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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT
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ENDOLOGIX AFX2; BIFURCATED STENT GRAFT Back to Search Results
Model Number BEA28-120/I20-40
Device Problems Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Unintended Movement (3026)
Patient Problems Aneurysm (1708); Failure of Implant (1924)
Event Date 05/14/2019
Event Type  Injury  
Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.
 
Event Description
The patient was initially implanted with a bifurcated stent graft and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately nine (9) months post initial procedure, a buckle (crumpled) bifurcated stent graft and migration of the infrarenal stent graft extension was reported.A snorkel procedure was performed to resolve this event.The patients status was not reported.The patient will continued to be monitored.
 
Event Description
The patient was initially implanted with a bifurcated stent graft and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately nine (9) months post initial procedure, a buckle (crumpled) bifurcated stent graft and migration of the infrarenal stent graft extension was reported.A snorkel procedure was performed to resolve this event.The patient status was not reported.The patient will continue to be monitored.Additionally, clinical assessment determined that there was evidence to reasonably suggest at the index procedure, an acute renal injury occurred, a type ia endoleak at the secondary endovascular procedure and sac growth of 8mm at the secondary procedure occurred that was not included in the event as reported.
 
Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported migration of the proximal extension into the aortic sac was confirmed by medical records only.The event is most likely user related due to the off label concomitant use of non endologix stents as well as the ruptured nature of the aneurysm during the index procedure likely contributed to these events.The reported secondary endovascular procedure to extend the superior mesenteric artery and left renal artery snorkels was confirmed.The procedure related harm identified was a prolonged procedure (>4hrs).The final patient status was discharged home on the seventh post-operative day and was reported home stable with home health.Additionally, clinical assessment determined that there was evidence to reasonably suggest at the index procedure, an acute renal injury occurred, a type ia endoleak at the secondary endovascular procedure and sac growth of 8mm at the secondary procedure occurred that was not included in the event as reported.The acute renal failure was user related due to sacrificing of the right renal artery during the index procedure.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted; therefore, no evaluation was completed.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx2.
 
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Brand Name
AFX2
Type of Device
BIFURCATED STENT GRAFT
Manufacturer (Section D)
ENDOLOGIX
2 musick
irvine CA 92618
MDR Report Key8687854
MDR Text Key147646631
Report Number2031527-2019-00270
Device Sequence Number1
Product Code MIH
UDI-Device Identifier00818009014399
UDI-Public(01)00818009014399(17)181206
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,health
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/06/2018
Device Model NumberBEA28-120/I20-40
Device Lot Number1765080-009
Was Device Available for Evaluation? No
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
VELA INFRARENAL, LOT 1754218-002; VELA INFRARENAL, LOT 1754218-002
Patient Outcome(s) Required Intervention;
Patient Age67 YR
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