MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; BIFURCATED

Model Number BEA25-120/I16-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 10/09/2016

Event Type  Death  

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 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.

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
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6087173
• MDR Text Key: 59409663
• Report Number: 2031527-2016-00527
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014719
• UDI-Public: (01)00818009014719(17)170722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INFRARENAL AORTO UNI-ILIAC- 1580532-002; SUPRARENAL AORTA UNI-ILIAC- 1342245-010
• Patient Outcome(s): Death
• Patient Age: 75 YR