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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

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ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT Back to Search Results
Model Number BEA25-100/I20-40
Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problems Death (1802); Occlusion (1984); Renal Failure (2041); Heart Failure (2206); Rupture (2208)
Event Date 04/22/2019
Event Type  Death  
Manufacturer Narrative
The device involved in this event will not be returned for evaluation.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
During an re-intervention for non-endologix devices, an afx2 bifurcated stent graft was implanted to treat an occlusion of the right common iliac limb.This procedure is outside the indications of use (off- label).The patient was reported to have renal failure, serum creatinine of 7.6 after dialysis, stenosis, and a highly calcified left common iliac internal iliac.The physician elected to create an aorto-uni-iliac (aui) using the bifurcated stent graft.After the bifurcated stent graft was implanted, the nose cone would not retract distally for removal and several attempts were made to remove the device.The iliac subsequently tore in half while removing the delivery sheath.An emergency laparotomy was performed with a hemo-shield dacron (non-endologix) graft sewn in place and the physician was able to control the bleeding.However, the patient then went into cardiac arrest and expired during the procedure.
 
Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: total right common iliac artery (rcia) occlusion (pre-operative), difficulty in retracting the nosecone, left common iliac artery (lcia) rupture, subsequent transition to an open repair, and death.These events are most likely user-related due to the off-label use with a noncomitant product (left common iliac stent) and utilizing the bifurcated stent as an aorto-uni-iliac (aui) device by ligating the limb with silk ties.The inability to remove the nosecone and resultant iliac rupture was related to the pre-existing non-endologix stent.The cause of the surgical conversion and death was the left iliac rupture.The procedure-related harms identified were the rupture, surgical conversion, abnormal blood loss, cardiopulmonary resuscitation (cpr), intraoperative open repair, and death.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 afx2.
 
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Brand Name
AFX2
Type of Device
AFX2 BIFURCATED STENT GRAFT
Manufacturer (Section D)
ENDOLOGIX
2 musick
irvine CA 92618
Manufacturer (Section G)
ENDOLOGIX
2 musick
irvine CA 92618
Manufacturer Contact
victor arellano
2 musick
irvine, CA 92618
9495984671
MDR Report Key8579356
MDR Text Key144013916
Report Number2031527-2019-00219
Device Sequence Number1
Product Code MIH
UDI-Device Identifier00818009014672
UDI-Public(01)00818009014672(17)190913
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/22/2019
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? No
Device Operator Health Professional
Device Expiration Date09/13/2019
Device Model NumberBEA25-100/I20-40
Device Lot Number1986820-008
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/22/2019
Initial Date FDA Received05/03/2019
Supplement Dates Manufacturer Received04/22/2019
Supplement Dates FDA Received07/09/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age78 YR
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