ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2024-00006
- Event Type
- Death
- Date Received
- June 21, 2024
- Report Date
- June 11, 2024
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY.
INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY.
EVENT VERBATIM [PREFERRED TERM], INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH [HEPATIC FAILURE], POST EMBOLIZATION SYNDROME [POST EMBOLISATION SYNDROME], NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "ASSESSMENT OF SAFETY AND EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION COMBINED WITH CAMRELIZUMAB AND DONAFENIB IN PATIENTS WITH HEPATOCELLULAR CARCINOMA AT BCLC STAGE C: A STUDY OF 20 CASES", MEDICINE, 2024; VOL:103(20), DOI:10.1097/MD.0000000000038174. AN ADULT PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION; EPIRUBICIN HCL (EPIRUBICIN HCL), AT 40 TO 80 MG FOR THERAPEUTIC EMBOLISATION; DONAFENIB TOSYLATE (ZEPSUN) AT 200 MG 2X/DAY (INITIATED WITHIN A WEEK), ORAL FOR HEPATOCELLULAR CARCINOMA; HYDROXYCAMPTOTHECIN (HYDROXYCAMPTOTHECIN) AT 10 TO 20 MG FOR THERAPEUTIC EMBOLISATION; IODIZED OIL (IODIZED OIL) AT 10-20 ML FOR THERAPEUTIC EMBOLISATION; CAMRELIZUMAB (CAMRELIZUMAB) FOR HEPATOCELLULAR CARCINOMA. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "ADVANCED HCC" (ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH), DEVICE USE ISSUE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH), HEPATIC FAILURE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH"; POST EMBOLISATION SYNDROME (DEATH), OUTCOME "FATAL", DESCRIBED AS "POST EMBOLIZATION SYNDROME". THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH", "POST EMBOLIZATION SYNDROME". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE REPORTER CONSIDERED "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH" AND "POST EMBOLIZATION SYNDROME" RELATED TO EPIRUBICIN HCL. THE REPORTER CONSIDERED "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH" AND "POST EMBOLIZATION SYNDROME" ASSOCIATED TO ABSORBABLE GELATIN. CAUSALITY FOR "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH" AND "POST EMBOLIZATION SYNDROME" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION)., COMMENT: CONSIDERING THE PLAUSIBLE DRUG-EVENT TEMPORAL ASSOCIATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCTS GELFOAM AND EPIRUBICIN TO THE REPORTED EVENTS HEPATIC FAILURE, POST EMBOLISATION SYNDROME AND THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION CANNOT BE EXCLUDED IN THE SETTING OF OFF-LABEL USE (TRANSARTERIAL CHEMOEMBOLIZATION (TACE). AS PER THE AUTHOR "THREE PATIENTS (15.0%, 95% CI: 0¿32.1%) SHOWED NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH. THE USE OF TACE ON HCC PATIENTS WITH MULTIPLE INTRAHEPATIC METASTASES OR TUMORS LOCATED IN THE LEFT OR RIGHT LOBE OF THE LIVER MAY LEAD TO LIVER FUNCTION IMPAIRMENT OR FAILURE, AND ULTIMATELY MORTALITY. HENCE, A TIMELY ADJUSTMENT OF THE THERAPEUTIC APPROACH IS ESSENTIAL IN INSTANCES OF INEFFECTIVE TACE TREATMENT OR MULTIFOCAL TUMOR PRESENTATION, OR EXTRAHEPATIC METASTASIS". THIS PATIENTS UNDERLYING HEPATOCELLULAR CARCINOMA IS ASSESSED AS AN ADDITIONAL CONTRIBUTING FACTOR. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM]. INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH [HEPATIC FAILURE], POST EMBOLIZATION SYNDROME [POST EMBOLISATION SYNDROME], NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "ASSESSMENT OF SAFETY AND EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION COMBINED WITH CAMRELIZUMAB AND DONAFENIB IN PATIENTS WITH HEPATOCELLULAR CARCINOMA AT BCLC STAGE C: A STUDY OF 20 CASES", MEDICINE, 2024; VOL:103(20), DOI:10.1097/MD.0000000000038174. AN ADULT PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION; EPIRUBICIN HCL (EPIRUBICIN HCL), AT 40 TO 80 MG FOR THERAPEUTIC EMBOLISATION; DONAFENIB TOSYLATE (ZEPSUN) AT 200 MG 2X/DAY (INITIATED WITHIN A WEEK), ORAL FOR HEPATOCELLULAR CARCINOMA; HYDROXYCAMPTOTHECIN (HYDROXYCAMPTOTHECIN) AT 10 TO 20 MG FOR THERAPEUTIC EMBOLISATION; IODIZED OIL (IODIZED OIL) AT 10-20 ML FOR THERAPEUTIC EMBOLISATION; CAMRELIZUMAB (CAMRELIZUMAB) FOR HEPATOCELLULAR CARCINOMA. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "ADVANCED HCC" (ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH), DEVICE USE ISSUE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH), HEPATIC FAILURE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH"; POST EMBOLISATION SYNDROME (DEATH), OUTCOME "FATAL", DESCRIBED AS "POST EMBOLIZATION SYNDROME". THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH", "POST EMBOLIZATION SYNDROME". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE REPORTER CONSIDERED "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH" AND "POST EMBOLIZATION SYNDROME" RELATED TO EPIRUBICIN HCL. THE REPORTER CONSIDERED "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH" AND "POST EMBOLIZATION SYNDROME" ASSOCIATED TO ABSORBABLE GELATIN. CAUSALITY FOR "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH" AND "POST EMBOLIZATION SYNDROME" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (06AUG2024): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 06AUG2024 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY., COMMENT: CONSIDERING THE PLAUSIBLE DRUG-EVENT TEMPORAL ASSOCIATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCTS GELFOAM AND EPIRUBICIN TO THE REPORTED EVENTS HEPATIC FAILURE, POST EMBOLISATION SYNDROME AND THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION CANNOT BE EXCLUDED IN THE SETTING OF OFF-LABEL USE (TRANSARTERIAL CHEMOEMBOLIZATION (TACE). AS PER THE AUTHOR "THREE PATIENTS (15.0%, 95% CI: 0-32.1%) SHOWED NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH. THE USE OF TACE ON HCC PATIENTS WITH MULTIPLE INTRAHEPATIC METASTASES OR TUMORS LOCATED IN THE LEFT OR RIGHT LOBE OF THE LIVER MAY LEAD TO LIVER FUNCTION IMPAIRMENT OR FAILURE, AND ULTIMATELY MORTALITY. HENCE, A TIMELY ADJUSTMENT OF THE THERAPEUTIC APPROACH IS ESSENTIAL IN INSTANCES OF INEFFECTIVE TACE TREATMENT OR MULTIFOCAL TUMOR PRESENTATION, OR EXTRAHEPATIC METASTASIS". THIS PATIENTS UNDERLYING HEPATOCELLULAR CARCINOMA IS ASSESSED AS AN ADDITIONAL CONTRIBUTING FACTOR. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM] INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH [HEPATIC FAILURE], POST EMBOLIZATION SYNDROME [POST EMBOLISATION SYNDROME]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "ASSESSMENT OF SAFETY AND EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION COMBINED WITH CAMRELIZUMAB AND DONAFENIB IN PATIENTS WITH HEPATOCELLULAR CARCINOMA AT BCLC STAGE C: A STUDY OF 20 CASES", MEDICINE, 2024; VOL:103(20), DOI:10.1097/MD.0000000000038174. AN ADULT PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION; EPIRUBICIN HCL (EPIRUBICIN HCL), AT 40 TO 80 MG FOR THERAPEUTIC EMBOLISATION; DONAFENIB TOSYLATE (ZEPSUN) AT 200 MG 2X/DAY (INITIATED WITHIN A WEEK), ORAL FOR HEPATOCELLULAR CARCINOMA; HYDROXYCAMPTOTHECIN (HYDROXYCAMPTOTHECIN) AT 10 TO 20 MG FOR THERAPEUTIC EMBOLISATION; IODIZED OIL (IODIZED OIL) AT 10-20 ML FOR THERAPEUTIC EMBOLISATION; CAMRELIZUMAB (CAMRELIZUMAB) FOR HEPATOCELLULAR CARCINOMA. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "ADVANCED HCC" (ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH), DEVICE USE ISSUE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH), HEPATIC FAILURE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH"; POST EMBOLISATION SYNDROME (DEATH), OUTCOME "FATAL", DESCRIBED AS "POST EMBOLIZATION SYNDROME". THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH", "POST EMBOLIZATION SYNDROME". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. THE REPORTER CONSIDERED "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH" AND "POST EMBOLIZATION SYNDROME" RELATED TO EPIRUBICIN HCL. THE REPORTER CONSIDERED "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH" AND "POST EMBOLIZATION SYNDROME" ASSOCIATED TO ABSORBABLE GELATIN. CAUSALITY FOR "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH" AND "POST EMBOLIZATION SYNDROME" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (06AUG2024): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 06AUG2024 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY. FOLLOW-UP (26SEP2024): THIS IS A SPONTANEOUS FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION INCLUDED: DEVICE INFORMATION (EVALUATION CODE)., COMMENT: CONSIDERING THE PLAUSIBLE DRUG-EVENT TEMPORAL ASSOCIATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCTS GELFOAM AND EPIRUBICIN TO THE REPORTED EVENTS HEPATIC FAILURE, POST EMBOLISATION SYNDROME AND THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION CANNOT BE EXCLUDED IN THE SETTING OF OFF-LABEL USE (TRANSARTERIAL CHEMOEMBOLIZATION (TACE). AS PER THE AUTHOR "THREE PATIENTS (15.0%, 95% CI: 0-32.1%) SHOWED NO RESPONSE TO THE COMBINED TREATMENT, RESULTING IN LIVER FAILURE AND DEATH. THE USE OF TACE ON HCC PATIENTS WITH MULTIPLE INTRAHEPATIC METASTASES OR TUMORS LOCATED IN THE LEFT OR RIGHT LOBE OF THE LIVER MAY LEAD TO LIVER FUNCTION IMPAIRMENT OR FAILURE, AND ULTIMATELY MORTALITY. HENCE, A TIMELY ADJUSTMENT OF THE THERAPEUTIC APPROACH IS ESSENTIAL IN INSTANCES OF INEFFECTIVE TACE TREATMENT OR MULTIFOCAL TUMOR PRESENTATION, OR EXTRAHEPATIC METASTASIS". THIS PATIENTS UNDERLYING HEPATOCELLULAR CARCINOMA IS ASSESSED AS AN ADDITIONAL CONTRIBUTING FACTOR. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 217673 | ABSORBABLE GELATIN | POWDER, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |