LC BEAD
Report
- Report Number
- 3002124545-2016-00015
- Event Type
- Death
- Date Received
- February 26, 2016
- Report Date
- February 10, 2016
- Manufacturer
- BIOCOMPATIBLES UK LTD
- Product Code
- HCG
- PMA / PMN Number
- K094018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
HEPATIC FAILURE [HEPATIC FAILURE]. POSTEMBOLIZATION SYNDROME CONSISTING OF PAIN FEVER, AND/OR NAUSEA AND VOMITING [POST EMBOLISATION SYNDROME]. ELEVATION IN ALT IMMEDIATELY POSTEMBOLIZATION [ALANINE AMINOTRANSFERASE INCREASED]. ELEVATION IN AST IMMEDIATELY POSTEMBOLIZATION [ASPARTATE AMINOTRANSFERASE INCREASED]. ELEVATION IN BILIRUBIN IMMEDIATELY POSTEMBOLIZATION [BLOOD BILIRUBIN INCREASED]. PANCREATITIS [PANCREATITIS]. DEEP VEIN THROMBOSIS [DEEP VEIN THROMBOSIS]. PULMONARY EMBOLUS [PULMONARY EMBOLISM]. CASE DESCRIPTION: THIS LITERATURE MEDICAL DEVICE REPORT WAS PUBLISHED IN JOURNAL OF CLINICAL ONCOLOGY BY BROWN K ET AL, ENTITLED "RANDOMIZED TRIAL OF HEPATIC ARTERY EMBOLIZATION FOR HEPATOCELLULAR CARCINOMA USING DOXORUBICIN-ELUTING MICROSPHERES COMPARED WITH EMBOLIZATION WITH MICROSPHERES ALONE" CONCERNING AN UNSPECIFIED NUMBER OF PATIENTS WHO WERE EMBOLIZED WITH LC BEAD (AGES AND GENDERS UNKNOWN). THE SUBJECTS' MEDICAL HISTORY INCLUDED BEING OLDER THAN 18 YEARS WITH A DIAGNOSIS OF HEPATOCELLULAR CARCINOMA (HCC), WITH EASTERN COOPERATIVE ONCOLOGY GROUP-PERFORMANCE SCORES OF 0-1 AND OKUDA STAGE I AND II WERE ELIGIBLE. ADEQUATE ORGAN FUNCTION, INCLUDING CREATININE LESS THAN 2X THE UPPER LIMIT OF NORMAL AND BILIRUBIN LESS THAN 3.0 MG/DL, WAS REQUIRED. PORTAL VEIN INVASION AT ANY LEVEL WAS ALLOWED AS LONG AS LIVER FUNCTION WAS PRESERVED. PATIENTS COULD HAVE LIMITED EXTRAHEPATIC DISEASE, SUCH AS A FEW SMALL LUNG NODULES OR ENLARGED REGIONAL LYMPH NODES, AT ENROLLMENT. CONCOMITANT MEDICATIONS INCLUDED HYDRATION WITH NORMAL SALINE, AN ANTIEMETIC (PALONOSETRON HYDROCHLORIDE 0.25 MG IV) AND ANTIBIOTIC (CEPHAZOLIN 1G IV). THE EMBOLIZATION PROCEDURES WERE PERFORMED USING CONSCIOUS SEDATION OR GENERAL ANESTHESIA. BETWEEN DEC-2007 AND APR-2012, 92 PATIENTS UNDERWENT 129 EMBOLIZATION PROCEDURES TO COMPLETE THEIR INITIAL TREATMENT, WITH A TOTAL OF 209 EMBOLIZATIONS DURING THE ENTIRE STUDY. THE PATIENTS UNDERWENT A MEDIAN OF TWO EMBOLIZATIONS, AND THE AVERAGE HOSPITAL STAY WAS 3.5 DAYS PER PATIENT IN EACH GROUP. OF THESE 92 PATIENTS, FORTY EIGHT PATIENTS (48) RECEIVED LC BEAD LOADED WITH DOXORUBICIN. DOXORUBICIN 150 MG WAS LOADED ONTO EITHER 4 OR 6 ML OF LCB MICROSPHERES (37.5 OR 50 MGLML), DEPENDING ON ASSESSMENT OF A COMBINATION OF TUMOR VOLUME AND VASCULARITY. IF ONE TARGET VESSEL WAS IDENTIFIED, THE PATIENT RECEIVED 100-300 MICROM. IF MORE THAN ONE TARGET VESSEL WAS IDENTIFIED, THE LC BEADS 100-300 MICROM ARE DIVIDED PROPORTIONALLY. IF STASIS DID NOT OCCUR IN EITHER GROUP, THE PATIENT RECEIVED BEAD BLOCK 100-300 MICROM LESS THAN OR EQUAL TO 10 CC. IF STASIS DID NOT OCCUR IN EITHER GROUP, THE PATIENT RECEIVED BEAD BLOCK 300-500 MICROM, LESS THAN OR EQUAL TO 10 CC IF STASIS DID NOT OCCUR IN EITHER GROUP, THE PATIENT RECEIVED BEAD BLOCK 500-700 MICROM, LESS THAN OR EQUAL TO 10 CC. IF STASIS DID NOT OCCUR IN EITHER GROUP, THEN THE PATIENT COMPLETED EMBOLIZATION WITH 100 MICROM POLYVINYL ALCOHOL (PVA). STASIS WAS DEFINED AS THE ABSENCE OF ANTEGRADE FLOW WITHIN A VESSEL SUCH THAT CONTRAST FILLING THE TARGET VESSEL PERSISTED, WITHOUT WASHOUT, FIVE CARDIAC BEATS AFTER THE INJECTION OF CONTRAST. ON AN UNKNOWN DATE, A PATIENT WHO WAS EMBOLIZED WITH LC BEAD DEVELOPED LIVER FAILURE AND DIED 25 DAYS POST-EMBOLIZATION. THE OUTCOME OF THE LIVER FAILURE WAS FATAL. ON AN UNKNOWN DATE, APPROXIMATELY 40 PATIENTS NOTED AS 84% OF PATIENTS WHO WERE EMBOLIZED WITH LC BEAD EXPERIENCED POSTEMBOLIZATION SYNDROME CONSISTING OF PAIN, FEVER, AND/OR NAUSEA AND VOMITING WHICH WAS NOTED AS COMMON AND OCCURRING AFTER THE FIRST TREATMENT CYCLE. THE OUTCOMES OF THESE EVENTS ARE UNKNOWN. ON AN UNKNOWN DATE, AN UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED 71 SERIOUS ADVERSE EVENTS (SAES) MOST COMMONLY ELEVATION IN ALT, AST OR BILIRUBIN IMMEDIATELY POST EMBOLIZATION. FORTY NINE (49) WERE GRADE 3 SAES, 21 WERE GRADE 4 SAES, AND 1 WAS A GRADE 5 SAE. THE OUTCOMES OF THESE EVENTS ARE UNKNOWN. ON AN UNKNOWN DATE, A PATIENT WHO WAS EMBOLIZED WITH LC BEAD DEVELOPED PANCREATITIS WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE PANCREATITIS WAS UNKNOWN. ON AN UNKNOWN DATE, A PATIENT WHO WAS EMBOLIZED WITH LC BEAD DEVELOPED A DEEP VEIN THROMBOSIS WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE DEEP VEIN THROMBOSIS WAS UNKNOWN. ON UNKNOWN DATES, 4 PATIENTS EXPERIENCED A PULMONARY EMBOLUS (PE) WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOMES OF THE EVENTS ARE UNKNOWN. THE AUTHORS DID NOT PROVIDE THE RELATIONSHIP OF THE EVENT LIVER FAILURE TO THE USE OF LC BEAD. THE AUTHORS DID NOT PROVIDE AN ASSESSMENT THE SEVERITY OF THE POSTEMBOLIZATION SYNDROME CONSISTING OF PAIN, FEVER, AND/OR NAUSEA AND VOMITING BUT RELATED THE EVENTS TO THE EMBOLIZATION PROCEDURE. THE AUTHORS CONSIDERED THE EVENTS OF ELEVATION IN ALT, AST OR BILIRUBIN IMMEDIATELY POSTEMBOLIZATION AS SERIOUS ADVERSE EVENTS AND WERE RELATED TO LC BEAD. THE AUTHORS CONSIDERED THE EVENTS OF PANCREATITIS, DVT, AND PE TO BE MAJOR COMPLICATIONS, ACCORDING TO SOCIETY OF INTERVENTIONAL RADIOLOGY REPORTING STANDARDS BUT DID NOT PROVIDE THEIR RELATIONSHIP TO LC BEAD. THE COMPANY ASSESSED: THE EVENT OF LIVER FAILURE AS SERIOUS (FATAL); POSTEMBOLIZATION SYNDROME AS SERIOUS (MEDICALLY SIGNIFICANT); THE EVENTS OF ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED AND BLOOD BILIRUBIN INCREASED AS SERIOUS (MEDICALLY SIGNIFICANT); THE EVENT OF PANCREATITIS AS SERIOUS (MEDICALLY SIGNIFICANT); THE EVENT OF DVT AS SERIOUS (MEDICALLY SIGNIFICANT) AND THE EVENTS OF PE AS SERIOUS (MEDICALLY SIGNIFICANT). FOLLOW-UP INFORMATION IS BEING REQUESTED. FOLLOW-UP INFORMATION WAS RECEIVED ON 08-MAR-2016: THE AUTHOR STATED THAT, AT THE TIME OF THE STUDY, THEY NOTIFIED THE FDA AND THEIR LOCAL IRB OF THE ADVERSE EVENTS THAT WERE DOCUMENTED IN THE ARTICLE. THIS CASE REPORT IS CONSIDERED TO BE FINAL. NO FURTHER INFORMATION IS EXPECTED. THE AUTHORS DID NOT PROVIDE THE RELATIONSHIP OF THE EVENT LIVER FAILURE TO THE USE OF LC BEAD. THE AUTHORS DID NOT PROVIDE AN ASSESSMENT THE SEVERITY OF THE POSTEMBOLIZATION SYNDROME CONSISTING OF PAIN, FEVER, AND/OR NAUSEA AND VOMITING BUT RELATED THE EVENTS TO THE EMBOLIZATION PROCEDURE. THE AUTHORS CONSIDERED THE EVENTS OF ELEVATION IN ALT, AST OR BILIRUBIN IMMEDIATELY POSTEMBOLIZATION AS SERIOUS ADVERSE EVENTS AND WERE RELATED TO LC BEAD. THE AUTHORS CONSIDERED THE EVENTS OF PANCREATITIS, DVT, AND PE TO BE MAJOR COMPLICATIONS, ACCORDING TO SOCIETY OF INTERVENTIONAL RADIOLOGY REPORTING STANDARDS BUT DID NOT PROVIDE THEIR RELATIONSHIP TO LC BEAD. THE COMPANY ASSESSED: THE EVENT OF LIVER FAILURE AS SERIOUS (FATAL); POSTEMBOLIZATION SYNDROME AS SERIOUS (MEDICALLY SIGNIFICANT); THE EVENTS OF ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED AND BLOOD BILIRUBIN INCREASED AS SERIOUS (MEDICALLY SIGNIFICANT); THE EVENT OF PANCREATITIS AS SERIOUS (MEDICALLY SIGNIFICANT); THE EVENT OF DVT AS SERIOUS (MEDICALLY SIGNIFICANT) AND THE EVENTS OF PE AS SERIOUS (MEDICALLY SIGNIFICANT). CASE COMMENTS: THE EVENTS OF LIVER FAILURE, POSTEMBOLIZATION SYNDROME, ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED, BLOOD BILIRUBIN INCREASED PANCREATITIS AND DEEP VEIN THROMBOSIS ARE CONSIDERED UNLISTED WHEREAS THE EVENT OF PULMONARY EMBOLUS IS CONSIDERED LISTED ACCORDING TO THE LC BEAD CURRENT REFERENCE SAFETY INFORMATION. IN THE ABSENCE OF AN ASSESSMENT BY THE AUTHORS; THE COMPANY CONSIDERS THE FATAL LIVER FAILURE AS RELATED TO LC BEAD DUE TO THE TEMPORAL RELATIONSHIP AS THE EVENT OCCURRED WITHIN 25 DAYS OF TREATMENT; THE COMPANY CONSIDERS PANCREATITIS, DEEP VEIN THROMBOSIS AND PULMONARY EMBOLUS TO BE RELATED TO THE USE OF LC BEAD DUE TO THE POSSIBLE TEMPORAL RELATIONSHIP. IN LINE WITH THE AUTHORS' ASSESSMENT, THE COMPANY CONSIDERS POSTEMBOLIZATION SYNDROME AS RELATED TO THE USE OF LC BEAD. IN AGREEMENT WITH THE AUTHORS, THE COMPANY CONSIDERS THE EVENTS ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED, AND BLOOD BILIRUBIN INCREASED TO BE RELATED TO LC BEAD DUE TO THE TEMPORAL RELATIONSHIP. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF LC BEAD. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED AND, BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS.
HEPATIC FAILURE [HEPATIC FAILURE]. POSTEMBOLIZATION SYNDROME CONSISTING OF PAIN FEVER, AND/OR NAUSEA AND VOMITING [POST EMBOLISATION SYNDROME]. ELEVATION IN ALT IMMEDIATELY POSTEMBOLIZATION [ALANINE AMINOTRANSFERASE INCREASED]. ELEVATION IN AST IMMEDIATELY POSTEMBOLIZATION [ASPARTATE AMINOTRANSFERASE INCREASED]. ELEVATION IN BILIRUBIN IMMEDIATELY POSTEMBOLIZATION [BLOOD BILIRUBIN INCREASED] PANCREATITIS [PANCREATITIS]. DEEP VEIN THROMBOSIS [DEEP VEIN THROMBOSIS]. PULMONARY EMBOLUS [PULMONARY EMBOLISM]. CASE DESCRIPTION: THIS LITERATURE MEDICAL DEVICE REPORT WAS PUBLISHED IN JOURNAL OF CLINICAL ONCOLOGY BY BROWN K ET AL, ENTITLED "RANDOMIZED TRIAL OF HEPATIC ARTERY EMBOLIZATION FOR HEPATOCELLULAR CARCINOMA USING DOXORUBICIN-ELUTING MICROSPHERES COMPARED WITH EMBOLIZATION WITH MICROSPHERES ALONE" CONCERNING AN UNSPECIFIED NUMBER OF PATIENTS WHO WERE EMBOLIZED WITH LC BEAD (AGES AND GENDERS UNKNOWN). THE SUBJECTS' MEDICAL HISTORY INCLUDED BEING OLDER THAN 18 YEARS WITH A DIAGNOSIS OF HEPATOCELLULAR CARCINOMA (HCC), WITH EASTERN COOPERATIVE ONCOLOGY GROUP-PERFORMANCE SCORES OF 0-1 AND OKUDA STAGE I AND II WERE ELIGIBLE. ADEQUATE ORGAN FUNCTION, INCLUDING CREATININE LESS THAN 2X THE UPPER LIMIT OF NORMAL AND BILIRUBIN LESS THAN 3.0 MG/DL, WAS REQUIRED. PORTAL VEIN INVASION AT ANY LEVEL WAS ALLOWED AS LONG AS LIVER FUNCTION WAS PRESERVED. PATIENTS COULD HAVE LIMITED EXTRAHEPATIC DISEASE, SUCH AS A FEW SMALL LUNG NODULES OR ENLARGED REGIONAL LYMPH NODES, AT ENROLLMENT. CONCOMITANT MEDICATIONS INCLUDED HYDRATION WITH NORMAL SALINE, AN ANTIEMETIC (PALONOSETRON HYDROCHLORIDE 0.25 MG IV) AND ANTIBIOTIC (CEPHAZOLIN 1G IV). THE EMBOLIZATION PROCEDURES WERE PERFORMED USING CONSCIOUS SEDATION OR GENERAL ANESTHESIA. BETWEEN DEC-2007 AND APR-2012, 92 PATIENTS UNDERWENT 129 EMBOLIZATION PROCEDURES TO COMPLETE THEIR INITIAL TREATMENT, WITH A TOTAL OF 209 EMBOLIZATIONS DURING THE ENTIRE STUDY. THE PATIENTS UNDERWENT A MEDIAN OF TWO EMBOLIZATIONS, AND THE AVERAGE HOSPITAL STAY WAS 3.5 DAYS PER PATIENT IN EACH GROUP. OF THESE 92 PATIENTS, FORTY EIGHT PATIENTS (48) RECEIVED LC BEAD LOADED WITH DOXORUBICIN. DOXORUBICIN 150 MG WAS LOADED ONTO EITHER 4 OR 6 ML OF LCB MICROSPHERES (37.5 OR 50 MGLML), DEPENDING ON ASSESSMENT OF A COMBINATION OF TUMOR VOLUME AND VASCULARITY. IF ONE TARGET VESSEL WAS IDENTIFIED, THE PATIENT RECEIVED 100-300 MICROM. IF MORE THAN ONE TARGET VESSEL WAS IDENTIFIED, THE LC BEADS 100-300 MICROM ARE DIVIDED PROPORTIONALLY. IF STASIS DID NOT OCCUR IN EITHER GROUP, THE PATIENT RECEIVED BEAD BLOCK 100-300 MICROM LESS THAN OR EQUAL TO 10 CC. IF STASIS DID NOT OCCUR IN EITHER GROUP, THE PATIENT RECEIVED BEAD BLOCK 300-500 MICROM, LESS THAN OR EQUAL TO 10 CC IF STASIS DID NOT OCCUR IN EITHER GROUP, THE PATIENT RECEIVED BEAD BLOCK 500-700 MICROM, LESS THAN OR EQUAL TO 10 CC. IF STASIS DID NOT OCCUR IN EITHER GROUP, THEN THE PATIENT COMPLETED EMBOLIZATION WITH 100 MICROM POLYVINYL ALCOHOL (PVA). STASIS WAS DEFINED AS THE ABSENCE OF ANTEGRADE FLOW WITHIN A VESSEL SUCH THAT CONTRAST FILLING THE TARGET VESSEL PERSISTED, WITHOUT WASHOUT, FIVE CARDIAC BEATS AFTER THE INJECTION OF CONTRAST. ON AN UNKNOWN DATE, A PATIENT WHO WAS EMBOLIZED WITH LC BEAD DEVELOPED LIVER FAILURE AND DIED 25 DAYS POST-EMBOLIZATION. THE OUTCOME OF THE LIVER FAILURE WAS FATAL. ON AN UNKNOWN DATE, APPROXIMATELY 40 PATIENTS NOTED AS 84% OF PATIENTS WHO WERE EMBOLIZED WITH LC BEAD EXPERIENCED POSTEMBOLIZATION SYNDROME CONSISTING OF PAIN, FEVER, AND/OR NAUSEA AND VOMITING WHICH WAS NOTED AS COMMON AND OCCURRING AFTER THE FIRST TREATMENT CYCLE. THE OUTCOMES OF THESE EVENTS ARE UNKNOWN. ON AN UNKNOWN DATE, AN UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED 71 SERIOUS ADVERSE EVENTS (SAES) MOST COMMONLY ELEVATION IN ALT, AST OR BILIRUBIN IMMEDIATELY POST EMBOLIZATION. FORTY NINE (49) WERE GRADE 3 SAES, 21 WERE GRADE 4 SAES, AND 1 WAS A GRADE 5 SAE. THE OUTCOMES OF THESE EVENTS ARE UNKNOWN. ON AN UNKNOWN DATE, A PATIENT WHO WAS EMBOLIZED WITH LC BEAD DEVELOPED PANCREATITIS WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE PANCREATITIS WAS UNKNOWN. ON AN UNKNOWN DATE, A PATIENT WHO WAS EMBOLIZED WITH LC BEAD DEVELOPED A DEEP VEIN THROMBOSIS WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE DEEP VEIN THROMBOSIS WAS UNKNOWN. ON UNKNOWN DATES, 4 PATIENTS EXPERIENCED A PULMONARY EMBOLUS (PE) WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOMES OF THE EVENTS ARE UNKNOWN. THE AUTHORS DID NOT PROVIDE THE RELATIONSHIP OF THE EVENT LIVER FAILURE TO THE USE OF LC BEAD. THE AUTHORS DID NOT PROVIDE AN ASSESSMENT THE SEVERITY OF THE POSTEMBOLIZATION SYNDROME CONSISTING OF PAIN, FEVER, AND/OR NAUSEA AND VOMITING BUT RELATED THE EVENTS TO THE EMBOLIZATION PROCEDURE. THE AUTHORS CONSIDERED THE EVENTS OF ELEVATION IN ALT, AST OR BILIRUBIN IMMEDIATELY POSTEMBOLIZATION AS SERIOUS ADVERSE EVENTS AND WERE RELATED TO LC BEAD. THE AUTHORS CONSIDERED THE EVENTS OF PANCREATITIS, DVT, AND PE TO BE MAJOR COMPLICATIONS, ACCORDING TO SOCIETY OF INTERVENTIONAL RADIOLOGY REPORTING STANDARDS BUT DID NOT PROVIDE THEIR RELATIONSHIP TO LC BEAD. THE COMPANY ASSESSED: THE EVENT OF LIVER FAILURE AS SERIOUS (FATAL); POSTEMBOLIZATION SYNDROME AS SERIOUS (MEDICALLY SIGNIFICANT); THE EVENTS OF ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED AND BLOOD BILIRUBIN INCREASED AS SERIOUS (MEDICALLY SIGNIFICANT); THE EVENT OF PANCREATITIS AS SERIOUS (MEDICALLY SIGNIFICANT); THE EVENT OF DVT AS SERIOUS (MEDICALLY SIGNIFICANT) AND THE EVENTS OF PE AS SERIOUS (MEDICALLY SIGNIFICANT). FOLLOW-UP INFORMATION IS BEING REQUESTED. CASE COMMENTS: THE EVENTS OF LIVER FAILURE, POSTEMBOLIZATION SYNDROME, ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED, BLOOD BILIRUBIN INCREASED PANCREATITIS AND DEEP VEIN THROMBOSIS ARE CONSIDERED UNLISTED WHEREAS THE EVENT OF PULMONARY EMBOLUS IS CONSIDERED LISTED ACCORDING TO THE LC BEAD CURRENT REFERENCE SAFETY INFORMATION. IN THE ABSENCE OF AN ASSESSMENT BY THE AUTHORS; THE COMPANY CONSIDERS THE FATAL LIVER FAILURE AS RELATED TO LC BEAD DUE TO THE TEMPORAL RELATIONSHIP AS THE EVENT OCCURRED WITHIN 25 DAYS OF TREATMENT; THE COMPANY CONSIDERS PANCREATITIS, DEEP VEIN THROMBOSIS AND PULMONARY EMBOLUS TO BE RELATED TO THE USE OF LC BEAD DUE TO THE POSSIBLE TEMPORAL RELATIONSHIP. IN LINE WITH THE AUTHORS' ASSESSMENT, THE COMPANY CONSIDERS POSTEMBOLIZATION SYNDROME AS RELATED TO THE USE OF LC BEAD. IN AGREEMENT WITH THE AUTHORS, THE COMPANY CONSIDERS THE EVENTS ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED, AND BLOOD BILIRUBIN INCREASED TO BE RELATED TO LC BEAD DUE TO THE TEMPORAL RELATIONSHIP. SINCE MOST (BUT NOT ALL) OF THE EVENTS ARE REPORTABLE, THIS REPORT IS CONSIDERED MEDICALLY REPORTABLE. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF LC BEAD. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED AND, BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 120785 | LC BEAD | HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE | HCG | BIOCOMPATIBLES UK LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| O | CEPHAZOLINE SODIUM (CEPHAZOLINE SODIUM) |