MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number A34-34/C100V

Device Problems Loss of or Failure to Bond (1068); Material Invagination (1336); Leak/Splash (1354); Difficult to Remove (1528); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2017

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

The patient was initially treated with the afx2 abdominal aortic aneurysm stent; during this initial procedure, an intraoperative endoleak at an indeterminate origin occurred.It was also noted that the angle in the aortic neck caused the cuffs to slip down.A palmaz (non-endologix) stent was then implanted, but the physician was unable to achieve a complete seal.The patient left the operating room with the endoleak, and the physician will monitor to see if the leak resolves.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the following reported event: intraoperative indeterminate endoleak and difficulty to withdraw the nose cone.The stent movement and use of the palmaz (non-endologix) stent is confirmed.The complaint is most likely user-related; contributing factors include the off label neck.Procedure related harms for this complaint could not be determined.The final patient status was not reported.In addition, the clinical assessment determined that there was evidence to reasonable suggest stent buckling of the infrarenal cuff and the proximal suprarenal cuff superior stent margins with type ii endoleak from the inferior mesenteric artery, which were not included in the event as reported.These discoveries were observed on (b)(6) 2018, during the review of a two month post implant ct image study of 04/04/2017.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).Correction: remove lot 1625546-015 and add lot 1354810-031, (b)(4).

Event Description

Additional information received per clinical review and confirming stent buckling of the infrarenal cuff, type ii endoleak, stent movement, and use of a non-endologix stent.

• Brand Name: AFX
• Type of Device: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7738820
• MDR Text Key: 115674074
• Report Number: 2031527-2018-00625
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014405
• UDI-Public: (01)00818009014405(17)170627
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2019
• Device Model Number: A34-34/C100V
• Device Lot Number: 1625546-015
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-VELA INFRARENAL-LOT 1625546-015; AFX-VELA SUPRARENAL-LOT 1626470-017; AFX-VELA SUPRARENAL-LOT 1626470-020; AFX2-AFX2 BIFURCATED STENT GRAFT:1354810-031; AFX-VELA INFRARENAL-LOT 1625546-015; AFX-VELA SUPRARENAL-LOT 1626470-017; AFX-VELA SUPRARENAL-LOT 1626470-020
• Patient Outcome(s): Other
• Patient Age: 82 YR