MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-120/I20-40
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft to treat an abdominal aortic aneurysm.Approximately four (4) years post initial implant during review of a patients follow-up ct scan revealed aneurysm sac growth (>10cm).The physician elected to perform a secondary procedure to resolve the issue.The patient condition post-secondary procedure has not been provided.No further additional information or patient sequelae has been reported at this time.
Event or Problem Description
Additional information received per clinical assessment confirming that multiple type ii endoleaks were present at the time of the reported event.In addition, patient had a chronic thrombotic condition prior to the initial implant.Based on this additional information, there is no alleged deficiency related to an endologix device, and this is no longer a reportable event.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported event of aneurysm sac growth of 17mm.The event is most likely anatomy-related due to multiple type ii endoleaks from the lumbar.The clinical assessment also determined that there was evidence to reasonably suggest right lower leg ischemia with thrombus occurred that was not included in the event as reported, discovered during review of the 47-month post-implant ct scan.The ischemia and thrombus immediately postoperative was likely related to a chronic thrombotic condition.In addition, the patient had a fasciotomy and ankle thrombectomy the following day.The procedure-related harms identified were ischemia (right lower leg), additional endovascular procedure (thrombectomy), additional surgical procedure (fasciotomy), and abnormal blood loss.The final patient status was reported to be discharged on post operative day 14 to a nursing facility for rehabilitation.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8453492
• Report Number: 2031527-2019-00145
• Device Sequence Number: 2989520
• Product Code: MIH
• UDI-Device Identifier: 00818009011985
• UDI-Public: (01)00818009011985(17)170923
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: 09/23/2017
• Device Model Number: BA25-120/I20-40
• Device Lot Number: 1278499-025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR