DC BEAD
Report
- Report Number
- 3002124545-2015-00023
- Event Type
- Death
- Date Received
- April 22, 2015
- Report Date
- March 26, 2015
- Manufacturer
- BIOCOMPATIBLES UK LTD
- Product Code
- HCG
- PMA / PMN Number
- K094018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
(B)(4). MFR REPORT # 3002124545-2015-00023. DC BEAD WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. DRUG LOADING DETAILS WERE NOT PROVIDED. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. 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. COMPANY MEDICAL ASSESSMENT CONCLUDED THAT THE PATIENT DEVELOPED LIVER ABSCESS AND THEN A HEPATOBRONCHIAL FISTULA DUE TO THE ABSCESS AFTER DEB-TACE PROCEDURE. THE PATIENT ULTIMATELY DIED SEVERAL MONTHS LATER. WHILE THE AUTHORS STATED THAT THE UNDERLYING CAUSE OF THIS EVENT WAS PROLONGED EFFECT OF DEB-TACE, THE COMPANY MEDICAL ASSESSMENT IS THAT IT IS MORE LIKELY THAT THE EVENTS WERE DUE TO DEVELOPMENT AND PERSISTENCE OF A LIVER ABSCESS THAT DEVELOPED AS A COMPLICATION OF DEB-TACE THERAPY. 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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY BIOCOMPATIBLES UK LTD THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EFFECT. UPDATE 10-DEC-2015: 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. RISK ASSESSMENT: REPORTING AND MEDICAL ASSESSMENTS: THE CASE MEDICAL ASSESSMENT WAS PERFORMED BY A MEDICAL REPRESENTATIVE WHICH STATED: THE PATIENT DEVELOPED A LIVER ABSCESS AND THEN A HEPATOBRONCHIAL FISTULA DUE TO THE ABSCESS AFTER A DEB-TACE PROCEDURE. THE PATIENT ULTIMATELY DIED SEVERAL MONTHS LATER. THEREFORE THIS IS A MEDICALLY REPORTABLE EVENT. AN INITIAL REPORT WAS SUBMITTED VIA THE 3500A MEDWATCH REPORT (B)(4) (3002124545- 2015-00023) TO THE FDA ON 23APR15 AND VIA MEDDEV 2. 12/1 REV 7 TO THE COMPETENT AUTHORITY IN ITALY, ON 02APR15, IN ACCORDANCE WITH BTG-SP- 05.010. COMPLAINT RECURRENCE: THIS COMPLAINT WAS CATEGORIZED AS "LIVER ABSCESS." IN ORDER TO DETERMINE IF A RECURRING PROBLEM OR TREND EXISTED A REVIEW OF PREVIOUS COMPLAINTS RELATING TO THIS TYPE OF EVENTS WAS CONDUCTED ON (B)(4) 2015 . THE ADVERSE EVENTS FOR CATEGORY LIVER ABSCESS HAVE BEEN REVIEWED AND REPORTING RATES FOR THIS CATEGORY REMAINS LOW. (B)(4). OVERALL RISK ASSESSMENT: THERE HAS BEEN NO INCREASED TREND IN THE REPORTING OF THE ADVERSE EVENTS RELATED TO LIVER ABSCESS THAT WOULD INDICATE A WIDER CLINICAL RISK THAT ALTERS THE CURRENT, ESTABLISHED CLINICAL RISK: BENEFIT PROFILE OF THE DEVICE. AS SUCH, NO ADDITIONAL RISK TO PATIENTS OR USERS OUTSIDE THOSE EXPECTED FOR THE DEVICE OR DRUG HAS BEEN IDENTIFIED RELATING TO THIS COMPLAINT. IT SHOULD ALSO BE NOTED THAT LIVER ABSCESS IS A RECOGNIZED COMPLICATION OF THE PROCEDURE AND DOCUMENTED IN THE BASELINE RISK DOCUMENTS. CONCLUSION: THE POTENTIAL CONTRIBUTORY FACTORS WERE INVESTIGATED AND ASSESSED AS PART OF THIS COMPLAINT. NO SINGULAR ROOT CAUSE WAS IDENTIFIED ON THIS OCCASION HOWEVER THE POTENTIAL ROOT CAUSES IDENTIFIED WITHIN THE "PEOPLE" AND "PROCESS AND PROCEDURE" CATEGORIES OF THE RCA COULD NOT BE RULED OUT. NO CAPA HAS BEEN IDENTIFIED AS A RESULT OF THIS COMPLAINT AND THIS REPORT DOES NOT CHANGE THE ESTABLISHED RISK: BENEFIT PROFILE FOR THE PRODUCT. THE INVESTIGATION IS SUMMARISED WITHIN THIS REPORT, NO FURTHER INVESTIGATIONS ARE REQUIRED. NO DEVICE FAILURE, TREND IN A TYPE OF INCIDENT OR UNEXPECTED RISK TO PATIENT OR USERS HEALTH HAS BEEN IDENTIFIED THEREFORE; NO FIELD SAFETY CORRECTIVE ACTION OR PRODUCT RECALL IS REQUIRED. NO RISK TO PATIENTS HAS BEEN IDENTIFIED RELATING TO THIS COMPLAINT AND NO PRODUCT FAILURE HAS BEEN IDENTIFIED. IT IS RECOMMENDED TO CLOSE CUSTOMER COMPLAINT (B)(4).
COMPANY REFERENCE: (B)(4). DC BEAD WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PT. DRUG LOADING DETAILS WERE NOT PROVIDED. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. 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. COMPANY MEDICAL ASSESSMENT CONCLUDED THAT THE PT DEVELOPED LIVER ABSCESS AND THEN A HEPATOBRONCHIAL FISTULA DUE TO THE ABSCESS AND THEN A HEPATOBRONCHIAL FISTULA DUE TO THE ABSCESS AFTER DEB-TACE PROCEDURE. THE PT ULTIMATELY DIED SEVERAL MONTHS LATER. WHILE THE AUTHORS STATED THAT THE UNDERLYING CAUSE OF THIS EVENT WAS PROLONGED EFFECT OF DEB-TACE, THE COMPANY MEDICAL ASSESMENT IS THAT IT IS MORE LIKELY THAT THE EVENTS WERE DUE TO DEVELOPMENT AND PERSISTENCE OF A LIVER ABSCESS THAT DEVELOPED AS A COMPLICATION OF EB-TACE THERAPY. 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.
HEPATIC ABSCESS [LIVER ABSCESS], BILIOBRONCHIAL FISTULA [BRONCHIAL FISTULA], RESPIRATORY DISTRESS [RESPIRATORY DISTRESS]. CASE DESCRIPTION: THE INCIDENT HAS BEEN EXTRACTED FROM THE ENCLOSED MEDICAL JOURNAL PUBLICATION, WHICH WAS OBTAINED BY THE MANUFACTURER THROUGH ITS POST-MARKET SURVEILLANCE PROCESS. ADRIANA TORO ET AL. A LETHAL COMPLICATION AFTER TRANSARTERIAL CHEMOEMBOLIZATION WITH DRUG -ELUTING BEADS FOR HEPATOCELLULAR CARCINOMA. CASE REPORTS IN SURGERY. VOLUME 2015, 6 PAGES. THE INFORMATION FROM THE ARTICLE WAS SUMMARIZED WITHIN THIS REPORT. A (B)(6) CAUCASIAN MAN IN 2011 WAS SUSPECTED OF (B)(6). THE PATIENT WAS DIAGNOSED WITH LIVER CIRRHOSIS SECONDARY TO (B)(6) IN 1999, HISTORY OF HIATUS HERNIA, RIGHT-SIDED NEPHROLITHIASIS, LUMBAR INTERVERTEBRAL DISC HERNIATION, AND PROSTATIC HYPERTROPHY, ALL OF WHICH WERE TREATED MEDICALLY. THE PATIENT WAS PERFORMANCE STATUS ECOG 2. HE HAD CHILD-PUGH CLASS A LIVER FUNCTION, WITH NORMAL LIVER FUNCTION TESTS. HE WAS NOT ELIGIBLE FOR MAJOR LIVER RESECTION. DEB-TACE WAS PERFORMED IN 2011. A DRUG-LOADING SOLUTION WAS PREPARED BY ADDING STERILE WATER TO A VIAL OF DOXORUBICIN HYDROCHLORIDE POWDER. LOADED BEADS WERE ASPIRATED INTO A SYRINGE AND MIXED WITH A NONIONIC CONTRAST MEDIUM. A MICROCATHETER WAS POSITIONED IN THE RIGHT HEPATIC ARTERY AND WAS INJECTED WITH AN EMULSION OF DEB (300-500 M) LOADED WITH DOXORUBICIN 50MG. A SMALL AMOUNT OF THE EMULSION WAS ALSO INJECTED INTO THE LEFT HEPATIC ARTERY FOR EMBOLIZE THE LESION OF THE SEGMENT 4. THREE MONTHS AFTER THE DEB-TACE ALL THE LESIONS TUMOR RESPONSE WAS ASSESSED AS DISAPPEARANCE OF INTRATUMORAL ARTERIAL ENHANCEMENT IN ALL LESIONS, THE PATIENT DID NOT DEVELOP POST-EMBOLIZATION SYNDROME (ABDOMINAL PAIN, NAUSEA, VOMITING, OR FEVER) AND WAS DISCHARGED THE DAY AFTER. TWENTY-EIGHT DAYS AFTER THE PROCEDURE, HE RETURNED WITH RIGHT UPPER QUADRANT ABDOMINAL PAIN AND FEVER (39É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É. ABDOMINAL CT SHOWED A HUGE FLUID COLLECTION IN THE RIGHT LOBE OF THE LIVER AND A NARROW COMMUNICATION BETWEEN THE COLLECTION AND THE THORACIC CAVITY. THERE WERE MULTIPLE ABSCESSES THROUGHOUT THE RIGHT LOBE OF THE LIVER. A BILIOBRONCHIAL FISTULA WAS DIAGNOSED BY BRONCHOSCOPY. THE PATIENT DIED OF ADULT RESPIRATORY DISTRESS SYNDROME 2 WEEKS LATER. THE AUTHOR SPECULATED THAT DEB-TACE HAS A PROLONGED EFFECT ON THE TUMOR AND THE SURROUNDING LIVER, RESULTING IN PROGRESSIVE ENLARGEMENT OF THE NECROTIC AREA. THIS ACTIVITY THAT CAN EXTEND TO THE SURROUNDING HEALTHY HEPATIC TISSUES MAY CONTINUE INDEFINITELY. FOLLOW-UP INFORMATION WAS RECEIVED ON 10-DEC-2015: A CUSTOMER COMPLAINT INVESTIGATION SUMMARY REPORT (B)(4) WAS RELEASED AND APPROVED. 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. IT IS RECOMMENDED TO CLOSE CUSTOMER COMPLAINT. NO FURTHER FOLLOW-UP ANTICIPATED. THIS IS A FINAL REPORT.
THE INCIDENT HAS BEEN EXTRACTED FROM THE ENCLOSED MEDICAL JOURNAL PUBLICATION, WHICH WAS OBTAINED BY THE MANUFACTURER THROUGH ITS POST-MARKET SURVEILLANCE PROCESS. ADRIANA TORO ET AL. A LETHAL COMPLICATION AFTER TRANSARTERIAL CHEMOEMBOLIZATION WITH DRUG-ELUTING BEADS FOR HEPATOCELLULAR CARCINOMA. CASE REPORTS IN SURGERY. VOLUME 2015, 6 PAGES. THE INFORMATION FROM THE ARTICLE WAS SUMMARIZED WITHIN THIS REPORT. A (B)(6) CAUCASIAN MAN IN 2011 WAS SUSPECTED OF HCC. THE PT WAS DIAGNOSED WITH LIVER CIRRHOSIS SECONDARY TO (B)(6)VIRUS INFECTION IN 1999, HISTORY OF HIATUS HERNIA, RIGHT-SIDED NEPHROLITHIASIS, LUMBAR INTERVERTEBRAL DISC HERNIATION, AND PROSTATIC HYPERTROPHY, ALL OF WHICH WERE TREATED MEDICALLY. THE PT WAS PERFORMANCE STATUS ECOG2. HE HAD CHILD-PUGH CLASS A LIVER FUNCTION, WITH NORMAL LIVER FUNCTION TESTS. HE WAS NOT ELIGIBLE FOR MAJOR LIVER RESECTION. DEB-TACE WAS PERFORMED IN 2011. A DRUG-LOADING SOLUTION WAS PREPARED BY ADDING STERILE WATER TO A VIAL OF DOXORUBICIN HYDROCHLORIDE POWDER. LOADED BEADS WERE ASPIRATED INTO A SYRINGE AND MIXED WITH A NONIONIC CONTRAST MEDIUM. A MICROCATHETER WAS POSITIONED IN THE RIGHT HEPATIC ARTERY AND WAS INJECTED WITH AN EMULSION OF DEB (300-500 UM) LOADED WITH DOXORUBICIN 50MG. A SMALL AMOUNT OF THE EMULSION WAS ALSO INJECTED INTO THE LEFT HEPATIC ARTERY FOR EMBOLIZE THE LESION OF THE SEGMENT 4. THREE MONTHS AFTER THE DEB-TACE ALL THE LESIONS TUMOR RESPONSE WAS ASSESSED AS DISAPPEARANCE OF INTRATUMORAL ARTERIAL ENHANCEMENT IN ALL LESIONS, THE PT DID NOT DEVELOP POST-EMBOLIZATION SYNDROME (ABDOMINAL PAIN, NAUSEA, VOMITING, OR FEVER) AND WAS DISCHARGED THE DAY AFTER. TWENTY-EIGHT DAYS AFTER THE PROCEDURE, HE RETURNED WITH RIGHT UPPER QUADRANT ABDOMINAL PAIN AND FEVER (39 DEGREES CELSIUS). ABDOMINAL CT SHOWED A LARGE HYPODENSE AREA IN THE RIGHT LOBE OF THE LIVER MEASURING 78MM X 82MM AND MULTIPLE SMALL HYPODENSE AREAS THROUGHOUT THE RIGHT LOBE, ESPECIALLY IN SEGMENTS 4, 6,7, AND 8. HE WAS ADMITTED TO HOSPITAL, AND A CT GUIDANCE PERCUTANEOUS 10-FR DRAINAGE CATHETER WAS PLACED IN THE LARGE HEPATIC ABSCESS. ANTIBIOTICS (METRONIDAZOLE PLUS TAZOBACTAM) AND PARACETAMOL WERE ADMINISTERED. HIS FEVER AND PAIN RESOLVED WITHIN 48H. AS THE CATHETER CONTINUED TO DRAIN A SMALL AMOUNT OF PURULENT NECROTIC MATERIAL, IT WAS LEFT IN PLACE AFTER DISCHARGE AND HE WAS SEEN DAILY IN THE OUTPUT CLINIC. THE DRAINAGE STOPPED AFTER 2 WEEKS, AND AFTER REPEAT ULTRASONOGRAPHY THE CATHETER WAS REMOVED. THE PT REMAINED ASYMPTOMATIC FOR 10 DAYS AND THEN REPRESENTED WITH RIGHT UPPER QUADRANT ABDOMINAL PAIN AND FEVER. HE WAS ADMITTED TO HOSPITAL, AND WAS TREATED WITH THE SAME ANTIBIOTIC REGIMEN AS PREVIOUSLY. ABDOMINAL CT SHOWED A FLUID COLLECTION AT THE LOCATION OF THE PREVIOUS LARGE ABSCESS. ANOTHER PERCUTANEOUS DRAINAGE CATHETER WAS PLACED, AND 100ML OF GROSSLY PURULENT MATERIAL WAS ASPIRATED. THE ORGANISMS ISOLATED FROM THE ASPIRATED MATERIAL WERE SENSITIVE TO THE ANTIBIOTICS HE WAS RECEIVING. THE DRAINAGE CATHETER WAS LEFT IN PLACE WHILE DRAINAGE OF NECROTIC MATERIAL CONTINUED. AFTER ALMOST 3 WEEKS WHEN HE WAS ASYMPTOMATIC AND THE DRAINAGE HAD STOPPED, THE CATHETER WAS REMOVED. THE PT WAS THEN LOST TO FOLLOW-UP FOR 3 MONTHS BEFORE PRESENTING TO THE EMERGENCY ROOM WITH BILIOPTYSIS AND FEVER (39 DEGREES CELSIUS). ABDOMINAL CT SHOWED A FLUID COLLECTION IN THE RIGHT LOBE OF THE LIVER AND A NARROW COMMUNICATION BETWEEN THE COLLECTION AND THE THORACIC CAVITY. THERE WERE MULTIPLE ABSCESSES THROUGHOUT THE RIGHT LOBE OF THE LIVER. A BILIOBRONCHIAL FISTULA WAS DIAGNOSED BY BRONCHOSCOPY. THE PT DIED OF ADULT RESPIRATORY DISTRESS SYNDROME 2 WEEKS LATER. THE AUTHOR SPECULATED THAT DEB-TACE HAS A PROLONGED EFFECT ON THE TUMOR AND THE SURROUNDING LIVER, RESULTING IN PROGRESSIVE ENLARGEMENT OF THE NECROTIC AREA. THIS ACTIVITY THAT CAN EXTEND TO THE SURROUNDING HEALTHY HEPATIC TISSUES MAY CONTINUE INDEFINITELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268847 | DC BEAD | HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE | HCG | BIOCOMPATIBLES UK LTD | 300 - 500 UM | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death| H |