MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A34-34/C100-O20 V
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted devices involved in this event have not be returned for evaluation.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
An afx bifurcated and suprarenal extensions (2) were initially implanted.I was informed yesterday of an explant of an afx graft.The patient returned three (3) years post-op showing evidence of a type ia endoleak and aneurysm enlargement; the sac was reported to have grown 2cm since initial implant.It was noted that the patient had not returned for follow-up for over three years.The physician elected to convert the patient to open surgical repair and explant the stent graft.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the following reported events: type ia endoleak, sac enlargement, and explant of the device.Procedure related harms and device, user, procedure or anatomy relatedness of this complaint could not be confirmed.The final patient status was reported to be in stable condition post the open surgical repair procedure.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.Correction: brand name, concomitant medical products.Concomitant medical products: remove 1314628-007 entry.Device code - remove 1068, 1354.Conclusion code - remove 11.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8122683
• Report Number: 2031527-2018-00906
• Device Sequence Number: 295106
• Product Code: MIH
• UDI-Device Identifier: 00818009010117
• UDI-Public: (01)00818009010117(17)180217
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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: 05/11/2018
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1341528-022
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 03/01/2019
• 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:1314628-007; AFX-VELA SUPRARENAL:1258817-016; AFX-VELA SUPRARENAL:1341528-022
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR