MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	02/13/2019
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 the completion of the investigation.
Event or Problem Description
The patient was initially treated with the afx abdominal aortic aneurysm stent.Approximately four (4) years post initial implant the patient presented to north mississippi medical center and was found to have migration of the graft (30mm) and aneurysm sac growth (unknown diameter).The physician elected to perform a secondary procedure where the device was successfully explanted from the patient.No further additional information or patient sequelae has been reported at this time.
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 a type ia endoleak.There was unsubstantial evidence to support the reported graft migration of 30mm and sac growth (sac measured at 72mm) due to a lack of comparative imaging; requests were made and no response was received.The procedure-related harms and device, user, procedure, or anatomy relatedness of this event could not be determined.The final patient status was reported to be doing well post open repair.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
Additional information received per medwatch report # mw5084272 confirming that the patient also presented with a type i endoleak (unspecified type ia or ib).Clinical assessment confirmed the presence of a type ia endoleak.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8410217
• Report Number: 2031527-2019-00123
• Device Sequence Number: 16221624
• Product Code: MIH
• UDI-Device Identifier: 00818009014160
• UDI-Public: (01)00818009014160(17)171020
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2015
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1277505-018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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: AFX-BIFURCATED STENT GRAFT:1283283-023; AFX-VELA INFRARENAL:1250786-003; AFX-VELA SUPRARENAL:1275404-013; AFX-VELA SUPRARENAL:1277505-019
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR