FDA.reportPublic FDA data

MAUDE MDR 9908772

MDR report key
9908772
Report number
2031527-2020-00121
Event key
0
Event type
3
Date of event
2020-03-03
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
2 MUSICK , IRVINE CA 92618 US
Phone
800-800-8009
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INTUITRAKBIFURCATED STENT GRAFTENDOLOGIXMIH25-16-120BLW10-1708-003R N

Patients#

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

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

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.