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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED STENT GRAFT

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ENDOLOGIX, INC. AFX; BIFURCATED STENT GRAFT Back to Search Results
Model Number BA28-100/I16-40
Device Problems Collapse (1099); Material Puncture/Hole (1504)
Patient Problems Aneurysm (1708); Patient Problem/Medical Problem (2688)
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 afx with duraply.
 
Event Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately there (3) years post initial procedure, (exact date was not provided) a type 3b endoleak with sac growth was identified.An intervention was completed.The physician elected to reline the original implanted devices with an afx2 bifurcated stent graft, a vela suprarenal stent graft extension and two (2) ovation ix iliac limbs to resolve this reported event.The patient was reported as doing well post intervention.
 
Event Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately there (3) years post initial procedure, (exact date was not provided) a type 3b endoleak with sac growth was identified.An intervention was completed.The physician elected to reline the original implanted devices with an afx2 bifurcated stent graft, a vela suprarenal stent graft extension and two (2) ovation ix iliac limbs to resolve this reported event.The patient was reported as doing well post intervention.Additionally, clinical assessment determined there was evidence to reasonably suggest a type 2 endoleak of the lumbar (non device related failure) and distal stent buckling of the bifurcated stent graft.
 
Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported sac growth of 6mm and type iiib endoleak of the bifurcated stent graft were confirmed.Additionally, there was evidence to reasonably suggest a type ii endoleak of the lumbar (non device related failure) and distal stent buckling of bifurcated stent graft.The sac growth was likely related to the type iiib endoleak.The type iiib endoleak and stent buckling of the bifurcated stent graft causation was indeterminate.Device, user, procedure or anatomy relatedness of these events could not be determined.The final patient status was discharged on the second post operative day stable home following a secondary endovascular 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 afx with duraply.
 
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Brand Name
AFX
Type of Device
BIFURCATED STENT GRAFT
Manufacturer (Section D)
ENDOLOGIX, INC.
2 musick
irvine CA 92618
MDR Report Key8874466
MDR Text Key153692345
Report Number2031527-2019-00360
Device Sequence Number1
Product Code MIH
UDI-Device Identifier00818009010049
UDI-Public(01)00818009010049(17)171212
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/12/2019
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 Date12/12/2017
Device Model NumberBA28-100/I16-40
Device Lot Number1252327-017
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/12/2019
Initial Date FDA Received08/08/2019
Supplement Dates Manufacturer Received07/12/2019
Supplement Dates FDA Received06/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0006-2019
Patient Sequence Number1
Treatment
VELA SUPRARENAL, LOT 1252088016; VELA SUPRARENAL, LOT 1252088016
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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