DC BEAD
Report
- Report Number
- 3002124545-2015-00058
- Event Type
- Injury
- Date Received
- September 2, 2015
- Date of Event
- May 27, 2015
- Report Date
- August 20, 2015
- Manufacturer
- BIOCOMPATIBLES UK LTD
- Product Code
- HCG
- PMA / PMN Number
- K094018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
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. DC BEAD WITH EPIRUBICIN IS CONSIDERED OFF-LABEL USE. 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.
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. DC BEAD WITH EPIRUBICIN IS CONSIDERED OFF-LABEL USE. 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.
DC BEAD WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. DC BEAD WITH EPIRUBICIN IS CONSIDERED OFF-LABEL USE. CASE COMMENT: THIS CASE DOCUMENTS AN OFF-LABEL USE OF DC BEAD SINCE DEB-TACE WAS PERFORMED USING DC BEAD LOADED WITH EPIRUBICIN, WHEREAS DC BEAD IS INDICATED ONLY FOR USE WITH DOXORUBICIN AND IRINOTECAN. THE PHYSICIAN CONSIDERED THE EVENT (ABSCESS) AS POSSIBLY RELATED TO THE USE OF DC BEAD, ALTHOUGH HIS POORLY CONTROLLED DIABETES MELLITUS MAY HAVE BEEN RELATED TO THE EVENT. THE COMPANY CONSIDERED ALSO THE EVENT EXPERIENCED BY THE PATIENT AS RELATED TO THE PRODUCT, AS ITS ROLE CANNOT BE EXCLUDED. MOREOVER, EVEN IF ABSCESS IS CONSIDERED UNLISTED, INFECTION IS CONSIDERED LISTED ACCORDING TO DC BEAD CURRENT INSTRUCTIONS FOR USE. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF DC 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. THE FIRST SALES FOR DC BEAD IN THE (B)(6) WERE IN 2004. SALES DATA FROM JAN-2010 FOR DC BEAD IS: (B)(4).
LIVER ABSCESS [LIVER ABSCESS] OFF LABEL USE [OFF LABEL USE] CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 20-AUG-2015: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A PHYSICIAN VIA THE COMPANY DISTRIBUTOR, CONCERNING A (B)(6) MALE PATIENT. PATIENT'S MEDICAL HISTORY INCLUDED INTERVERTEBRAL DISC HERNIATION AND CHOLECYSTECTOMY ((B)(6)2013). PATIENT'S CONCOMITANT DISEASE INCLUDED DIABETES MELLITUS, HYPERLIPIDEMIA, HYPERTENSION AND CHRONIC HEPATITIS (NON-B/NON-C). THE PATIENT CONCOMITANT MEDICATION WAS CEFTRIAXONE SODIUM (DOSAGE, INDICATION AND DATE OF ADMINISTRATION NOT REPORTED). ON (B)(6) 2015, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ON (B)(6) 2015 HE UNDERWENT DEB-TACE PERFORMED USING 2 VIALS (4ML) OF DC BEAD (100-300 MICROM) (LOT NUMBER AND EXPIRATION DATE NOT REPORTED) LOADED WITH EPIRUBICIN HYDROCHLORIDE 50 MG (INDICATION NOT SPECIFIED). ON (B)(6) 2015, THE PATIENT WAS DISCHARGED. ON (B)(6) 2015 THE PATIENT DEVELOPED PYREXIA OF 40°C AND ON (B)(6) 2015 HE WAS URGENTLY ADMITTED TO THE HOSPITAL WHERE CT SCAN REVEALED ABSCESS. THE PATIENT WAS TREATED WITH: - MEROPEN (MEROPENEM HYDRATE) 1G/DAY ON (B)(6) 2015, 1.5G/DAY ON (B)(6)2015 AND 0.75G/DAY FROM (B)(6) 2015. - RECOMODULIN (THROMBOMEDULIN ALFA) (DOSE NOT REPORTED) FROM (B)(6) 2015. - NEUART (HUMAN ANTI-THROMBIN III, FREEZE-DRIED CONCENTRATED) (DOSE NOT REPORTED) FROM (B)(6) 2015. ON (B)(6) 2015 THE PATIENT RECEIVED BLOOD TRANSFUSION (10 UNITS). ON (B)(6) 2015 CT REVEALED THAT THE ABSCESS WAS RECOVERING AND THE PATIENT WAS DISCHARGED. ABSCESS WAS CONSIDERED BY THE REPORTER AS POSSIBLY RELATED TO DC-BEAD THERAPY, ALTHOUGH HIS POORLY CONTROLLED DIABETES MELLITUS MAY HAVE BEEN RELATED TO THE EVENT. THE PHYSICIAN ALSO REPORTED THAT THE HEMOCLIP USED IN CHOLECYSTECTOMY PERFORMED IN (B)(6) 2013 HAD OBSTRUCTED THE ANTERIOR SEGMENTAL BRANCH, AND THEREBY THE HEMODYNAMICS WAS CHANGED, AND THE STATE OF OVER-EMBOLIZATION WAS OBSERVED. THE COMPANY CONSIDERS THE EVENT (ABSCESS) SERIOUS, SINCE IT REQUIRED AN URGENT HOSPITALIZATION AND AN EXTENSIVE PHARMACOLOGICAL TREATMENT. MOREOVER, THE COMPANY CONSIDERED THIS CASE AN OFF-LABEL USE OF DC BEAD, SINCE DC BEAD IS INDICATED ONLY FOR USE WITH DOXORUBICIN AND IRINOTECAN AND NOT WITH EPIRUBICIN. ADDITIONAL INFORMATION RECEIVED ON 14-SEP-2015: PATIENT SUFFERED OF HEPATIC CARCINOMA (HCC). BEFORE THE ONSET OF THE LIVER ABSCESS, NO BILOMA WAS OBSERVED. THE ONSET SITE OF THE ABSCESS CORRESPONDED TO THE EMBOLIZATION SITE OF THE CURRENT TACE. POSSIBLE CAUSES OF LIVER ABSCESS: UNDERLYING DISEASE (HCC), HEPATIC CIRRHOSIS, CHRONIC HEPATITIS AND THE CONCURRENT DIABETES MELLITUS, THE EMBOLIZATION SITE AND RANGE: S8, SEGMENT, THE SIZE OF DC BEAD (100-300MICROM), THE ANTICANCER DRUG EPIRUBICIN AND THE CHOLECYSTECTOMY. THE PATIENT'S BILE DUCT SIZE WAS IN THE NORMAL RANGE. PRE-TACE FINDINGS WERE:NUMBER OF TUMOR 1, MAXIMUM TUMOR DIAMETER 50 MM. NUMBER OF TACE PERFORMED TO DATE: ONCE INCLUDING THE CURRENT ONE. THE REPORTING PHYSICIAN'S COMMENTED THAT THE TUMOR WAS PRESENT IN S8 IN THE LIVER, BUT A8 CENTRAL LEVEL HAD BEEN OBSTRUCTED. THEREFORE, HEPATIC ARTERIAL INFUSION WAS PERFORMED IN THE FOLLOWING BLOOD FLOW: THE ANTERIOR SEGMENTAL BRANCH A5 FOLLOWED A8 PERIPHERAL. THE CAUSE OF A8 OBSTRUCTION SEEMED TO BE RELATED TO THE PROCEDURE PERFORMED AT THE TIME OF CHOLECYSTECTOMY. CASE COMMENT: THIS CASE DOCUMENTS AN OFF-LABEL USE OF DC BEAD SINCE DEB-TACE WAS PERFORMED USING DC BEAD LOADED WITH EPIRUBICIN, WHEREAS DC BEAD IS INDICATED ONLY FOR USE WITH DOXORUBICIN AND IRINOTECAN. THE PHYSICIAN CONSIDERED THE EVENT (LIVER ABSCESS) AS POSSIBLY RELATED TO THE USE OF DC BEAD, ALTHOUGH HIS POORLY CONTROLLED DIABETES MELLITUS MAY HAVE BEEN RELATED TO THE EVENT. THE COMPANY CONSIDERED ALSO THE EVENT EXPERIENCED BY THE PATIENT AS RELATED TO THE PRODUCT, AS ITS ROLE CANNOT BE EXCLUDED. MOREOVER, EVEN IF LIVER ABSCESS IS CONSIDERED UNLISTED, INFECTION IS CONSIDERED LISTED ACCORDING TO DC BEAD CURRENT INSTRUCTIONS FOR USE. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF DC 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. THE FOLLOW UP INFORMATION RECEIVED DID NOT CHANGE THE ASSESSMENT OF THE CASE. (B)(4). FINAL ASSESSMENT RECEIVED ON 23-DEC-2015: THE COMPANY CONSIDERED THE EVENT OF LIVER ABSCESS AS RELATED TO THE DC BEAD, AS ITS ROLE CANNOT BE EXCLUDED ALTHOUGH THE PATIENT'S POORLY CONTROLLED DIABETES MELLITUS MAY HAVE CONTRIBUTED TO THE EVENT. LIVER ABSCESS IS CONSIDERED UNLISTED HOWEVER INFECTION IS CONSIDERED LISTED ACCORDING TO DC BEAD CURRENT INSTRUCTIONS FOR USE. THIS CASE DOCUMENTS OFF-LABEL USE OF DC BEAD AS DC BEAD WAS LOADED WITH EPIRUBICIN, WHEN DC BEAD IS INDICATED ONLY FOR USE WITH DOXORUBICIN AND IRINOTECAN. IT HAS BEEN ASSESSED THAT NO CORRECTIVE ACTION IS NECESSARY AT THIS TIME. THIS REPORT IS CONSIDERED FINAL. THE CASE IS CLOSED.
LIVER ABSCESS [LIVER ABSCESS]. OFF LABEL USE [OFF LABEL USE]. INITIAL INFORMATION RECEIVED ON 20-AUG-2015: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A PHYSICIAN VIA THE COMPANY DISTRIBUTOR, CONCERNING A (B)(6) MALE PATIENT. PATIENT'S MEDICAL HISTORY INCLUDED INTERVERTEBRAL DISC HERNIATION AND CHOLECYSTECTOMY ((B)(6) 2013). PATIENT'S CONCOMITANT DISEASE INCLUDED DIABETES MELLITUS, HYPERLIPIDEMIA, HYPERTENSION AND CHRONIC HEPATITIS (NON-B/NON-C). THE PATIENT CONCOMITANT MEDICATION WAS CEFTRIAXONE SODIUM (DOSAGE, INDICATION AND DATE OF ADMINISTRATION NOT REPORTED). ON (B)(6) 2015, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ON (B)(6) 2015 HE UNDERWENT DEB-TACE PERFORMED USING 2 VIALS (4ML) OF DC BEAD (100-300 MICROM) (LOT NUMBER AND EXPIRATION DATE NOT REPORTED) LOADED WITH EPIRUBICIN HYDROCHLORIDE 50 MG (INDICATION NOT SPECIFIED). ON (B)(6) 2015, THE PATIENT WAS DISCHARGED. ON (B)(6) 2015 THE PATIENT DEVELOPED PYREXIA OF 40°C AND ON (B)(6) 2015 HE WAS URGENTLY ADMITTED TO THE HOSPITAL WHERE CT SCAN REVEALED ABSCESS. THE PATIENT WAS TREATED WITH: MEROPEN (MEROPENEM HYDRATE) 1G/DAY ON (B)(6) 2015, 1.5G/DAY ON (B)(6) 2015 AND 0.75G/DAY FROM (B)(6) 2015. RECOMODULIN (THROMBOMEDULIN ALFA) (DOSE NOT REPORTED) FROM (B)(6) 2015. NEUART (HUMAN ANTI-THROMBIN III, FREEZE-DRIED CONCENTRATED) (DOSE NOT REPORTED) FROM (B)(6) 2015. ON (B)(6) 2015 THE PATIENT RECEIVED BLOOD TRANSFUSION (10 UNITS). ON (B)(6) 2015 CT REVEALED THAT THE ABSCESS WAS RECOVERING AND THE PATIENT WAS DISCHARGED. ABSCESS WAS CONSIDERED BY THE REPORTER AS POSSIBLY RELATED TO DC-BEAD THERAPY, ALTHOUGH HIS POORLY CONTROLLED DIABETES MELLITUS MAY HAVE BEEN RELATED TO THE EVENT. THE PHYSICIAN ALSO REPORTED THAT THE HEMOCLIP USED IN CHOLECYSTECTOMY PERFORMED IN (B)(6) 2013 HAD OBSTRUCTED THE ANTERIOR SEGMENTAL BRANCH, AND THEREBY THE HEMODYNAMICS WAS CHANGED, AND THE STATE OF OVER-EMBOLIZATION WAS OBSERVED. THE COMPANY CONSIDERS THE EVENT (ABSCESS) SERIOUS, SINCE IT REQUIRED AN URGENT HOSPITALIZATION AND AN EXTENSIVE PHARMACOLOGICAL TREATMENT. MOREOVER, THE COMPANY CONSIDERED THIS CASE AN OFF-LABEL USE OF DC BEAD, SINCE DC BEAD IS INDICATED ONLY FOR USE WITH DOXORUBICIN AND IRINOTECAN AND NOT WITH EPIRUBICIN. ADDITIONAL INFORMATION RECEIVED ON 14-SEP-2015: PATIENT SUFFERED OF HEPATIC CARCINOMA (HCC). BEFORE THE ONSET OF THE LIVER ABSCESS, NO BILOMA WAS OBSERVED. THE ONSET SITE OF THE ABSCESS CORRESPONDED TO THE EMBOLIZATION SITE OF THE CURRENT TACE. POSSIBLE CAUSES OF LIVER ABSCESS: UNDERLYING DISEASE (HCC), HEPATIC CIRRHOSIS, CHRONIC HEPATITIS AND THE CONCURRENT DIABETES MELLITUS, THE EMBOLIZATION SITE AND RANGE: S8, SEGMENT, THE SIZE OF DC BEAD (100-300MICROM), THE ANTICANCER DRUG EPIRUBICIN AND THE CHOLECYSTECTOMY. THE PATIENT'S BILE DUCT SIZE WAS IN THE NORMAL RANGE. PRE-TACE FINDINGS WERE:NUMBER OF TUMOR 1, MAXIMUM TUMOR DIAMETER 50 MM. NUMBER OF TACE PERFORMED TO DATE: ONCE INCLUDING THE CURRENT ONE. THE REPORTING PHYSICIAN'S COMMENTED THAT THE TUMOR WAS PRESENT IN S8 IN THE LIVER, BUT A8 CENTRAL LEVEL HAD BEEN OBSTRUCTED. THEREFORE, HEPATIC ARTERIAL INFUSION WAS PERFORMED IN THE FOLLOWING BLOOD FLOW: THE ANTERIOR SEGMENTAL BRANCH A5 FOLLOWED A8 PERIPHERAL. THE CAUSE OF A8 OBSTRUCTION SEEMED TO BE RELATED TO THE PROCEDURE PERFORMED AT THE TIME OF CHOLECYSTECTOMY. CASE COMMENT: THIS CASE DOCUMENTS AN OFF-LABEL USE OF DC BEAD SINCE DEB-TACE WAS PERFORMED USING DC BEAD LOADED WITH EPIRUBICIN, WHEREAS DC BEAD IS INDICATED ONLY FOR USE WITH DOXORUBICIN AND IRINOTECAN. THE PHYSICIAN CONSIDERED THE EVENT (LIVER ABSCESS) AS POSSIBLY RELATED TO THE USE OF DC BEAD, ALTHOUGH HIS POORLY CONTROLLED DIABETES MELLITUS MAY HAVE BEEN RELATED TO THE EVENT. THE COMPANY CONSIDERED ALSO THE EVENT EXPERIENCED BY THE PATIENT AS RELATED TO THE PRODUCT, AS ITS ROLE CANNOT BE EXCLUDED. MOREOVER, EVEN IF LIVER ABSCESS IS CONSIDERED UNLISTED, INFECTION IS CONSIDERED LISTED ACCORDING TO DC BEAD CURRENT INSTRUCTIONS FOR USE. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF DC 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. THE FOLLOW UP INFORMATION RECEIVED DID NOT CHANGE THE ASSESSMENT OF THE CASE. THE FIRST SALES FOR DC BEAD IN THE UK WERE IN 2004. SALES DATA FROM (B)(4) 2010 FOR DC BEAD IS: EU 116.815 VIALS AND ROW 59.919 VIALS.
ABSCESS [ABSCESS] OFF LABEL USE [OFF LABEL USE] CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 20-AUG-2015: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A PHYSICIAN VIA THE COMPANY DISTRIBUTOR, CONCERNING A (B)(6) MALE PATIENT. PATIENT'S MEDICAL HISTORY INCLUDED INTERVERTEBRAL DISC HERNIATION AND CHOLECYSTECTOMY ((B)(6) 2013). PATIENT'S CONCOMITANT DISEASE INCLUDED DIABETES MELLITUS, HYPERLIPIDEMIA, HYPERTENSION AND CHRONIC (B)(6). THE PATIENT CONCOMITANT MEDICATION WAS CEFTRIAXONE SODIUM (DOSAGE, INDICATION AND DATE OF ADMINISTRATION NOT REPORTED). ON (B)(6) 2015, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ON (B)(6) 2015 HE UNDERWENT DEB-TACE PERFORMED USING 2 VIALS (4ML) OF DC BEAD (100-300 MICROM) (LOT NUMBER AND EXPIRATION DATE NOT REPORTED) LOADED WITH EPIRUBICIN HYDROCHLORIDE 50 MG (INDICATION NOT SPECIFIED). ON (B)(6) 2015, THE PATIENT WAS DISCHARGED. ON (B)(6) 2015 THE PATIENT DEVELOPED PYREXIA OF 40C AND ON (B)(6) 2015 HE WAS URGENTLY ADMITTED TO THE HOSPITAL WHERE CT SCAN REVEALED ABSCESS. THE PATIENT WAS TREATED WITH: MEROPEN (MEROPENEM HYDRATE) 1G/DAY ON (B)(6) 2015, 1.5G/DAY ON (B)(6) 2015 AND 0.75G/DAY FROM (B)(6) 2015 TO (B)(6) 2015. RECOMODULIN (THROMBOMODULIN ALTA) (DOSE NOT REPORTED) FROM (B)(6) 2015 TO (B)(6) 2015. NEUART (HUMAN ANTI-THROMBIN ILL, FREEZE-DRIED CONCENTRATED) (DOSE NOT REPORTED) FROM (B)(6) 2015 TO (B)(6) 2015. ON (B)(6) 2015 THE PATIENT RECEIVED BLOOD TRANSFUSION (10 UNITS). ON (B)(6) 2015 CT REVEALED THAT THE ABSCESS WAS RECOVERING AND THE PATIENT WAS DISCHARGED. ABSCESS WAS CONSIDERED BY THE REPORTER AS POSSIBLY RELATED TO DC-BEAD THERAPY, ALTHOUGH HIS POORLY CONTROLLED DIABETES MELLITUS MAY HAVE BEEN RELATED TO THE EVENT. THE PHYSICIAN ALSO REPORTED THAT THE HEMOCLIP USED IN CHOLECYSTECTOMY PERFORMED IN (B)(6) 2013 HAD OBSTRUCTED THE ANTERIOR SEGMENTAL BRANCH, AND THEREBY THE HEMODYNAMICS WAS CHANGED, AND THE STATE OF OVER-EMBOLIZATION WAS OBSERVED. THE COMPANY CONSIDERS THE EVENT (ABSCESS) SERIOUS, SINCE IT REQUIRED AN URGENT HOSPITALIZATION AND AN EXTENSIVE PHARMACOLOGICAL TREATMENT. MOREOVER, THE COMPANY CONSIDERED THIS CASE AN OFF-LABEL USE OF DC BEAD, SINCE DC BEAD IS INDICATED ONLY FOR USE WITH DOXORUBICIN AND IRINOTECAN AND NOT WITH EPIRUBICIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 582872 | DC BEAD | HCG/KRD | HCG | BIOCOMPATIBLES UK LTD | 100-300 MICROM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| O |