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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENDOLOGIX AFX; LIMB STENT GRAFT
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ENDOLOGIX AFX; LIMB STENT GRAFT Back to Search Results
Model Number I20-13/C88F SA
Device Problem Unintended Movement (3026)
Patient Problem Failure of Implant (1924)
Event Date 07/28/2021
Event Type  Injury  
Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a 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 treated for an abdominal aortic aneurysm (aaa) with an afx bifurcated stent graft, an afx limb stent graft in the external iliac and an afx vela suprarenal.Approximately five and a half (5.5) years post initial procedure, angiogram revealed that due to remodeling, the distal attachment side of the extension pulled back into the common iliac artery aneurysm.To re-achieve a distal seal, the physician elected to extend to the external iliac with implant of an ovation ix iliac limb.In addition, an afx limb stent graft was placed on top of the ovation ix iliac limb, sealing very well inside the previously implanted afx limb stent graft extension.The procedure was completed without incident.Final angiogram showed a very good proximal and distal seal, and exclusion of the common iliac artery aneurysm.Patient did very well intra- and post-operatively and was discharged home the following day.
 
Event Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx bifurcated stent graft, an afx limb stent graft in the external iliac and an afx vela suprarenal.Approximately five and a half (5.5) years post initial procedure, angiogram revealed that due to remodeling, the distal attachment side of the extension pulled back into the common iliac artery aneurysm.To re-achieve a distal seal, the physician elected to extend to the external iliac with implant of an ovation ix iliac limb.In addition, an afx limb stent graft was placed on top of the ovation ix iliac limb, sealing very well inside the previously implanted afx limb stent graft extension.The procedure was completed without incident.Final angiogram showed a very good proximal and distal seal, and exclusion of the common iliac artery aneurysm.Patient did very well intra- and post-operatively and was discharged home the following day.Corrected information: the patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx bifurcated stent graft, an afx limb stent graft in the external iliac and an afx vela suprarenal.Approximately five and a half (5.5) years post initial procedure, an angiogram revealed, the distal attachment side of the extension pulled back into the common iliac artery aneurysm causing a 3a endoleak.An intervention was performed.To re-achieve a distal seal, the physician elected to extend the external iliac with an ovation ix iliac limb.In addition, an afx limb stent graft was placed within the ovation ix iliac limb to assist in sealing the previously implanted afx limb stent graft extension.The procedure was completed without incident.Final angiogram showed a very good proximal and distal seal, and exclusion of the common iliac artery aneurysm.Patient was reported as doing well and was discharged on the first post operative day following a secondary endovascular procedure.
 
Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident-related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the left common iliac endoleak (type 1b) was identified to be a type 3a endoleak of the iliac components.This is moderately consistent with the reported adverse event/incident.The most likely causation for the type 3a endoleak is anatomy-related due to the iliac diameter being off-label; iliac artery remodeling occurred increasing the angulation from 38 to 91 degrees.The final patient status was reported as discharged on the first post-operative day following a secondary endovascular procedure.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Corrections: b5: describe event or problem.G4: date received by manufacturer-updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
 
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Brand Name
AFX
Type of Device
LIMB STENT GRAFT
Manufacturer (Section D)
ENDOLOGIX
2 musick
irvine CA 92618
MDR Report Key12318417
MDR Text Key266396301
Report Number2031527-2021-00305
Device Sequence Number1
Product Code MIH
UDI-Device Identifier00818009011459
UDI-Public(01)00818009011459(17)180619
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 Other
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/19/2018
Device Model NumberI20-13/C88F SA
Device Lot Number1352059003
Was Device Available for Evaluation? No
Date Manufacturer Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AFX BIFURCATED STENT GRAFT (LN: 1397314011).; AFX VELA SUPRARENAL (LN: 1252424031).; AFX BIFURCATED STENT GRAFT (LN: 1397314011); AFX VELA SUPRARENAL (LN: 1252424031)
Patient Outcome(s) Required Intervention;
Patient Age78 YR
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