BEAD BLOCK
Report
- Report Number
- 3002124545-2016-00014
- Event Type
- Death
- Date Received
- February 25, 2016
- Report Date
- February 10, 2016
- Manufacturer
- BIOCOMPATIBLES UK LTD
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEATH [DEATH]. POSTEMBOLIZATION SYNDROME CONSISTING OF PAIN, FEVER, AND/OR NAUSEA AND VOMITING [POST EMBOLIZATION SYNDROME] ELEVATION IN AST [ASPARTATE AMINOTRANSFERASE INCREASED]. ELEVATION IN ALT [ALANINE AMINOTRANSFERASE INCREASED]. ELEVATION IN BILIRUBIN IMMEDIATELY POSTEMBOLIZATION [BLOOD BILIRUBIN INCREASED]. CHOLECYSTITIS [CHOLECYSTITIS]. LIVER ABSCESS [LIVER ABSCESS]. LIVER FAILURE (TRANSIENT) [HEPATIC FAILURE]. PUNCTURE SITE COMPLICATION [PUNCTURE SITE REACTION]. PULMONARY EMBOLUS (PE) [PULMONARY EMBOLISM]. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON (B)(6) 2016: 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 BEAD BLOCK (AGE AND GENDER 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 SEVEN PATIENTS (47) RECEIVED BEAD BLOCK 100-300 MICROM LESS THAN OR EQUAL TO 10 CC. IF STASIS DID NOT OCCUR, THE PATIENT RECEIVED BEAD BLOCK 300-500 MICROM, LESS THAN OR EQUAL TO 10 CC. IF AGAIN STASIS DID NOT OCCUR, THE PATIENT RECEIVED BEAD BLOCK 500-700 MICROM, LESS THAN OR EQUAL TO 10 CC. IF STASIS DID NOT OCCUR AGAIN, THEN THE PATIENT RECEIVED BEAD BLOCK 700-900 MICROM, LESS THAN OR EQUAL TO 10 CC. IF STASIS DID NOT OCCUR AGAIN, THEN THE PATIENT COMPLETED EMBOLIZATION WITH 100 MICROM POLYVINYL ALCOHOL (PVA). ON AN UNKNOWN DATE, ONE PATIENT DIED UNEXPECTEDLY AT HOME TWO WEEKS AFTER THE FIRST EMBOLIZATION, BEFORE TREATMENT WAS COMPLETED. THE CAUSE OF DEATH WAS NOT PROVIDED. ON AN UNKNOWN DATE, APPROXIMATELY 41 PATIENTS, NOTED AS 88% OF PATIENTS WHO WERE EMBOLIZED WITH BEAD BLOCK, 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 THE EVENTS ARE UNKNOWN. ON AN UNKNOWN DATE, AN UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED 61 SERIOUS ADVERSE EVENTS (SAE) MOST COMMONLY ELEVATION IN ALT, AST OR BILIRUBIN IMMEDIATELY POSTEMBOLIZATION. THERE WERE 41 GRADE 3 SAES, 19 GRADE 4 SAES AND 1 GRADE 5 SAE. THE OUTCOMES OF THE EVENTS WERE UNKNOWN. ON AN UNKNOWN DATE, TWO PATIENTS EXPERIENCED CHOLECYSTITIS WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THESE EVENTS IS UNKNOWN. ON AN UNKNOWN DATE, ONE PATIENT EXPERIENCED A LIVER ABSCESS WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE EVENT IS UNKNOWN. ON AN UNKNOWN DATE, ONE PATIENT EXPERIENCED LIVER FAILURE (TRANSIENT) WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE EVENT IS UNKNOWN. ON AN UNKNOWN DATE, ONE PATIENT EXPERIENCED A PUNCTURE SITE REACTION WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE EVENT IS UNKNOWN. ON AN UNKNOWN DATE, ONE PATIENT EXPERIENCED A PULMONARY EMBOLUS WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE EVENT IS UNKNOWN. THE AUTHORS DID NOT PROVIDE AN ASSESSMENT OF THE EVENT OF DEATH IN RELATIONSHIP TO BEAD BLOCK. THE AUTHORS DID NOT PROVIDE AN ASSESSMENT OF THE EVENT OF POST EMBOLIZATION SYNDROME'S SEVERITY BUT RELATED THE EVENT TO THE EMBOLIZATION PROCEDURE. THE AUTHORS CONSIDERED THE EVENTS OF CHOLECYSTITIS, LIVER ABSCESS, LIVER FAILURE (TRANSIENT), PUNCTURE SITE COMPLICATION, AND PULMONARY EMBOLUS AS MAJOR COMPLICATIONS, ACCORDING TO SOCIETY OF INTERVENTIONAL RADIOLOGY REPORTING STANDARDS BUT DID NOT PROVIDE ITS RELATIONSHIP TO BEAD BLOCK. THE AUTHORS CONSIDERED THE EVENTS OF ELEVATION IN ALT, AST OR BILIRUBIN IMMEDIATELY POSTEMBOLIZATION AS SERIOUS ADVERSE EVENTS WHICH WERE RELATED TO BEAD BLOCK. THE COMPANY ASSESSED ALL OF THE EVENTS SERIOUS. FOLLOW-UP INFORMATION IS BEING REQUESTED. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 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 AN ASSESSMENT OF THE EVENT OF DEATH IN RELATIONSHIP TO BEAD BLOCK. THE AUTHORS DID NOT PROVIDE AN ASSESSMENT OF THE EVENT OF POST EMBOLIZATION SYNDROME'S SEVERITY BUT RELATED THE EVENT TO THE EMBOLIZATION PROCEDURE. THE AUTHORS CONSIDERED THE EVENTS OF CHOLECYSTITIS, LIVER ABSCESS, LIVER FAILURE (TRANSIENT), PUNCTURE SITE COMPLICATION, AND PULMONARY EMBOLUS AS MAJOR COMPLICATIONS, ACCORDING TO SOCIETY OF INTERVENTIONAL RADIOLOGY REPORTING STANDARDS BUT DID NOT PROVIDE ITS RELATIONSHIP TO BEAD BLOCK. THE AUTHORS CONSIDERED THE EVENTS OF ELEVATION IN ALT, AST OR BILIRUBIN IMMEDIATELY POSTEMBOLIZATION AS SERIOUS ADVERSE EVENTS WHICH WERE RELATED TO BEAD BLOCK. THE COMPANY ASSESSED ALL OF THE EVENTS SERIOUS. CASE COMMENTS: THE EVENTS OF DEATH AND PULMONARY EMBOLISM ARE LISTED ACCORDING TO THE BEAD BLOCK CURRENT REFERENCE SAFETY INFORMATION WHEREAS THE EVENTS OF ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED, BLOOD BILIRUBIN INCREASED, POSTEMBOLIZATION SYNDROME, CHOLECYSTITIS, LIVER ABSCESS, HEPATIC FAILURE, AND PUNCTURE SITE REACTION ARE CONSIDERED UNLISTED. IN ABSENCE OF THE AUTHORS' ASSESSMENT, THE COMPANY CONSIDERS THE EVENTS OF DEATH, CHOLECYSTITIS, LIVER ABSCESS, AND HEPATIC FAILURE AS RELATED DUE TO A POSSIBLE TEMPORAL RELATIONSHIP. IN AGREEMENT WITH THE AUTHORS' ASSESSMENT, THE COMPANY CONSIDERS THAT THE EVENTS OF ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED AND BLOOD BILIRUBIN INCREASED ARE RELATED TO THE USE OF BEAD BLOCK DUE TO THE TEMPORAL RELATIONSHIP. IN LINE WITH THE AUTHORS' ASSESSMENT, THE COMPANY CONSIDERS THAT POSTEMBOLIZATION SYNDROME AS NOT-RELATED TO THE USE OF BEAD BLOCK BUT RELATED TO THE EMBOLIZATION PROCEDURE. 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 BEAD BLOCK. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED AND, BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS.
DEATH [DEATH]. POSTEMBOLIZATION SYNDROME CONSISTING OF PAIN, FEVER, AND/OR NAUSEA AND VOMITING [POST EMBOLISATION SYNDROME]; ELEVATION IN AST [ASPARTATE AMINOTRANSFERASE INCREASED]; ELEVATION IN ALT [ALANINE AMINOTRANSFERASE INCREASED]; ELEVATION IN BILIRUBIN IMMEDIATELY POSTEMBOLIZATION [BLOOD BILIRUBIN INCREASED]; CHOLECYSTITIS [CHOLECYSTITIS]; LIVER ABSCESS [LIVER ABSCESS]; LIVER FAILURE (TRANSIENT) [HEPATIC FAILURE]; PUNCTURE SITE COMPLICATION [PUNCTURE SITE REACTION]; PULMONARY EMBOLUS (PE) [PULMONARY EMBOLISM]. CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 10-FEB-2016: 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 BEAD BLOCK (AGE AND GENDER 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 SEVEN PATIENTS (47) RECEIVED BEAD BLOCK 100-300 MICROM LESS THAN OR EQUAL TO 10 CC. IF STASIS DID NOT OCCUR, THE PATIENT RECEIVED BEAD BLOCK 300-500 MICROM, LESS THAN OR EQUAL TO 10 CC. IF AGAIN STASIS DID NOT OCCUR, THE PATIENT RECEIVED BEAD BLOCK 500-700 MICROM, LESS THAN OR EQUAL TO 10 CC. IF STASIS DID NOT OCCUR AGAIN, THEN THE PATIENT RECEIVED BEAD BLOCK 700-900 MICROM, LESS THAN OR EQUAL TO 10 CC. IF STASIS DID NOT OCCUR AGAIN, THEN THE PATIENT COMPLETED EMBOLIZATION WITH 100 MICROM POLYVINYL ALCOHOL (PVA). ON AN UNKNOWN DATE, ONE PATIENT DIED UNEXPECTEDLY AT HOME TWO WEEKS AFTER THE FIRST EMBOLIZATION, BEFORE TREATMENT WAS COMPLETED. THE CAUSE OF DEATH WAS NOT PROVIDED. ON AN UNKNOWN DATE, APPROXIMATELY 41 PATIENTS, NOTED AS 88% OF PATIENTS WHO WERE EMBOLIZED WITH BEAD BLOCK, 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 THE EVENTS ARE UNKNOWN. ON AN UNKNOWN DATE, AN UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED 61 SERIOUS ADVERSE EVENTS (SAE) MOST COMMONLY ELEVATION IN ALT, AST OR BILIRUBIN IMMEDIATELY POSTEMBOLIZATION. THERE WERE 41 GRADE 3 SAES, 19 GRADE 4 SAES AND 1 GRADE 5 SAE. THE OUTCOMES OF THE EVENTS WERE UNKNOWN. ON AN UNKNOWN DATE, TWO PATIENTS EXPERIENCED CHOLECYSTITIS WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THESE EVENTS IS UNKNOWN. ON AN UNKNOWN DATE, ONE PATIENT EXPERIENCED A LIVER ABSCESS WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE EVENT IS UNKNOWN. ON AN UNKNOWN DATE, ONE PATIENT EXPERIENCED LIVER FAILURE (TRANSIENT) WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE EVENT IS UNKNOWN. ON AN UNKNOWN DATE, ONE PATIENT EXPERIENCED A PUNCTURE SITE REACTION WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE EVENT IS UNKNOWN. ON AN UNKNOWN DATE, ONE PATIENT EXPERIENCED A PULMONARY EMBOLUS WITHIN 30 DAYS OF EMBOLIZATION. THE OUTCOME OF THE EVENT IS UNKNOWN. THE AUTHORS DID NOT PROVIDE AN ASSESSMENT OF THE EVENT OF DEATH IN RELATIONSHIP TO BEAD BLOCK. THE AUTHORS DID NOT PROVIDE AN ASSESSMENT OF THE EVENT OF POST EMBOLIZATION SYNDROME'S SEVERITY BUT RELATED THE EVENT TO THE EMBOLIZATION PROCEDURE. THE AUTHORS CONSIDERED THE EVENTS OF CHOLECYSTITIS, LIVER ABSCESS, LIVER FAILURE (TRANSIENT), PUNCTURE SITE COMPLICATION, AND PULMONARY EMBOLUS AS MAJOR COMPLICATIONS, ACCORDING TO SOCIETY OF INTERVENTIONAL RADIOLOGY REPORTING STANDARDS BUT DID NOT PROVIDE ITS RELATIONSHIP TO BEAD BLOCK. THE AUTHORS CONSIDERED THE EVENTS OF ELEVATION IN ALT, AST OR BILIRUBIN IMMEDIATELY POSTEMBOLIZATION AS SERIOUS ADVERSE EVENTS WHICH WERE RELATED TO BEAD BLOCK. THE COMPANY ASSESSED ALL OF THE EVENTS SERIOUS. FOLLOW-UP INFORMATION IS BEING REQUESTED. CASE COMMENTS: THE EVENTS OF DEATH AND PULMONARY EMBOLISM ARE LISTED ACCORDING TO THE BEAD BLOCK CURRENT REFERENCE SAFETY INFORMATION WHEREAS THE EVENTS OF ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED, BLOOD BILIRUBIN INCREASED, POSTEMBOLIZATION SYNDROME, CHOLECYSTITIS, LIVER ABSCESS, HEPATIC FAILURE, AND PUNCTURE SITE REACTION ARE CONSIDERED UNLISTED. IN ABSENCE OF THE AUTHORS' ASSESSMENT, THE COMPANY CONSIDERS THE EVENTS OF DEATH, CHOLECYSTITIS, LIVER ABSCESS, AND HEPATIC FAILURE AS RELATED DUE TO A POSSIBLE TEMPORAL RELATIONSHIP. IN AGREEMENT WITH THE AUTHORS' ASSESSMENT, THE COMPANY CONSIDERS THAT THE EVENTS OF ALANINE AMINOTRANSFERASE INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED AND BLOOD BILIRUBIN INCREASED ARE RELATED TO THE USE OF BEAD BLOCK DUE TO THE TEMPORAL RELATIONSHIP. IN LINE WITH THE AUTHORS' ASSESSMENT, THE COMPANY CONSIDERS THAT POSTEMBOLIZATION SYNDROME AS NOT-RELATED TO THE USE OF BEAD BLOCK BUT RELATED TO THE EMBOLIZATION PROCEDURE. 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 BEAD BLOCK. 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 |
|---|---|---|---|---|---|---|---|
| 118414 | BEAD BLOCK | SINGLE USE IMPLANTABLE MEDICAL DEVICE | HCG | BIOCOMPATIBLES UK LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| O |