MAUDE MDR 1008190

MDR report key
1008190
Report number
1058196-2008-00072
Event key
0
Event type
3
Date of event
2008-01-31
Date received
2008-03-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
DR. GAURANG PATEL
Address
CORDIS CORPORATION 14201 N.W. 60TH AVENUE MIAMI LAKES FL 33014 US
Phone
786-786-7863
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NBCA LIQUID EMBOLIC KITCNV NBCA (MFE)CORDIS NEUROVASCULAR, INC.KGGNA631XXXUNKN*N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-03-050

Event Narratives#

D

Patient 1

DURING AN EMBOLIZATION OF AN ARTERIO-VENOUS MALFORMATION THE NBCA GLUE MIGRATED AND RESULTED IN PULMONARY EMBOLIZATION. IT WAS INITIALLY REPORTED BY A PATIENT'S MOTHER THAT TRUFILL DCS DETACHABLE COILS WERE PLACED IN THE CEREBRAL ARTERY ANEURYSM AND DURING THE PROCEDURE THE NBCA GLUE WENT THE WRONG WAY INTO THE BLOOD STREAM. TREATMENT INCLUDED ASPIRIN 81MG, THREE TIMES DAILY; RANITIDINE 150MG TABLET, TWICE DAILY P.O. A FEW DAYS LATER THE PATIENT SAW BOTH A CARDIOLOGIST AND PULMONOLOGIST. THE CARDIOLOGIST MEDICALLY CLEARED THE CHILD AND NO TREATMENT WAS PRESCRIBED. THE CHILD IS TO CONTINUE UNDER PULMONOLOGIST'S CARE AND IS TO HAVE A LUNG SCAN FOR FOLLOW-UP CARE. HE REMAINS ASYMPTOMATIC. THE PATIENT WILL SEE THE NEUROSURGEON FOR ANOTHER TRUFILL DCS COIL INSERTION IN COUPLE OF WEEKS. THE CASE WAS A RIGHT THALAMIC AVM WITH DRAINAGE IN A DILATED VEIN OF GALEN. IT WAS REPORTED BY THE PHYSICIAN THAT THE EVENT OF GLUE PULMONARY EMBOLIZATION PROBABLY HAPPENED ON THE FIRST INJECTION OF NBCA (25 %: 1.2 CC). IT WAS A FEEDER ARISING FROM THE POSTERO LATERAL CHOROIDAL BRANCH. IT WAS NOT A LARGE AND HAD A SMALL NETWORK INTERPOSE BEFORE VENOUS DRAINAGE AND ALSO IT DID NOT APPEAR EXTREMELY HIGH FLOW. THE FIRST PART OF THE NBCA DEPOSITION SUDDENLY BROKE LOOSE FROM THE MICROCATHETER AND MIGRATED VERY FAST THROUGH THE DRAINING VEIN PASSING THROUGH THE DURAL SINUSES. THEN, INJECTION WAS HALTED FOR A FEW SECONDS AND THE INJECTION WAS RESTARTED COMPLETING THE CASTING OF THE PEDICLE WITH SOME ADDITIONAL NBCA. THE CATHETER WAS PULLED WITHOUT PROBLEMS. A FEW MINUTES AFTER THERE WAS A BRIEF COUGH RESPONSE FROM THE PATIENT. DURING THIS PROCEDURE THERE WERE TWO ADDITIONAL UNEVENTFUL GLUE DEPOSITIONS. THE PATIENT IS NEUROLOGICALLY INTACT. IT WAS REPORTED BY THE PHYSICIAN THAT THERE ARE NO RESPIRATORY OR CARDIOVASCULAR ISSUES NOTED. THE PATIENT WAS DISCHARGED TWO DAYS AFTER PROCEDURE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.