MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-100/I16-40

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Stretched (1601)

Patient Problem Failure of Implant (1924)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

Patient was initially implanted with an afx bifurcated and vela suprarenal device in 2014.Recently, patient present with an endoleak type 1a.On (b)(6) 2018, the patient was relined with an ovation graft.The endoleak was successfully sealed and patient is in stable condition.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to refute the reported event of type ia endoleak.The clinical assessment determined that there was evidence to reasonably suggest the following: a non-endologix stent was implanted at index into the right iliac artery (off-label), there was multiple type ii endoleaks, and presence of stent cage dilation of the main body stent (28%) that were not included in the event as reported.These events were discovered during review of the event imaging study, 49 months post implant.Relatedness and procedure harms could not be determined.The patient was reported to be in stable condition.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).

Event Description

Additional information received refuting the reported type ia endoleak and rather, confirming multiple type ii endoleaks with stent cage dilcation of the main body.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8002735
• MDR Text Key: 124946477
• Report Number: 2031527-2018-00791
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013637
• UDI-Public: (01)00818009013637(17)141212
• 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: 09/20/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1055792-004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 10/26/2018
• Supplement Dates FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED-LOT: 1055792-004; AFX-VELA SUPRARENAL:12016850-002
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR