
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2016

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: 07/22/2017
• Device Model Number: BEA25-120/I16-40
• Device Lot Number: 1526844-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2016
• Supplement Report FDA Received Date: 01/27/2017
• 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 AORTO UNI-ILIAC- 1580532-002; SUPRARENAL AORTA UNI-ILIAC- 1342245-010
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR