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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/C70F SA
Device Problems Complete Blockage (1094); Device-Device Incompatibility (2919)
Patient Problem Occlusion (1984)
Event Date 02/04/2020
Event Type  Injury  
Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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, a suprarenal stent graft extension, and a limb stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure the left limb of the endograft was occluded.Re-intervention was completed.The physician performed a femoral-femoral bypass.No further information provided.
 
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.An evaluation of the device could not be completed.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 that the left limb occlusion complaint is confirmed.This is consistent with the reported adverse event/incident.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.During the investigation, endologix found reasonable evidence to suggest the device was used off-label.There was concomitant product use in the left iliac artery due to kinking that was noted at the index procedure.It is unclear how much this contributed to the reported occlusion.The patient will continued to be montiored.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.B5: describe event or problem - updated g1,2: contact office- name has been updated g3: report source - remove company representative g4: awareness date - updated h6: result code ¿ remove 3221 h6: conclusion code ¿ remove 11 device iteration is afx with duraply.
 
Event Description
The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extension, and a limb stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately four (4) years post initial procedure the left limb of the endograft was occluded.Re-intervention was completed.The physician performed a femoral-femoral bypass.No further information provided.Note: this patient is part of a clinical study.
 
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Brand Name
AFX
Type of Device
LIMB STENT GRAFT
Manufacturer (Section D)
ENDOLOGIX
2 musick
irvine CA 92618
MDR Report Key11216484
MDR Text Key258646272
Report Number3008011247-2021-00006
Device Sequence Number1
Product Code MIH
UDI-Device Identifier00818009011442
UDI-Public(01)00818009011442(17)180821
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 12/28/2020
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 Date08/21/2018
Device Model NumberI20-13/C70F SA
Device Lot Number1253175024
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/28/2020
Initial Date FDA Received01/22/2021
Supplement Dates Manufacturer Received02/22/2021
Supplement Dates FDA Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Treatment
AFX BIFURCATED STENT GRAFT 1315861008; AFX VELA SUPRARENAL 1252488023
Patient Outcome(s) Required Intervention;
Patient Age73 YR
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