TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM

Report

Report Number: 1226348-2017-00065
Event Type: Injury
Date Received: June 1, 2017
Date of Event: January 1, 2014
Report Date: May 10, 2017
Manufacturer: CODMAN AND SHURTLEFF, INC
Product Code: KGG
PMA / PMN Number: P990040
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS IS INITIAL/FINAL MDR REPORT FOR THIS COMPLAINT. CONCOMITANT MEDICAL PRODUCTS: 6F ENVOY CATHETER (CODMAN NEUROVASCULAR, (B)(4)); MARATHON FLOW-DIRECTED MICROCATHETER (EV3 NEUROVASCULAR, (B)(4)); SYNCHRO-10 MICROWIRE (STRYKER NEUROVASCULAR, (B)(4)). LITERATURE ARTICLE ¿THE USE OF ADENOSINE IN THE TREATMENT OF A HIGH-FLOW VEIN OF GALEN MALFORMATION IN AN ADULT¿ BY MEI LYN ASTERIOS TSIMPAS, NOHRA CHALOUHI, JONATHAN D. HALEVY, STAVROPOULA TJOUMAKARIS, L. FERNANDO GONZALEZ, STEPHEN J. MONTEITH, AARON S. DUMONT, ROBERT ROSENWASSER, PASCAL JABBOUR, PUBLISHED JOURNAL OF CLINICAL NEUROSCIENCE 21 (2014) 1259¿1261 NO STERILE LOT NUMBER INFORMATION HAS BEEN AVAILABLE AND THE PRODUCT REMAINS IMPLANTED, THUS NO DHR OR ANALYSIS CAN BE PERFORMED. THROMBOSIS AND EMBOLISM ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE NBCA GLUE PRODUCT AND ARE LISTED IN THE IFU AS SUCH. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT LOCATION, SIZE AND HIGH ARTERIAL BLOOD FLOW MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER ACTIONS ARE NEEDED AT THIS TIME.

Description of Event or Problem · 1

IN THE LITERATURE ARTICLE ¿THE USE OF ADENOSINE IN THE TREATMENT OF A HIGH-FLOW VEIN OF GALEN MALFORMATION IN AN ADULT¿ BY MEI LYN ASTERIOS TSIMPAS, NOHRA CHALOUHI, JONATHAN D. HALEVY, STAVROPOULA TJOUMAKARIS, L. FERNANDO GONZALEZ, STEPHEN J. MONTEITH, AARON S. DUMONT, ROBERT ROSENWASSER, PASCAL JABBOUR, PUBLISHED JOURNAL OF CLINICAL NEUROSCIENCE 21 (2014) 1259¿1261, THE AUTHORS PRESENT TREATMENT OF HIGH-FLOW VEIN OF GALEN ANEURYSMAL MALFORMATIONS (VGAM) IN A PATIENT WITH USE OF ADENOSINE. A (B)(6) PATIENT PRESENTED WITH A HISTORY OF NON-SPECIFIC HEADACHES. HE HAD A HISTORY OF HEART FAILURE SINCE BIRTH THAT WAS CAUSED BY AN UNTREATED VGAM. HIS CARDIAC DISEASE WAS MANAGED CONSERVATIVELY WITH DIGOXIN AND BETA-BLOCKERS. HE WAS NEUROLOGICALLY INTACT ON PHYSICAL EXAMINATION. AN MRI/MAGNETIC RESONANCE ANGIOGRAPHY OF THE BRAIN AND A DIGITAL SUBTRACTION ANGIOGRAPHY SHOWED A COMPLEX, MURAL LESION WITH RAPID ARTERIOVENOUS (AV) SHUNTING. MULTIPLE ARTERIAL FEEDERS, WHICH ORIGINATED FROM ANTERIOR (ACA), MIDDLE AND POSTERIOR CEREBRAL ARTERIES BILATERALLY, AS WELL AS ANTERIOR AND POSTERIOR CHOROIDAL BRANCHES, TERMINATED AT A LARGELY DILATED VENOUS POUCH THAT DRAINED INTO A FALCINE SINUS. A 7 FRENCH (F) SHEATH WAS PLACED IN THE RIGHT COMMON FEMORAL ARTERY AND A 6F SHEATH WAS PLACED IN THE LEFT COMMON FEMORAL VEIN. THE BLOOD PRESSURE WAS MONITORED ADDITIONALLY VIA THE ARTERIAL GROIN SHEATH. A 6F ENVOY CATHETER (CODMAN NEUROVASCULAR, (B)(4)) WAS PLACED OVER A 0.038 INCH GUIDE WIRE INTO THE DISTAL CERVICAL SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). A MARATHON FLOW-DIRECTED MICROCATHETER (EV3 NEUROVASCULAR, (B)(4)) WAS ADVANCED OVER A SYNCHRO-10 MICROWIRE (STRYKER NEUROVASCULAR, (B)(4)) INTO THE DISTAL RIGHT ACA, JUST PROXIMAL TO ONE OF THE FISTULOUS POINTS. A MICROINJECTION WITH CONTRAST MADE OBVIOUS THAT EMBOLIZATION OF THE ARTERIAL FEEDER WITHOUT SLOWING DOWN THE AV SHUNT WOULD BE EXTREMELY DANGEROUS. A 70% MIXTURE OF N-BUTYLCYANOACRYLATE (TRUFILL N-BCA, CODMAN NEUROVASCULAR) IN ETHIODIZED OIL WAS CHOSEN DUE TO ITS ADHESIVE PROPERTIES AND RAPID POLYMERIZATION. A NICARDIPINE INFUSION DROPPED THE MEAN ARTERIAL PRESSURE TO 40. A REPEAT RIGHT ICA ANGIOGRAM DID NOT DEMONSTRATE ANY SIGNIFICANT SLOWING OF THE AV SHUNT. A SLOW INJECTION OF N-BCA WAS ATTEMPTED, BUT IT WAS RAPIDLY SHUNTED TO THE VENOUS SIDE. AN ATTEMPT TO FURTHER DECREASE THE FLOW WITH MULTIPLE COILS THROUGH THE VENOUS SIDE WITHOUT DETACHING THEM WAS UNSUCCESSFUL, SINCE THE STRONG AV SHUNT PUSHED THEM OUT OF THE VENOUS POUCH AND INTO THE TORCULA. THEY WERE PULLED OUT BEFORE BECOMING DETACHED. THE NICARDIPINE INFUSION WAS STOPPED. A TEST DOSE OF 21 MG ADENOSINE (0.3 MG/KG) PRODUCED ONLY A 3¿4 SECOND FLOW ARREST. A SUBSEQUENT DOSE OF 39 MG (0.55 MG/KG) PRODUCED AN APPROXIMATELY 10 SECOND LONG NEAR ASYSTOLE, AND THE N-BCA WAS INJECTED INTO THE RIGHT ACA FEEDER. A REPEAT ANGIOGRAPHIC RUN SHOWED SIGNIFICANT SLOWING OF THE AV SHUNT WITHOUT SUBSTANTIAL OBSTRUCTION OF THE VENOUS OUTFLOW. THE PATIENT WAS THEN EXTUBATED AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. HE WAS NEUROLOGICALLY INTACT. DURING THE FIRST POSTOPERATIVE NIGHT, THE PATIENT BECAME PROGRESSIVELY LETHARGIC AND STOPPED FOLLOWING COMMANDS. A CT SCAN OF THE BRAIN REVEALED CLOTTING OF THE VENOUS POUCH AND FORMATION OF A RIGHT BASAL GANGLIA AND A LEFT FRONTAL VENOUS INFARCTION WITH EARLY HEMORRHAGIC TRANSFORMATION. EMBOLIC MATERIAL WAS SEEN INSIDE THE FALCINE SINUS AND THE TORCULA, CAUSING AT LEAST PARTIAL OUTFLOW OBSTRUCTION. THE PATIENT WAS EVENTUALLY DISCHARGED TO A REHABILITATION FACILITY AND HIS CLINICAL CONDITION PROGRESSIVELY IMPROVED TO THE POINT WHERE HE WAS NEUROLOGICALLY INTACT AT HIS 6-MONTH CLINICAL FOLLOW-UP. FOLLOW-UP ANGIOGRAPHY ALSO DEMONSTRATED 100% OCCLUSION OF THE LESION. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
386528	TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM	TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS	KGG	CODMAN AND SHURTLEFF, INC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR		Required Intervention