GELFOAM
Report
- Report Number
- 1810189-2025-00027
- Event Type
- Injury
- Date Received
- November 14, 2025
- Report Date
- October 17, 2025
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MDCP INVESTIGATION SUMMARY AND CONCLUSION: MANUFACTURING SITE INVESTIGATION: AN ADVERSE EVENT COMPLAINT WAS RECEIVED FOR AN UNKNOWN LOT OF GELFOAM. REVIEW OF COMPLAINTS FOR GELFOAM ABSORBABLE MATERIAL RECEIVED WITHIN 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER WERE IDENTIFIED. EXISTING PROCESS CONTROLS, SUCH AS USE OF A SPECIFIC VALIDATED FORMULATION RECIPE AND AUTOMATIC RECORDING OF ALL WEIGHTS AND IDENTITIES OF RAW MATERIALS, DOCUMENTATION AND VERIFICATION OF CRITICAL FORMULATION, PROCESSING, AND STERILIZATION STEPS, AND FINAL RELEASE TESTING OF EACH BATCH TO ASSURE THAT IT MEETS ALL INTERNAL TARGETS AND REGISTERED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION WERE REVIEWED AS A PART OF THIS INVESTIGATION. NO TRENDS WERE NOTED THAT WOULD REQUIRE ADDITIONAL INVESTIGATION. NO RETURNED COMPLAINT SAMPLE WAS RECEIVED. 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] EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM) [OFF LABEL USE], EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM) [DEVICE USE ISSUE], SELECTIVE TACE FAILED THROUGH THE REMAINING THREE CAUDATE ARTERIES [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "SAFETY AND EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION FOR CAUDATE LOBE HEPATOCELLULAR CARCINOMA: LONG-TERM CLINICAL OUTCOMES.", JOURNAL OF VASCULAR & INTERVENTIONAL RADIOLOGY, 2025; DOI:10.1016/J.JVIR.2025.09.038. A 63-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), AT FIRST-LINE TACE, INTRA-ARTERIAL FOR THERAPEUTIC EMBOLISATION; ETHIODIZED OIL (LIPIODOL), INTRA-ARTERIAL FOR HEPATOCELLULAR CARCINOMA, THERAPEUTIC EMBOLISATION; CISPLATIN (CISPLATIN), AT 2 MG/KG (2 MG/KG OF BODY WEIGHT), INTRA-ARTERIAL FOR HEPATOCELLULAR CARCINOMA, THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "SINGLE CAUDATE LOBE HEPATOCELLULAR CARCINOMA (HCC)" (ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM)"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "SELECTIVE TACE FAILED THROUGH THE REMAINING THREE CAUDATE ARTERIES". CLINICAL COURSE: THIS RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF TRANSARTERIAL CHEMOEMBOLIZATION (TACE) AS A FIRST-LINE TREATMENT IN 107 PATIENTS WITH A SINGLE HEPATOCELLULAR CARCINOMA (HCC) TUMOR LOCATED IN THE CAUDATE LOBE (SINGLE CAUDATE LOBE HEPATOCELLULAR CARCINOMA) WITH LONG-TERM FOLLOW-UP. A TOTAL OF 3492 TREATMENT-NAIVE PATIENTS WHO RECEIVED CHEMOEMBOLIZATION BETWEEN (B)(6) 2006 AND (B)(6) 2023 AS FIRST-LINE TREATMENT FOR SINGLE HCC WERE IDENTIFIED. AMONG THESE 3492 PATIENTS, 107 HAD AN HCC LOCATED IN THE CAUDATE LOBE AND WERE ANALYZED IN THIS STUDY. THE SUBSEGMENTAL LOCATIONS OF THE 107 HCCS WERE THE SPIEGEL LOBE (N = 57), THE PARACAVAL PORTION (N = 39), AND THE CAUDATE PROCESS (N = 11). TACE WAS PERFORMED BY ONE OF EIGHT EXPERIENCED INTERVENTIONAL RADIOLOGISTS, EACH WITH AT LEAST 10 YEARS OF EXPERIENCE WITH CHEMOEMBOLIZATION. SUPERIOR MESENTERIC AND CELIAC ARTERIOGRAPHY WAS INITIALLY PERFORMED USING A 5-F CATHETER (ROSCH HEPATIC CATHETER; COOK, BLOOMINGTON, INDIANA) TO ASSESS THE ANATOMY, TUMOR BURDEN, AND PORTAL VEIN PATENCY. ADDITIONAL DIGITAL SUBTRACTION ANGIOGRAMS OF RIGHT AND LEFT HEPATIC ARTERIES WERE OBTAINED TO IDENTIFY THE ARTERIES FEEDING THE CAUDATE LOBE HCC. IF REQUIRED, CONE-BEAM CT WAS USED TO IDENTIFY TUMOR-FEEDING CAUDATE ARTERIES (N = 8). CISPLATIN-BASED CHEMOEMBOLIZATION (DOSE: 2 MG/KG OF BODY WEIGHT) WAS PERFORMED USING A 1.7 (N = 25), 1.8 (N = 23), 1.9 (N = 5), 2.0 (N = 28), 2.2 (N = 7), AND 2.4 (N = 19)-F MICROCATHETER (PROGREATTM/PROGREAT LAMBDA, TERUMO, TOKYO, JAPAN; RENEGADE, BOSTON SCIENTIFIC, MARLBOROUGH, MASSACHUSETTS; CARNELIAN, TOKAI MEDICAL PRODUCTS, KASUGAI-CITY, JAPAN) AND MICROGUIDEWIRE (TRANSEND, BOSTON SCIENTIFIC, MARLBOROUGH, MASSACHUSETTS; MEISTER, ASAHI INTECC, SETO-SHI, JAPAN). A 1:1 EMULSION OF CISPLATIN (DISSOLVED IN SALINE) AND IODIZED OIL (LIPIODOL, GUERBET) WAS INFUSED INTO THE FEEDING ARTERY, FOLLOWED BY EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM, PFIZER, NEW YORK CITY, NEW YORK) OR CALIBRATED (CALI-GEL [150-350 UM OR 350-560 UM IN DIAMETER], HANGZHOU ALICON PHARM SCI. & TEC., HANGZHOU, CHINA; OR NEXSPHERE [100-300 UM OR 300-500 UM IN DIAMETER], NEXT BIOMEDICAL, INCHEON, SOUTH KOREA) GELATIN PARTICLES UNTIL ARTERIAL FLOW STASIS WAS ACHIEVED. POSTEMBOLIC CELIAC ARTERIOGRAPHY WAS PERFORMED TO ENSURE NO VIABLE TUMOR OR ADDITIONAL FEEDING ARTERY EXISTED. PATIENTS WERE INITIALLY FOLLOWED-UP AT 1 MONTH AFTER TACE WITH LABORATORY TESTS AND CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI). PATIENTS WERE THEN SUBSEQUENTLY FOLLOWED-UP EVERY 2-3 MONTHS DURING THE FIRST 2 YEARS, AND THEN EVERY 3-6 MONTHS UNTIL HCC RECURRENCE. TACE WAS REPEATED IN PATIENTS WHO SHOWED AN INSUFFICIENT RESPONSE AFTER A SINGLE SESSION AND IN THOSE WITH RECURRENT TUMORS. IN SOME PATIENTS WITH RESIDUAL OR LOCALLY RECURRENT CAUDATE LOBE HCC FOLLOWING REPEAT TACE, STEREOTACTIC BODY RADIATION THERAPY, OR PERCUTANEOUS ETHANOL INJECTION WERE TREATED WITH ADDITIONAL TACE. SOME PATIENTS WITH NEW TUMORS AT OTHER LIVER SITES DURING FOLLOW-UP WERE TREATED WITH RADIOFREQUENCY ABLATION IF THEY MET THE CRITERIA FOR RADIOFREQUENCY ABLATION. OF THE 107 PATIENTS, 3 (2.8%) EXPERIENCED A SEVERE ADVERSE EVENT. THIS CASE REFERS TO A 63-YEAR-OLD MAN WHO RECEIVED FIRST-LINE TACE FOR A SINGLE CAUDATE LOBE HCC. PORTAL PHASE CONTRAST-ENHANCED CT SHOWS A LARGE (6.4 CM IN DIAMETER) HCC IN THE SPIEGEL LOBE SUBSEGMENT OF THE CAUDATE LOBE. CELIAC ANGIOGRAPHY SHOWS STAINING OF A HYPERVASCULAR TUMOR SUPPLIED BY MULTIPLE CAUDATE ARTERIES; ONE FROM THE RIGHT ANTERIOR HEPATIC ARTERY, TWO FROM THE MIDDLE HEPATIC ARTERY, AND ONE FROM THE LEFT HEPATIC ARTERY. ALTHOUGH SELECTIVE TACE WAS SUCCESSFUL THROUGH THE ONE CAUDATE ARTERY ARISING FROM THE RIGHT ANTERIOR HEPATIC ARTERY, SELECTIVE TACE FAILED THROUGH THE REMAINING THREE CAUDATE ARTERIES. FURTHERMORE, ONE TUMOR-FEEDING CAUDATE ARTERY FROM THE LEFT HEPATIC ARTERY WAS NEGLECTED AT THE TIME OF TACE. HEPATIC ANGIOGRAPHY OBTAINED AT THE TIME OF A SECOND TACE PROCEDURE (2 MONTHS AFTER THE FIRST TACE PROCEDURE) SHOWS PD OF THE CAUDATE LOBE HCC WITH A NEWLY-APPEARED INTRAHEPATIC METASTASIS.THE ACTION TAKEN FOR ABSORBABLE GELATIN, ETHIODIZED OIL AND CISPLATIN WAS UNKNOWN. CAUSALITY FOR "EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM)" AND "SELECTIVE TACE FAILED THROUGH THE REMAINING THREE CAUDATE ARTERIES" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 22DEC2025 FOR ABSORBABLE GELATIN: MDCP INVESTIGATION SUMMARY AND CONCLUSION: MANUFACTURING SITE INVESTIGATION: AN ADVERSE EVENT COMPLAINT WAS RECEIVED FOR AN UNKNOWN LOT OF GELFOAM. REVIEW OF COMPLAINTS FOR GELFOAM ABSORBABLE MATERIAL RECEIVED WITHIN 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER WERE IDENTIFIED. EXISTING PROCESS CONTROLS, SUCH AS USE OF A SPECIFIC VALIDATED FORMULATION RECIPE AND AUTOMATIC RECORDING OF ALL WEIGHTS AND IDENTITIES OF RAW MATERIALS, DOCUMENTATION AND VERIFICATION OF CRITICAL FORMULATION, PROCESSING, AND STERILIZATION STEPS, AND FINAL RELEASE TESTING OF EACH BATCH TO ASSURE THAT IT MEETS ALL INTERNAL TARGETS AND REGISTERED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION WERE REVIEWED AS A PART OF THIS INVESTIGATION. NO TRENDS WERE NOTED THAT WOULD REQUIRE ADDITIONAL INVESTIGATION. NO RETURNED COMPLAINT SAMPLE WAS RECEIVED. 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. SAMPLES ARE NOT AVAILABLE. FOLLOW-UP (22DEC2025): THIS IS A FOLLOW-UP REPORT FROM PFIZER PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. UPDATED INFORMATION: INFORMATION ABOUT SAMPLE AVAILABILITY., COMMENT: THE EVENT "SELECTIVE TACE FAILED THROUGH THE REMAINING THREE CAUDATE ARTERIES" IS ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), AND LISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED.
EVENT VERBATIM [PREFERRED TERM] EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM) [OFF LABEL USE], EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM) [DEVICE USE ISSUE], SELECTIVE TACE FAILED THROUGH THE REMAINING THREE CAUDATE ARTERIES [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "SAFETY AND EFFICACY OF TRANSARTERIAL CHEMOEMBOLIZATION FOR CAUDATE LOBE HEPATOCELLULAR CARCINOMA: LONG-TERM CLINICAL OUTCOMES.", JOURNAL OF VASCULAR & INTERVENTIONAL RADIOLOGY, 2025; DOI:10.1016/J.JVIR.2025.09.038. A 63-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), AT FIRST-LINE TACE, INTRA-ARTERIAL FOR THERAPEUTIC EMBOLISATION; ETHIODIZED OIL (LIPIODOL), INTRA-ARTERIAL FOR HEPATOCELLULAR CARCINOMA, THERAPEUTIC EMBOLISATION; CISPLATIN (CISPLATIN), AT 2 MG/KG (2 MG/KG OF BODY WEIGHT), INTRA-ARTERIAL FOR HEPATOCELLULAR CARCINOMA, THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "SINGLE CAUDATE LOBE HEPATOCELLULAR CARCINOMA (HCC)" (ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM)"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "SELECTIVE TACE FAILED THROUGH THE REMAINING THREE CAUDATE ARTERIES". CLINICAL COURSE: THIS RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF TRANSARTERIAL CHEMOEMBOLIZATION (TACE) AS A FIRST-LINE TREATMENT IN 107 PATIENTS WITH A SINGLE HEPATOCELLULAR CARCINOMA (HCC) TUMOR LOCATED IN THE CAUDATE LOBE (SINGLE CAUDATE LOBE HEPATOCELLULAR CARCINOMA) WITH LONG-TERM FOLLOW-UP. A TOTAL OF 3492 TREATMENT-NAIVE PATIENTS WHO RECEIVED CHEMOEMBOLIZATION BETWEEN JANUARY 2006 AND DECEMBER 2023 AS FIRST-LINE TREATMENT FOR SINGLE HCC WERE IDENTIFIED. AMONG THESE 3492 PATIENTS, 107 HAD AN HCC LOCATED IN THE CAUDATE LOBE AND WERE ANALYZED IN THIS STUDY. THE SUBSEGMENTAL LOCATIONS OF THE 107 HCCS WERE THE SPIEGEL LOBE (N = 57), THE PARACAVAL PORTION (N = 39), AND THE CAUDATE PROCESS (N = 11). TACE WAS PERFORMED BY ONE OF EIGHT EXPERIENCED INTERVENTIONAL RADIOLOGISTS, EACH WITH AT LEAST 10 YEARS OF EXPERIENCE WITH CHEMOEMBOLIZATION. SUPERIOR MESENTERIC AND CELIAC ARTERIOGRAPHY WAS INITIALLY PERFORMED USING A 5-F CATHETER (ROSCH HEPATIC CATHETER; COOK, BLOOMINGTON, INDIANA) TO ASSESS THE ANATOMY, TUMOR BURDEN, AND PORTAL VEIN PATENCY. ADDITIONAL DIGITAL SUBTRACTION ANGIOGRAMS OF RIGHT AND LEFT HEPATIC ARTERIES WERE OBTAINED TO IDENTIFY THE ARTERIES FEEDING THE CAUDATE LOBE HCC. IF REQUIRED, CONE-BEAM CT WAS USED TO IDENTIFY TUMOR-FEEDING CAUDATE ARTERIES (N = 8). CISPLATIN-BASED CHEMOEMBOLIZATION (DOSE: 2 MG/KG OF BODY WEIGHT) WAS PERFORMED USING A 1.7 (N = 25), 1.8 (N = 23), 1.9 (N = 5), 2.0 (N = 28), 2.2 (N = 7), AND 2.4 (N = 19)-F MICROCATHETER (PROGREATTM/PROGREAT LAMBDA, TERUMO, TOKYO, JAPAN; RENEGADE, BOSTON SCIENTIFIC, MARLBOROUGH, MASSACHUSETTS; CARNELIAN, TOKAI MEDICAL PRODUCTS, KASUGAI-CITY, JAPAN) AND MICROGUIDEWIRE (TRANSEND, BOSTON SCIENTIFIC, MARLBOROUGH, MASSACHUSETTS; MEISTER, ASAHI INTECC, SETO-SHI, JAPAN). A 1:1 EMULSION OF CISPLATIN (DISSOLVED IN SALINE) AND IODIZED OIL (LIPIODOL, GUERBET) WAS INFUSED INTO THE FEEDING ARTERY, FOLLOWED BY EMBOLIZATION WITH HAND-CUT, 1-MM DIAMETER GELATIN SPONGE (GELFOAM, PFIZER, NEW YORK CITY, NEW YORK) OR CALIBRATED (CALI-GEL [150-350 UM OR 350-560 UM IN DIAMETER], HANGZHOU ALICON PHARM SCI. & TEC., HANGZHOU, CHINA; OR NEXSPHERE [100-300 UM OR 300-500 UM IN DIAMETER], NEXT BIOMEDICAL, INCHEON, SOUTH KOREA) GELATIN PARTICLES UNTIL ARTERIAL FLOW STASIS WAS ACHIEVED. POSTEMBOLIC CELIAC ARTERIOGRAPHY WAS PERFORMED TO ENSURE NO VIABLE TUMOR OR ADDITIONAL FEEDING ARTERY EXISTED. PATIENTS WERE INITIALLY FOLLOWED-UP AT 1 MONTH AFTER TACE WITH LABORATORY TESTS AND CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI). PATIENTS WERE THEN SUBSEQUENTLY FOLLOWED UP EVERY 2-3 MONTHS DURING THE FIRST 2 YEARS, AND THEN EVERY 3-6 MONTHS UNTIL HCC RECURRENCE. TACE WAS REPEATED IN PATIENTS WHO SHOWED AN INSUFFICIENT RESPONSE AFTER A SINGLE SESSION AND IN THOSE WITH RECURRENT TUMORS. IN SOME PATIENTS WITH RESIDUAL OR LOCALLY RECURRENT CAUDATE LOBE HCC FOLLOWING REPEAT TACE, STEREOTACTIC BODY RADIATION THERAPY, OR PERCUTANEOUS ETHANOL INJECTION WERE TREATED WITH ADDITIONAL TACE. SOME PATIENTS WITH NEW TUMORS AT OTHER LIVER SITES DURING FOLLOW-UP WERE TREATED WITH RADIOFREQUENCY ABLATION IF THEY MET THE CRITERIA FOR RADIOFREQUENCY ABLATION. OF THE 107 PATIENTS, 3 (2.8%) EXPERIENCED A SEVERE ADVERSE EVENT. THIS CASE REFERS TO A 63-YEAR-OLD MAN WHO RECEIVED FIRST-LINE TACE FOR A SINGLE CAUDATE LOBE HCC. PORTAL PHASE CONTRASTENHANCED CT SHOWS A LARGE (6.4 CM IN DIAMETER) HCC IN THE SPIEGEL LOBE SUBSEGMENT OF THE CAUDATE LOBE. CELIAC ANGIOGRAPHY SHOWS STAINING OF A HYPERVASCULAR TUMOR SUPPLIED BY MULTIPLE CAUDATE ARTERIES; ONE FROM THE RIGHT ANTERIOR HEPATIC ARTERY, TWO FROM THE MIDDLE HEPATIC ARTERY, AND ONE FROM THE LEFT HEPATIC ARTERY. ALTHOUGH SELECTIVE TACE WAS SUCCESSFUL THROUGH THE ONE CAUDATE ARTERY ARISING FROM THE RIGHT ANTERIOR HEPATIC ARTERY, SELECTIVE TACE FAILED THROUGH THE REMAINING THREE CAUDATE ARTERIES. FURTHERMORE, ONE TUMOR-FEEDING CAUDATE ARTERY FROM THE LEFT HEPATIC ARTERY WAS NEGLECTED AT THE TIME OF TACE. HEPATIC ANGIOGRAPHY OBTAINED AT THE TIME OF A SECOND TACE PROCEDURE (2 MONTHS AFTER THE FIRST TACE PROCEDURE) SHOWS PD OF THE CAUDATE LOBE HCC WITH A NEWLYAPPEARED INTRAHEPATIC METASTASIS.THE ACTION TAKEN FOR ABSORBABLE GELATIN, ETHIODIZED OIL AND CISPLATIN WAS UNKNOWN. CAUSALITY FOR "EMBOLIZATION WITH HAND-CUT, 1- MM DIAMETER GELATIN SPONGE (GELFOAM)" AND "SELECTIVE TACE FAILED THROUGH THE REMAINING THREE CAUDATE ARTERIES" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION)., COMMENT: THE EVENT "SELECTIVE TACE FAILED THROUGH THE REMAINING THREE CAUDATE ARTERIES" IS ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), AND LISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2714865 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Other| R |