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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT
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ENDOLOGIX AFX; BIFURCATED STENT GRAFT Back to Search Results
Model Number BA28-80/I20-40
Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Leak/Splash (1354)
Patient Problem Failure of Implant (1924)
Event Date 11/27/2017
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
The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.A routine follow up showed the patient had a type 3a endoleak.The physician elected to implant a non-endologix cook device to seal the endoleak.The current patient status is unknown and was not reported to endologix.There have been no additional adverse events reported for this patient.
 
Event Description
Based on the information received at the completion of the clinical evaluation, there were substantial reported evidence that supported the following case event.It was confirmed that patient had a type 3a endoleak, main body buckling, and a secondary endovascular procedure done on (b)(6) 2017.In addition, clinical also found a complete component separation; cuff migration (1.5 cm); 3b of the cuff and superior stent cage dilation (28%).This will be reported in a separate report.The patient was discharged home in stable condition.No further information was provided.
 
Manufacturer Narrative
Based on the information received at the completion of the clinical evaluation, there were substantial reported evidence that supported the following case event.It was confirmed that patient had a type 3a endoleak, buckling of the main body, and a secondary endovascular procedure done on (b)(6) 2017.In addition, clinical also found a complete component separation; cuff migration (1.5 cm); 3b of the cuff and superior stent cage dilation (28%).Will be reported in a separate report.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent integrity of the cuff (breached), and the main body (superior stent margin) was the use of the strata material in combination with a progressive loss of overlap, likely cause by an extreme aortic and an iliac tortuosity.The complete component separation resulted in a loss of seal.The resultant component remodeling likely caused the stent migration and near complete buckling of the main body stent.Intra-operatively, the buckling precluded the physician from performing a successful reline and an additional surgical femoral to femoral bypass (and an aui procedure) was needed to repair the system.The patient was discharged home in stable condition.A review of manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.
 
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Brand Name
AFX
Type of Device
BIFURCATED STENT GRAFT
Manufacturer (Section D)
ENDOLOGIX
2 musick
irvine CA 92618
MDR Report Key7147497
MDR Text Key95808584
Report Number2031527-2017-00693
Device Sequence Number1
Product Code MIH
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
Type of Report Initial,Followup
Report Date 11/27/2017
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 Date02/28/2017
Device Model NumberBA28-80/I20-40
Device Lot Number1101252-030
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/27/2017
Initial Date FDA Received12/27/2017
Supplement Dates Manufacturer Received11/27/2017
Supplement Dates FDA Received03/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
VELA INFRARENAL- 1164476-014; VELA INFRARENAL- 1164476-014
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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