• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ENDOLOGIX AFX; VELA SUPRARENAL Back to Search Results
Model Number A28-28/C75-O20V
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problems Death (1802); Failure of Implant (1924); Occlusion (1984); Heart Failure (2206)
Event Date 03/25/2019
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 for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Immediately post initial case, an angiogram and ct revealed a type ia and type ii endoleaks.The physician then made several unsuccessful attempts to resolve the leaks, but ultimately decided to terminate the procedure and monitor the patient, who also had a heart attack after the case.Four (4) days post initial treatment, the patient passed away from cardiac complications.The physician commented that the patient had severe cardiac problems prior to the aaa intervention with several coronary stents implanted.In addition, after the patient's heart attack, the coronary stents became partially occluded, after which the patient's condition continued to worsen even with attempts to treat.
 
Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported event of an intraoperative type ia endoleak, heart attack, and death due to a lack of relevant medical records and images.The device, user, procedure, or anatomy relatedness of this event could not be determined; contributing factors for the reported type ia endoleak is most likely the off-label neck angle 170° (ifu states less than 60°).The procedure-related harms identified were a type ii endoleak from the lumbar artery.The final patient status was reported to be expired four days post the implant procedure most likely due to the pre-existing heart conditions.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.Device iteration is afx with duraply.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AFX
Type of Device
VELA SUPRARENAL
Manufacturer (Section D)
ENDOLOGIX
2 musick
irvine CA 92618
MDR Report Key8501428
MDR Text Key141521375
Report Number2031527-2019-00181
Device Sequence Number1
Product Code MIH
UDI-Device Identifier00818009014740
UDI-Public(01)00818009014740(17)191003
Combination Product (y/n)N
PMA/PMN Number
P040002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/25/2019
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
Device Operator Health Professional
Device Expiration Date02/07/2022
Device Model NumberA28-28/C75-O20V
Device Lot Number2058935-008
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/25/2019
Initial Date FDA Received04/10/2019
Supplement Dates Manufacturer Received03/25/2019
Supplement Dates FDA Received06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AFX-VELA SUPRARENAL:2058935-008; AFX2 BIFURCATED STENT GRAFT: 1993838-005; AFX-VELA SUPRARENAL: 2058935-008
Patient Outcome(s) Death;
-
-