OVATION IX TV-AB2980-I

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for OVATION IX TV-AB2980-I manufactured by Endologix Santa Rosa.

Event Text Entries

[185884471] 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 remains implanted.
Patient Sequence No: 1, Text Type: N, H10


[185884472] An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm. Post polymer fill of the aortic body stent graft, the patient experienced an anaphylactic shock leading to a fatal outcome. The device will not be returned as it is still implanted in the patient, no further information was provided but had been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008011247-2020-00050
MDR Report Key9908803
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-04
Date of Event2020-02-27
Date Mfgr Received2020-03-04
Device Manufacturer Date2020-01-09
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 Street3910 BRICKWAY BLVD ,
Manufacturer CitySANTA ROSA CA 95403
Manufacturer CountryUS
Manufacturer Postal95403
Manufacturer Phone8009832284
Manufacturer G1ENDOLOGIX SANTA ROSA
Manufacturer Street3910 BRICKWAY BLVD ,
Manufacturer CitySANTA ROSA CA 95403
Manufacturer CountryUS
Manufacturer Postal Code95403
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOVATION IX
Generic NameMAIN BODY
Product CodeMIH
Date Received2020-03-31
Model NumberTV-AB2980-I
Lot NumberFS112619-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerENDOLOGIX SANTA ROSA
Manufacturer Address3910 BRICKWAY BLVD , SANTA ROSA CA 95403 US 95403


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-03-31

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