AFX A34-34/C100-O20 V

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for AFX A34-34/C100-O20 V manufactured by Endologix.

Event Text Entries

[188648259] The device involved in this 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.
Patient Sequence No: 1, Text Type: N, H10


[188648260] The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extensions and an ovation ix extender stent graft extension to treat an abdominal aortic aneurysm. This initial procedure is outside the indications of use due to the use of adjunctive devices not compatible with afx system per the ifu. Approximately 2 years post initial implant, dilation and movement of the proximal extension (suprarenal stent graft) was reported. An intervention was completed. The physician elected to implant another suprarenal stent graft extension to treat this event. The patient is doing well.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2031527-2020-00116
MDR Report Key9908805
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-03
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Device Manufacturer Date2017-07-05
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. EMILE PINSONNEAULT
Manufacturer Street2 MUSICK ,
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone8009832284
Manufacturer G1ENDOLOGIX
Manufacturer Street2 MUSICK ,
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAFX
Generic NameVELA SUPRARENAL
Product CodeMIH
Date Received2020-03-31
Model NumberA34-34/C100-O20 V
Lot Number1704634-013
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENDOLOGIX
Manufacturer Address2 MUSICK , IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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