LC BEAD
Report
- Report Number
- 3002124543-2015-00002
- Event Type
- Injury
- Date Received
- February 27, 2020
- Report Date
- January 7, 2015
- Manufacturer
- BIOCOMPATIBLES UK LTD
- Product Code
- KRD
- PMA / PMN Number
- K094018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
LC BEAD WAS USED IN COMBINATION WITH IRINOTECAN. LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. LC BEAD IS NOT INDICATED FOR USE WITH DRUGS. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. BATCH REVIEW WILL NOT BE POSSIBLE FOR THIS CASE IF THE REPORTER DOES NOT SPECIFY LOT NUMBER. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED GIVEN CASE INFORMATION. MEDICAL ASSESSMENT STATED THAT THE COMPLAINT INVOLVES ONE OR MORE PATIENTS WHO DEVELOPED ABSCESS FOLLOWING DEBIRI TREATMENT. FURTHER INFORMATION IS REQUIRED BUT THE REPORT IS MEDICALLY REPORTABLE. FOLLOW UP WAS REQUESTED TO OBTAIN FURTHER INFORMATION ABOUT THE INDIVIDUAL PATIENTS. 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. THE MANUFACTURER REPORT NUMBER IS 3002124545-2015-00002.
LC BEAD WAS USED IN COMBINATION WITH IRINOTECAN. LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. LC BEAD IS NOT INDICATED FOR USE WITH DRUGS. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. BATCH REVIEW WILL NOT BE POSSIBLE FOR THIS CASE IF THE REPORTER DOES NOT SPECIFY LOT NUMBER. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED GIVEN CASE INFORMATION. MEDICAL ASSESSMENT STATED THAT THE COMPLAINT INVOLVES ONE OR MORE PATIENTS WHO DEVELOPED ABSCESS FOLLOWING DEBIRI TREATMENT. FURTHER INFORMATION IS REQUIRED BUT THE REPORT IS MEDICALLY REPORTABLE. FOLLOW UP WAS REQUESTED TO OBTAIN FURTHER INFORMATION ABOUT THE INDIVIDUAL PATIENTS. 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. FOLLOW-UP INFORMATION RECEIVED FROM THE MARKETING AUTHORIZATION HOLDER ON 30-DEC15: AS OF 30-DEC-2015, NUMEROUS FOLLOW-UP ATTEMPTS WERE MADE TO OBTAIN FOLLOW-UP INFORMATION FROM THE PHYSICIAN WITHOUT SUCCESS. THE CUSTOMER COMPLAINT INVESTIGATION IS CLOSED. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY BIOCOMPATIBLES UK LTD THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EFFECT. THE MANUFACTURER REPORT NUMBER IS 3002124545-2015-00002.
INCREASED HEPATIC ABSCESS RATE [LIVER ABSCESS], OFF-LABEL USE OF LC BEAD [OFF LABEL USE OF DEVICE]. CASE DESCRIPTION: INITIAL INFORMATION WAS RECEIVED FROM A PHYSICIAN VIA THE COMPANY MEDICAL SCIENCE LIAISON ON 07JAN2015. THIS IS A MULTIPLE PATIENT REPORT OF POSSIBLE INCREASED ABSCESS RATE IN ONE OR TWO PATIENTS. ON AN UNKNOWN DATE, THE PATIENTS RECEIVED LC BEAD LOADED WITH IRINOTECAN FOR MCRC. THE PHYSICIAN STATED THAT HE HAS TREATED ABOUT 12 PATIENTS OVER THE LAST TWO AND HALF YEARS AND FELT THAT THERE MAY BE AN INCREASED ABSCESS RATE IN ONE OR POSSIBLY TWO OF THE TREATED PATIENTS. THE PHYSICIAN CONFIRMED THAT THE PATIENTS WERE REFERRED TO THE PHYSICIAN FOR FOLLOW UP AND BY THE TIME THESE PATIENTS WERE REFERRED TO HIM, THEY WERE HEAVILY PRETREATED WITH SYSTEMIC CHEMOTHERAPY. THE OUTCOME OF THE EVENTS WAS UNKNOWN AT THE TIME OF THIS REPORT. THE REPORTING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT AND FURTHER FOLLOW UP WILL BE REQUESTED. FOLLOW-UP INFORMATION WAS RECEIVED ON 02-DEC-2015: A CUSTOMER COMPLAINT INVESTIGATION WAS COMPLETED ON 2-DEC-2015. THE RISK ASSESSMENT (REPORTING AND MEDICAL ASSESSMENTS) SECTION STATED THAT THE COMPLAINT APPARENTLY INVOLVES ONE OR MORE PATIENTS WHO DEVELOPED ABSCESS (PRESUMABLY HEPATIC) FOLLOWING DEB-TACE TREATMENT WITH LC BEAD. 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 OVERALL RISK ASSESSMENT SECTION OF THE REPORT STATES THAT THE COMPLAINT ENCOMPASSES OFF-LABEL USE OF LC BEAD IN THE US WHERE IT IS NOT APPROVED BY THE US FDA FOR DRUG LOADING. NO BATCH NUMBERS HAD BEEN PROVIDED FROM THE PHYSICIAN. THE OUTCOME OF THE EVENT IS UNKNOWN. COMPANY COMMENT: THE REPORTED EVENT OF LIVER ABSCESS IS CONSIDERED TO BE LISTED ACCORDING TO LC BEAD CURRENT REFERENCE SAFETY INFORMATION WHEREAS THE OFF-LABEL USE IS CONSIDERED UNLISTED. IN THE ABSENCE OF AN ASSESSMENT BY THE PHYSICIAN, THE COMPANY CONSIDERS THE EVENT OF LIVER ABSCESS TO BE RELATED TO THE USE OF LC BEAD. THE COMPANY CONSIDERS OFF-LABEL USE OF THE DEVICE AS NOT-ASSESSABLE. 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. FOLLOW-UP INFORMATION IS NOT EXPECTED. THIS IS A FINAL REPORT.
INCREASED HEPATIC ABSCESS RATE [LIVER ABSCESS], OFF-LABEL USE OF LC BEAD [OFF LABEL USE OF DEVICE]. CASE DESCRIPTION: INITIAL INFORMATION WAS RECEIVED FROM A PHYSICIAN VIA THE COMPANY MEDICAL SCIENCE LIAISON ON 07JAN2015. THIS IS A MULTIPLE PATIENT REPORT OF POSSIBLE INCREASED ABSCESS RATE IN ONE OR TWO PATIENTS. ON AN UNKNOWN DATE, THE PATIENTS RECEIVED LC BEAD LOADED WITH IRINOTECAN FOR MCRC. THE PHYSICIAN STATED THAT HE HAS TREATED ABOUT 12 PATIENTS OVER THE LAST TWO AND HALF YEARS AND FELT THAT THERE MAY BE AN INCREASED ABSCESS RATE IN ONE OR POSSIBLY TWO OF THE TREATED PATIENTS. THE PHYSICIAN CONFIRMED THAT THE PATIENTS WERE REFERRED TO THE PHYSICIAN FOR FOLLOW UP AND BY THE TIME THESE PATIENTS WERE REFERRED TO HIM, THEY WERE HEAVILY PRETREATED WITH SYSTEMIC CHEMOTHERAPY. THE OUTCOME OF THE EVENTS WAS UNKNOWN AT THE TIME OF THIS REPORT. THE REPORTING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT AND FURTHER FOLLOW UP WILL BE REQUESTED. FOLLOW-UP INFORMATION WAS RECEIVED ON 02-DEC-2015: A CUSTOMER COMPLAINT INVESTIGATION WAS COMPLETED ON 2-DEC-2015. THE RISK ASSESSMENT (REPORTING AND MEDICAL ASSESSMENTS) SECTION STATED THAT THE COMPLAINT APPARENTLY INVOLVES ONE OR MORE PATIENTS WHO DEVELOPED ABSCESS (PRESUMABLY HEPATIC) FOLLOWING DEB-TACE TREATMENT WITH LC BEAD. 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 OVERALL RISK ASSESSMENT SECTION OF THE REPORT STATES THAT THE COMPLAINT ENCOMPASSES OFF-LABEL USE OF LC BEAD IN THE US WHERE IT IS NOT APPROVED BY THE US FDA FOR DRUG LOADING. NO BATCH NUMBERS HAD BEEN PROVIDED FROM THE PHYSICIAN. THE OUTCOME OF THE EVENT IS UNKNOWN. COMPANY COMMENT: THE REPORTED EVENT OF LIVER ABSCESS IS CONSIDERED TO BE LISTED ACCORDING TO LC BEAD CURRENT REFERENCE SAFETY INFORMATION WHEREAS THE OFF-LABEL USE IS CONSIDERED UNLISTED. IN THE ABSENCE OF AN ASSESSMENT BY THE PHYSICIAN, THE COMPANY CONSIDERS THE EVENT OF LIVER ABSCESS TO BE RELATED TO THE USE OF LC BEAD. THE COMPANY CONSIDERS OFF-LABEL USE OF THE DEVICE AS NOT-ASSESSABLE. 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. FOLLOW-UP INFORMATION RECEIVED FROM THE MARKETING AUTHORIZATION HOLDER ON 30-DEC-15: AS OF 30-DEC-2015, NUMEROUS FOLLOW-UP ATTEMPTS WERE MADE TO OBTAIN FOLLOW-UP INFORMATION FROM THE PHYSICIAN WITHOUT SUCCESS. THE CUSTOMER COMPLAINT INVESTIGATION IS CLOSED. FOLLOW-UP INFORMATION IS NOT EXPECTED. THIS IS A FINAL REPORT.
LC BEAD WAS USED IN COMBINATION WITH IRINOTECAN. LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. LC BEAD IS NOT INDICATED FOR USE WITH DRUGS. THE DEVICE HAS NOT BEEN SENT TO THE MANUFACTURER FOR EVALUATION. BATCH REVIEW WILL NOT BE POSSIBLE FOR THIS CASE IF THE REPORTER DOES NOT SPECIFY LOT NUMBER. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED GIVEN CASE INFORMATION. MEDICAL ASSESSMENT STATED THAT THE COMPLAINT INVOLVES ONE OR MORE PATIENTS WHO DEVELOPED ABSCESS FOLLOWING DEBIRI TREATMENT. FURTHER INFORMATION IS REQUIRED BUT THE REPORT IS MEDICALLY REPORTABLE. FOLOW UP WAS REQUESTED TO OBTAIN FURTHER INFORMATION ABOUT THE INDIVIDUAL PATIENTS. 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.
INITIAL INFORMATION WAS RECEIVED FROM A PHYSICIAN VIA THE COMPANY MEDICAL SCIENCE LIAISON ON (B)(6) 2015. THIS IS A MULTIPLE PATIENT REPORT OF POSSIBLE INCREASED ABSCESS RATE IN ONE OR TWO PATIENTS. ON AN UNKNOWN DATE, THE PATIENTS RECEIVED LC BEAD LOADED WITH IRINOTECAN FOR MCRC. THE PHYSICIAN STATED THAT HE HAS TREATED ABOUT 12 PATIENTS OVER THE LAST TWO AND HALF YEARS AND FELT THAT THERE MAY BE AN INCREASED ABSCESS RATE IN ONE OR POSSIBLY TWO OF THE TREATED PATIENTS. THE PHYSICIAN CONFIRMED THAT THE PATIENTS WERE REFERRED TO THE PHYSICIAN FOR FOLLOW UP AND BY THE TIME THESE PATIENTS WERE REFERRED TO HIM, THEY WERE HEAVILY PRETREATED WITH SYSTEMIC CHEMOTHERAPY. THE OUTCOME OF THE EVENTS WAS UNKNOWN AT THE TIME OF THIS REPORT. THE REPORTING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT AND FURTHER FOLLOW UP WILL BE REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228438 | LC BEAD | HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE, PRODUCT CODE: KRD | KRD | BIOCOMPATIBLES UK LTD | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | IRINOTECAN HYDROCHLORIDE(IRINOTECAN HYDROCHLORIDE)| IRINOTECAN HYDROCHLORIDE(IRINOTECAN HYDROCHLORIDE) |