MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C95-O20V
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	06/24/2018
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
On (b)(6) 2015, the patient was implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm.On (b)(6) 2018, the patient was presented to the er with a ruptured aaa.The physician was attempting to re-line the stent graft which had a type 3b endoleak when the patient's condition deteriorated and the physician felt it necessary to convert to an open repair and explant of the afx graft.The patient is in icu with poor prognosis.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned but two (2) photos were taken from the same angle giving on one view of the device.A large hole was present in the body of the graft.Based on information obtained within the photo, the cause of the hole cannot be determined.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events of a rupture abdominal aortic aneurysm (aaa), a type 3b of the suprarenal cuff (breached), open repair and explant of the device.Device, user, procedure or anatomy relatedness and procedure related harms of this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be in poor prognosis post the open repair procedure.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7717013
• Report Number: 2031527-2018-00608
• Device Sequence Number: 1315474
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)180408
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2018
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1252432-013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2018
• Supplement Date Received by Manufacturer: 06/24/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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: BIFURCATED STENT GRAFT, LOT # 1252304014; SUPRARENAL EXTENSION, LOT # 1252432-013
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR