INTUITRAK 25-16-120BL

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 INTUITRAK 25-16-120BL manufactured by Endologix.

Event Text Entries

[187899666] 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.
Patient Sequence No: 1, Text Type: N, H10


[187899667] The patient was initially implanted with a bifurcated stent graft and an infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa). Approximately 9. 5 years post initial procedure, a type 3a endoleak and thrombus in the abdominal aneurysm was identified. The patient has claudication in his hips and buttocks and three vessel coronary disease, the patient is currently receiving coronary artery bypass grafting (cabg) treatment and the abdominal aneurysm has shrunk in size.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2031527-2020-00121
MDR Report Key9908772
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 Date2010-06-14
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 NameINTUITRAK
Generic NameBIFURCATED STENT GRAFT
Product CodeMIH
Date Received2020-03-31
Model Number25-16-120BL
Lot NumberW10-1708-003
Device Expiration Date2013-05-31
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. Other 2020-03-31

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