Description of Event or Problem · 1
ACUTE PANCREATITIS,, REFLUX OF THE EMBOLIC BEADS INTO THE GDA [DEVICE DEPLOYMENT ISSUE], BEADS LOADED WITH 50 MG DOXORUBICIN AND LIPIODOL [OFF LABEL USE OF DEVICE]. CASE DESCRIPTION: INFORMATION RECEIVED ON 31-MAR-2017: THIS MEDICAL DEVICE REPORT WAS RECEIVED FROM A LITERATURE ARTICLE BY KHRISHNAMUTHY P., ET AL. ENTITLED "ACUTE PANCREATITIS AS A COMPLICATION OF TRANS-ARTERIAL CHEMOEMBOLIZATION OF HEPATOCELLULAR CANCER-CASE REPORT AND REVIEW OF LITERATURE" PUBLISHED IN THE JOURNAL OF GASTROINTESTINAL ONCOLOGY REGARDING A (B)(6) MALE PATIENT. THE PATIENT'S MEDICAL HISTORY INCLUDED CHRONIC (B)(6), CIRRHOSIS AND MULTIFOCAL HEPATOCELLULAR CARCINOMA (HCC) WITH A DOMINANT LESION IN THE MEDIAL LEFT LOBE OF THE LIVER. AORTOGRAM, SUPERIOR MESENTERIC ARTERIOGRAM AND CELIAC ARTERY (CA) INJECTIONS WERE PERFORMED. CELIAC ARTERIOGRAM AND SUBSEQUENT SELECTIVE ARTERIOGRAM OF THE COMMON HEPATIC ARTERY (CHA) SHOWED VARIANT ARTERIAL ANATOMY WITH THE MIDDLE HEPATIC ARTERY (MHA) ARISING DIRECTLY FROM THE GASTRODUODENAL ARTERY (GDA) IN CLOSE PROXIMITY TO THE ORIGIN OF THE SUPERIOR PANCREATIC ARTERY. THE PATIENT'S PAST DRUG HISTORY WAS NOT REPORTED. HOWEVER, DURING THE IMMEDIATE PRE AND POST PROCEDURE PERIOD THE PATIENT WAS ADMINISTERED WITH CEFAZOLIN AND METRONIDAZOLE FOR PROPHYLAXIS. ON AN UNKNOWN DATE A TRANSARTERIAL CHEMOEMBOLIZATION (TACE) WAS PERFORMED VIA THE RIGHT TRANS-FEMORAL APPROACH. SUPER SELECTIVE CATHETERIZATION OF THE MHA (SUPPLYING THE MEDIAL SEGMENT OF LEFT HEPATIC LOBE) WAS PERFORMED AND THIS WAS FOUND TO BE SUPPLYING THE SUSPECTED LESION. ON AN UNKNOWN DATE, THE PATIENT WAS TREATED WITH 70-150 MICRONS LC BEAD M1 (LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED) LOADED WITH 50 MG OF DOXORUBICIN AND LIPIODOL, FOR MULTIFOCAL HCC. SUBSEQUENTLY, THE LATERAL SEGMENT OF LEFT THE LATERAL SEGMENT OF LEFT HEPATIC ARTERY AND THE RIGHT HEPATIC ARTERY WERE ALSO EMBOLIZED USING 100-300 MICRONS BEADS LOADED WITH 50 MG OF DOXORUBICIN ALONG WITH 3 ML OF LIPIODOL. ON AN UNKNOWN DATE, WITHIN 24 HOURS OF TACE PROCEDURE, THE PATIENT DEVELOPED SIGNIFICANT EPIGASTRIC PAIN. HIS COMPLETE BLOOD COUNT SHOWED AN ELEVATED WHITE BLOOD CELLS (WBC) COUNT OF 15.4 T/C MM. SERUM AMYLASE AND LIPASE LEVELS WERE 400 (REF: 28-100) AND 3809 (REF: 73-383) U/L RESPECTIVELY. HIS LIVER FUNCTION TESTS SHOWED MODERATE ELEVATION OF SERUM ASPARTATE AMINOTRANSFERASE (AST) AND ALANINE AMINOTRANSFERASE (ALT) AT 314 (REF: 9-14) AND 168 (REF: 17-63) IU/L RESPECTIVELY. SERUM ALKALINE PHOSPHATASE AND TOTAL BILIRUBIN WERE NORMAL. HIS RIGHT UPPER QUADRANT ULTRASOUND DID NOT SHOW GALLSTONES OR BILIARY DILATION. 24 HOURS POST TACE, THE COMPUTER TOMOGRAPHY SCAN OF THE ABDOMEN PERFORMED WITHOUT CONTRAST SHOWED NEW FINDING OF ENLARGED HEAD OF THE PANCREAS WITH PERI-PANCREATIC FAT STRANDING CONSISTENT WITH ACUTE PANCREATITIS. A DIAGNOSIS OF TACE INDUCED ACUTE PANCREATITIS WAS MADE AND PATIENT WAS TREATED CONSERVATIVELY. THE PATIENT COURSE OF HOSPITALIZATION WAS UNEVENTFUL AND HE WAS DISCHARGED 72 HOURS LATER, IN A STABLE CONDITION. HE APPEARED WELL 4 WEEKS AFTER DISCHARGE, WITHOUT FURTHER COMPLICATIONS. HE WAS SUBSEQUENTLY TREATED AGAIN 5 MONTHS LATER TO THE SAME ARTERY WITH THE SAME REAGENTS BUT UTILIZING A SPECIAL MICRO CATHETER DESIGNED TO ACT AS A ONE WAY VALVE DURING BEAD DELIVERY TO PREVENT REFLUX. THE PATIENT TOLERATED THIS PROCEDURE WELL AND WAS DISCHARGED THE NEXT DAY WITHOUT ANY SIGNS OF COMPLICATION. THE REPORTING AUTHOR DID NOT ASSESS THE SERIOUSNESS OF THE EVENTS TO LC BEAD M1. HOWEVER, THE REPORTING AUTHOR CONSIDERED ACUTE PANCREATITIS A COMPLICATION OF THE TACE PROCEDURE. EVEN THOUGH, A SUPER SELECTIVE CATHETERIZATION OF THE MHA SUPPLYING THE TUMOR IN THE MEDIAL LEFT LOBE WAS ACHIEVED, THE ANATOMICAL VARIATION OF THIS ARTERY ARISING DIRECTLY FROM THE GDA, INSTEAD OF FROM THE PROPER HEPATIC ARTERY, MAY HAVE RESULTED IN REFLUX OF THE EMBOLIC BEADS INTO THE GDA AND ACUTE PANCREATITIS. THE COMPANY CONSIDERED THE EVENTS ACUTE PANCREATITIS AND REFLUX OF THE EMBOLIC BEADS INTO THE GDA SERIOUS (MEDICALLY SIGNIFICANT). BTG WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL INFORMATION IS RECEIVED. COMPANY COMMENTS: PANCREATITIS ACUTE AND DEVICE DEPLOYMENT ISSUE ARE CONSIDERED ANTICIPATED ACCORDING TO THE LC BEAD M1 CURRENT REFERENCE SAFETY INFORMATION WHEREAS OFF LABEL USE OF DEVICE IS UNANTICIPATED. IN AGREEMENT WITH THE PHYSICIAN, THE COMPANY CONSIDERED PANCREATITIS ACUTE AND DEVICE DEPLOYMENT ISSUE AS RELATED TO LC BEAD M1 THERAPY. OFF LABEL USE OF DEVICE IS CONSIDERED A SPECIAL SCENARIO AND AS THEREFORE NOT ASSESSABLE AS AN ADVERSE EVENT. THERE WAS NO REPORT OF DEVICE DEFICIENCY OR MALFUNCTION.