DC BEAD
Report
- Report Number
- 3002124545-2015-00024
- Event Type
- Injury
- Date Received
- April 22, 2015
- Report Date
- April 21, 2015
- Manufacturer
- BIOCOMPATIBLES U.K. LTD.
- Product Code
- HCG
- PMA / PMN Number
- K094018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). DC BEAD WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. EPIRUBICIN IS NOT INDICATED TO BE USED WITH DC BEAD. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE LOT NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED. MEDICAL ASSESSMENT CONCLUDED THAT THE PUBLICATION IDENTIFIED DESCRIBING A CASE OF INTRA-TUMORAL HAEMORRHAGE OCCURRING ONE MONTH AFTER A DEB-TACE PROCEDURE. WHILE INTRA-TUMORAL HAEMORRHAGE IS A KNOWN COMPLICATION OF HCC ITSELF, AND THE TIME DELAY OF THE EVENT IS NOT TYPICAL OF AN ASSOCIATION WITH THE PROCEDURE, THE AUTHORS CLEARLY FEEL THAT IT WAS LIKELY RELATED TO THE DEB-TACE PROCEDURE, AND THIS EVENT IS THEREFORE MEDICALLY REPORTABLE. THIS EVENT IS CURRENTLY UNDER INVESTIGATION BY THE MANUFACTURER AND THE CONCLUSIONS OF THIS INVESTIGATION/ANY NEW INFORMATION RECEIVED WILL BE COMMUNICATED AS A FOLLOW-UP REPORT.
COMPANY (B)(4). DC BEAD WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. MANUFACTURER ANALYSIS: A BATCH RECORD REVIEW AND VISUAL INSPECTION OF A RETAINED SAMPLE COULD NOT BE PERFORMED AS NO BATCH NUMBER FOR THE COMPLAINT HAS BEEN PROVIDED. THE COMPANY REPORTING AND MEDICAL ASSESSMENTS CONCLUDED THAT THE COMPLAINT WAS MEDICALLY REPORTABLE DUE TO THE AUTHORS ATTRIBUTION OF CAUSALITY TO THE PROCEDURE. COMPANY ROOT CAUSE ANALYSIS ALSO ASSESSED THAT AN INAPPROPRIATE EMBOLIZATION ENDPOINT DURING TACE PROCEDURE COULD HAVE CONTRIBUTED TO THE EVENT. NO DEVICE MALFUNCTION OR FAILURE WAS IDENTIFIED IN THE COURSE OF THE INVESTIGATION AND NO CAPA ACTIONS HAVE BEEN INITIATED AS A RESULT OF THIS COMPLAINT.
THIS IS A FINAL REPORT PROVIDING THE MANUFACTURER ANALYSIS. INITIAL INFORMATION REPORTED IS AS FOLLOWS: THE INCIDENT HAS BEEN EXTRACTED FROM THE ENCLOSED MEDICAL JOURNAL PUBLICATION, WHICH WAS OBTAINED BY THE MANUFACTURER THROUGH ITS POST-MARKET SURVEILLANCE PROCESS. KAZUE SHIOZAWA ET AL. DELAYED INTRATUMORAL HEMORRHAGE AFTER DRUG-ELUTING BEAD TRANSARTERIAL CHEMOEMBOLIZATION FOR HEPATOCELLULAR CARCINOMA. CASE REPORTS IN ONCOLOGY; 2014; 7: 739-745. THE INFORMATION FROM THE ARTICLE WAS SUMMARIZED WITHIN THIS REPORT. A (B)(6) MALE PATIENT HAD A HISTORY OF HEPATITIS C VIRUS-RELATED CIRRHOSIS. ON ROUTINE ABDOMINAL ULTRASONOGRAPHY (US), A MASS WAS DETECTED IN S5 OF THE LIVER. ON ESOPHAGOGASTRODUODENOSCOPY, A TYPE 0-IIA EARLY GASTRIC CARCINOMA WITH A DIAMETER OF 25 MM WAS DETECTED. CHILD-PUGH CLASS A, AND THE TUMOR MARKERS PIVKA II HAD A LEVEL OF 118 MAU/ML, SHOWING A MILD ELEVATION. THE MASS WAS ENHANCED IN THE VASCULAR PHASE (0-40 S) AND SHOWED A HYPOECHOIC AREA IN THE POST VASCULAR PHASE. BASED ON THE TUMOR MARKER AND IMAGING FINDINGS, THE PATIENT WAS DIAGNOSED WITH HCC. DEE-TACE WAS PERFORMED BECAUSE THE PATIENT DECLINED TO UNDERGO SURGICAL RESECTION OF HCC. AN INTENSELY STAINED TUMOR WAS DETECTED IN THE S5 REGION OF CELIAC ARTERIAL ANGIOGRAPHY. WHEN A MICROCATHETER WAS ADVANCED TO THE ANTERIOR SEGMENTAL ARTERY OF THE RIGHT HEPATIC ARTERY AND CONTRAST IMAGING WAS APPLIED, AN INTENSELY STAINED TUMOR WAS OBSERVED, WITH A5 AS THE FEEDING ARTERY. A SOLUTION IMPREGNATED WITH 100-300 UM DC BEAD AND 50 MG EPIRUBICIN HYDROCHLORIDE, WITH A DC BEAD VOLUME OF 0.35 ML, WAS ADMINISTERED VIA THE FEEDING ARTERY TO PERFORM DEB-TACE. DISAPPEARANCE OF THE INTENSELY STAINED TUMOR IMAGE WAS CONFIRMED BY RIGHT HEPATIC ARTERIAL ANGIOGRAPHY, AND THE TREATMENT WAS COMPLETED. THE COURSE AFTER DEB-TACE WAS FAVORABLE, AND NO ADVERSE EVENTS ABOVE GRADE 3 ACCORDING TO THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) VERSION 4.0 WAS OBSERVED. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) OF THE EARLY GASTRIC CARCINOMA WAS PERFORMED ABOUT 1 MONTH AFTER DEB-TACE. RIGHT HYPOCHONDRIAC PAIN SUDDENLY DEVELOPED 3 DAYS AFTER ESD, BUT NO ADVERSE EVENTS WERE ASSUMED TO BE CAUSED BY ESD (I.E., FREE AIR, NOTED ON DYNAMIC CT). HOWEVER, THE TUMOR DIAMETER HAD INCREASED FROM THAT BEFORE DEB-TACE, AND THE TUMOR SHOWED A HIGH-INTENSITY AREA ON UNENHANCED CT, WHICH WAS NOT ENHANCED IN THE ARTERIAL PHASE ON DYNAMIC CT, SUGGESTING INTRATUMORAL HEMORRHAGE. THE HEMODYNAMICS OF THE TUMOR WERE FOLLOWED USING CEUS OVER THE TIME BEFORE AND AFTER DEB-TACE. ON CEUS CARRIED OUT ON THE DAY AFTER DEB-TACE, THE WHOLE INTRATUMORAL ENHANCEMENT DECREASED, AND NONENHANCED PATCHY REGIONS, ASSUMED TO BE NECROSIS, WERE NOTED IN THE TUMOR IN THE VASCULAR PHASE. ON CEUS PERFORMED 4 WEEKS AFTER DEB-TACE, I.E., IMMEDIATELY BEFORE ESD, THE TUMOR SIZE WAS 33 X 31 MM, AND THE ENHANCEMENT AREA WAS INCREASED IN THE VASCULAR PHASE COMPARED WITH THE CEUS IMAGING OF THE DAY AFTER DEB-TACE. HOWEVER, THE TUMOR HAD ENLARGED TO 41 X 36 MM ON CEUS WHEN THE RIGHT HYPOCHONDRIAC PAIN DEVELOPED (5 WEEKS AFTER DEB-TACE), AND CHANGES IN THE ECHOGENICITY ON GRAY-SCALE US AND NON-ENHANCEMENT OF ALMOST THE ENTIRE TUMOR IN THE VASCULAR PHASE ON CEUS WERE NOTED. BASED ON THE ABOVE FINDINGS, THE CAUSE OF RIGHT HYPOCHONDRIAC PAIN MAY HAVE BEEN DEB-TACE - ASSOCIATED INTRATUMORAL HEMORRHAGE. SINCE THE HEMORRHAGE WAS LIMITED TO INSIDE THE TUMOR, IT STOPPED SPONTANEOUSLY WITH REST. THE AUTHOR STATED THAT, THE TUMOR DIAMETER WAS NOT LARGE AND THE TUMOR WAS DISTINCT FROM THE SUBCAPSULAR REGION. HOWEVER, INTRATUMORAL HEMORRHAGE OCCURRED ABOUT 1 MONTH AFTER DEB-TACE. LOCAL POOLING OF THE CONTRAST AGENT WITHIN THE TARGET TUMOR COULD OCCUR DURING DEB-TACE, THE CAUSE OF THIS LOCAL POOLING REMAINS UNCLEAR BUT IT WAS A LOCAL HEMORRHAGE DUE TO INTRATUMOR VASCULAR COLLAPSE AS A CONSEQUENCE OF THE TREATMENT. INJECTED BEADS CAN EASILY ESCAPE INTO THE POOLING SPACE. WHEN LOCAL POOLING OF THE CONTRAST AGENT WAS NOTED, ADDED A SMALL AMOUNT OF GELATIN SPONGE PARTICLES, WITH A DIAMETER RANGING FROM 1 TO 2 MM, TO THE FEEDING ARTERY UNTIL THE POOLING DISAPPEARED. BASED ON THESE FINDINGS, THE OBSERVATION OF LOCAL POOLING OF THE CONTRAST AGENT WITHIN THE TARGET TUMOR DURING TREATMENT SUGGESTS THAT INTRATUMORAL PRESSURE HAS ALREADY INCREASED, WHICH WAS UNLIKELY IN THIS PATIENT. TREATMENT-INDUCED INTRATUMORAL HEMORRHAGE CONTINUED IMMEDIATELY AFTER DEB-TACE BECAUSE NO POOLING WAS NOTED DURING TREATMENT OR ON CONFIRMATION ANGIOGRAPHY FOLLOWING TREATMENT. THE PHYSICIAN CONSIDERED THAT EMBOLIZATION WAS SUFFICIENT DURING TREATMENT BUT ALSO FELT THAT IT WAS POSSIBLE THAT THE AMOUNT OF DC BEAD WAS INSUFFICIENT AND EMBOLIZATION WAS INCOMPLETE. IT WAS ASSUMED THAT INCOMPLETE EMBOLIZATION SUBSEQUENTLY CAUSED INTRATUMORAL VASCULAR COLLAPSE, I.E., A PHENOMENON SIMILAR TO POOLING, AND THAT THE HEMORRHAGE EXPANDED TO THE NECROTIC INTRATUMORAL AREA BY SUSTAINED RELEASE OF THE CHEMOTHERAPEUTIC AGENT AND EMBOLIZATION, LEADING TO COMPLICATION OF INTRATUMORAL HEMORRHAGE DESPITE THE LOW RISK OF TUMOR HEMORRHAGE.
THE INCIDENT HAS BEEN EXTRACTED FROM THE ENCLOSED MEDICAL JOURNAL PUBLICATION, WHICH WAS OBTAINED BY THE MANUFACTURER THROUGH ITS POST-MARKET SURVEILLANCE PROCESS. KAZUE SHIOZAWA ET AL . DELAYED INTRATUMORAL HEMORRHAGE AFTER DRUG-ELUTING BEAD TRANSARTERIAL CHEMOEMBOLIZATION FOR HEPATOCELLULAR CARCINOMA. CASE REPORTS IN ONCOLOGY; 2014; 7: 739-745. THE INFORMATION FROM THE ARTICLE WAS SUMMARIZED WITHIN THIS REPORT. AN (B)(6) MALE PATIENT HAD A HISTORY OF (B)(6) VIRUS-RELATED CIRRHOSIS. ON ROUTINE ABDOMINAL ULTRASONOGRAPHY (US), A MASS WAS DETECTED IN S5 OF THE LIVER. ON ESOPHAGOGASTRODUODENOSCOPY, A TYPE 0-IIA EARLY GASTRIC CARCINOMA WITH A DIAMETER OF 25 MM WAS DETECTED. CHILD-PUGH CLASS A, AND THE TUMOR MARKERS PIVKA II HAD A LEVEL OF 118 MAU/ML, SHOWING A MILD ELEVATION . THE MASS WAS ENHANCED IN THE VASCULAR PHASE (0-40 S) A ND SHOWED A HYPOECHOIC AREA IN THE POSTVASCULAR PHASE . BASED ON THE TUMOR MARKER AND IMAGING FINDINGS, THE PATIENT WAS DIAGNOSED WITH HCC . DEB-TACE WAS PERFORMED BECAUSE THE PATIENT DECLINED TO UNDERGO SURGICAL RESECTION OF HCC. AN INTENSELY STAINED TUMOR WAS DETECTED IN THE S5 REGION ON CELIAC ARTERIAL ANGIOGRAPHY. WHEN A MICROCATHETER WAS ADVANCED TO THE ANTERIOR SEGMENTAL ARTERY OF THE RIGHT HEPATIC ARTERY AND CONTRAST IMAGING WAS APPLIED, AN INTENSELY STAINED TUMOR WAS OBSERVED, WITH A5 AS THE FEEDING ARTERY. A SOLUTION IMPREGNATED WITH 100-300 UM DC BEAD AND 50 MG EPIRUBICIN HYDROCHLORIDE, WITH A DC BEAD VOLUME OF 0.35 ML, WAS ADMINISTERED VIA THE FEEDING ARTERY TO PERFORM DEB-TACE. DISAPPEARANCE OF THE INTENSELY STAINED TUMOR IMAGE WAS CONFIRMED BY RIGHT HEPATIC ARTERIAL ANGIOGRAPHY, AND THE TREATMENT WAS COMPLETED. THE COURSE AFTER DEB-TACE WAS FAVORABLE, AND NO ADVERSE EVENTS ABOVE GRADE 3 ACCORDING TO THE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE) VERSION 4.0 WERE OBSERVED. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) OF THE EARLY GASTRIC CARCINOMA WAS PERFORMED ABOUT 1 MONTH AFTER DEB-TACE. RIGHT HYPOCHONDRIAC PAIN SUDDENLY DEVELOPED 3 DAYS AFTER ESD, BUT NO ADVERSE EVENTS WERE ASSUMED TO BE CAUSED BY ESD (I.E., FREE AIR, NOTED ON DYNAMIC CT). HOWEVER, THE TUMOR DIAMETER HAD INCREASED FROM THAT BEFORE DEB-TACE, AND THE TUMOR SHOWED A HIGH-INTENSITY AREA ON UNENHANCED CT, WHICH WAS NOT ENHANCED IN THE ARTERIAL PHASE ON DYNAMIC CT, SUGGESTING INTRATUMORAL HEMORRHAGE. THE HEMODYNAMICS OF THE TUMOR WERE FOLLOWED USING CEUS OVER THE TIME BEFORE AND AFTER DEB-TACE. ON CEUS CARRIED OUT ON THE DAY AFTER DEB-TACE, THE WHOLE INTRATUMORAL ENHANCEMENT DECREASED, AND NONENHANCED PATCHY REGIONS, ASSUMED TO BE NECROSIS, WERE NOTED IN THE TUMOR IN THE VASCULAR PHASE. ON CEUS PERFORMED 4 WEEKS AFTER DEB-TACE, I. E., IMMEDIATELY BEFORE ESD, THE TUMOR SIZE WAS 33 X 31 MM, AND THE ENHANCEMENT AREA WAS INCREASED IN THE VASCULAR PHASE COMPARED WITH THE CEUS IMAGING OF THE DAY AFTER DEB-TACE. HOWEVER, THE TUMOR HAD ENLARGED TO 41 X 36 MM ON CEUS WHEN THE RIGHT HYPOCHONDRIAC PAIN DEVELOPED (5 WEEKS AFTER DEB-TACE), AND CHANGES IN THE ECHOGENICITY ON GRAY-SCALE US AND NONENHANCEMENT OF ALMOST THE ENTIRE TUMOR IN THE VASCULAR PHASE ON CEUS WERE NOTED. BASED ON THE ABOVE FINDINGS, THE CAUSE OF RIGHT HYPOCHONDRIAC PAIN MAY HAVE BEEN DEB-TACE-ASSOCIATED INTRATUMORAL HEMORRHAGE. SINCE THE HEMORRHAGE WAS LIMITED TO INSIDE THE TUMOR, IT STOPPED SPONTANEOUSLY WITH REST. THE AUTHOR STATED THAT, THE TUMOR DIAMETER WAS NOT LARGE AND THE TUMOR WAS DISTINCT FROM THE SUBCAPSULAR REGION. HOWEVER, INTRATUMORAL HEMORRHAGE OCCURRED ABOUT 1 MONTH AFTER DEB-TACE. LOCAL POOLING OF THE CONTRAST AGENT WITHIN THE TARGET TUMOR COULD OCCUR DURING DEB-TACE, THE CAUSE OF THIS LOCAL POOLING REMAINS UNCLEAR BUT IT WAS A LOCAL HEMORRHAGE DUE TO INTRATUMOR VASCULAR COLLAPSE AS A CONSEQUENCE OF THE TREATMENT. INJECTED BEADS CAN EASILY ESCAPE INTO THE POOLING SPACE. WHEN LOCAL POOLING OF THE CONTRAST AGENT WAS NOTED, ADDED A SMALL AMOUNT OF GELATIN SPONGE PARTICLES, WITH A DIAMETER RANGING FROM 1 TO 2 MM, TO THE FEEDING ARTERY UNTIL THE POOLING DISAPPEARED. BASED ON THESE FINDINGS, THE OBSERVATION OF LOCAL POOLING OF THE CONTRAST AGENT WITHIN THE TARGET TUMOR DURING TREATMENT SUGGESTS THAT INTRATUMORAL PRESSURE HAS ALREADY INCREASED, WHICH WAS UNLIKELY IN THIS PATIENT'S TREATMENT-INDUCED INTRATUMORAL HEMORRHAGE CONTINUED IMMEDIATELY AFTER DEB-TACE BECAUSE NO POOLING WAS NOTED DURING TREATMENT OR ON CONFIRMATION ANGIOGRAPHY FOLLOWING TREATMENT. THE PHYSICIAN CONSIDERED THAT EMBOLIZATION WAS SUFFICIENT DURING TREATMENT BUT ALSO FELT THAT IT WAS POSSIBLE THAT THE AMOUNT OF DC BEAD WAS INSUFFICIENT AND EMBOLIZATION WAS INCOMPLETE. IT WAS ASSUMED THAT INCOMPLETE EMBOLIZATION SUBSEQUENTLY CAUSED INTRATUMORAL VASCULAR COLLAPSE, I.E., A PHENOMENON SIMILAR TO POOLING, AND THAT THE HEMORRHAGE EXPANDED TO THE NECROTIC INTRATUMORAL AREA BY SUSTAINED RELEASE OF THE CHEMOTHERAPEUTIC AGENT AND EMBOLIZATION, LEADING TO COMPLICATION OF INTRATUMORAL HEMORRHAGE DESPITE THE LOW RISK OF TUMOR HEMORRHAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268849 | DC BEAD | EMBOLIC AGENT | HCG | BIOCOMPATIBLES U.K. LTD. | 100-300 UM | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |