FDA.reportPublic FDA data

MAUDE MDR 9908795

MDR report key
9908795
Report number
3008011247-2020-00051
Event key
0
Event type
3
Date of event
2020-03-04
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. EMILE PINSONNEAULT
Address
3910 BRICKWAY BLVD , SANTA ROSA CA 95403 US
Phone
800-800-8009
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OVATION IXAORTIC BODYENDOLOGIX SANTA ROSAMIHTV-AB2680-IFS081219-03R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

N

Patient 1

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.

D

Patient 1

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 HYPOTENSION AND WAS SUCCESSFULLY TREATED FOR AN ANAPHYLACTIC REACTION PER THE DEVICE IFU. AS NO POLYMER APPEARED IN THE PROXIMAL RINGS, A MEDTRONIC (NON-ENDOLOGIX) PROXIMAL STENT AND AN ADDITION OVATION LIMB WERE IMPLANTED. THE CASE CONCLUDED WITHOUT ADDITIONAL NEGATIVE PATIENT SEQUELAE AND THE ANEURYSM WAS EXCLUDED. THE PATIENT WILL CONTINUE TO BE MONITORED.