ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2023-00063
- Event Type
- Death
- Date Received
- April 26, 2023
- Date of Event
- November 30, 2018
- Report Date
- April 12, 2023
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION RESULT RECEIVED ON 11DEC2023. CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE 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], FEVER REACHING 39.6 CENTIGRADE [PYREXIA], FAINTED [SYNCOPE], DIFFICULTY BREATHING [DYSPNOEA], LARGE AMOUNT OF GAS IN THE LESIONS AND IN THE PORTAL VEINS [PORTAL VENOUS GAS], STREPTOCOCCUS ANGINOSUS FROM HEPATIC PUNCTURE TUBE DRAINAGE WAS POSITIVE [STREPTOCOCCAL BACTERAEMIA], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE REPORT OF FATAL HEPATIC PORTAL VENOUS GAS AFTER TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION IN A PATIENT WITH HEPATOCELLULAR CARCINOMA", TRANSLATIONAL CANCER RESEARCH, 2021; VOL:10 (12), PGS:5437-5442, DOI:10.21037/TCR-21-1721. A 44-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), SINCE 30NOV2018 AT 350 UM GELATIN SPONGE PARTICLES FOR THERAPEUTIC EMBOLISATION; TRIHEXYPHENIDYL HYDROCHLORIDE (THP), SINCE 30NOV2018 (BATCH/LOT NUMBER: UNKNOWN) AT 60 MG FOR THERAPEUTIC EMBOLISATION; IODIZED OIL (IODIZED OIL), SINCE 30NOV2018 (BATCH/LOT NUMBER: UNKNOWN) AT 4 ML FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "CHRONIC VIRAL HEPATITIS B" (UNSPECIFIED IF ONGOING); "PRIMARY HEPATOCELLULAR CARCINOMA" (UNSPECIFIED IF ONGOING), NOTES: BARCELONA CLINIC LIVER CANCER (BCLC) STAGE B; "TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION", START DATE: 08MAY2018 (UNSPECIFIED IF ONGOING), NOTES: FIRST TACE ON 08MAY2018, FROM AUGUST TO NOVEMBER 2018, THE PATIENT RECEIVED THREE MORE TACE. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PAST DRUG HISTORY INCLUDED: ABSORBABLE GELATIN, START DATE: 08MAY2018, STOP DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "FEVER", NOTES: FIRST TACE, 350 UM GELFOAM SPONGE PARTICLES; ABSORBABLE GELATIN, START DATE: 08MAY2018, STOP DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "SEVERE LIVER DAMAGE", NOTES: FIRST TACE, 350 UM GELFOAM SPONGE PARTICLES; ABSORBABLE GELATIN, START DATE: 08MAY2018, STOP DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "COUGH/PNEUMONIA", NOTES: FIRST TACE, 350 UM GELFOAM SPONGE PARTICLES; ABSORBABLE GELATIN, START DATE: 08MAY2018, STOP DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "PNEUMORACHIS", NOTES: FIRST TACE, 350 UM GELFOAM SPONGE PARTICLES; ABSORBABLE GELATIN, START DATE: 08MAY2018, STOP DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "HEPATIC ABSCESS", NOTES: FIRST TACE, 350 UM GELFOAM SPONGE PARTICLES; THP, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "FEVER", NOTES: FIRST TACE, 30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL; THP, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "SEVERE LIVER DAMAGE", NOTES: FIRST TACE, 30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL; THP, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "COUGH/PNEUMONIA", NOTES: FIRST TACE, 30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL; THP, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "PNEUMORACHIS", NOTES: FIRST TACE, 30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL; THP, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "HEPATIC ABSCESS", NOTES: FIRST TACE, 30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL; IODIZED OIL, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "FEVER", NOTES: FIRST TACE, 8 ML IODIZED OIL; IODIZED OIL, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "SEVERE LIVER DAMAGE", NOTES: FIRST TACE, 8 ML IODIZED OIL; IODIZED OIL, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "COUGH/PNEUMONIA", NOTES: FIRST TACE, 8 ML IODIZED OIL; IODIZED OIL, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "PNEUMORACHIS", NOTES: FIRST TACE, 8 ML IODIZED OIL; IODIZED OIL, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "HEPATIC ABSCESS", NOTES: FIRST TACE, 8 ML IODIZED OIL. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, MEDICALLY SIGNIFICANT) ALL WITH ONSET 30NOV2018, OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION"; PYREXIA (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 01DEC2018, OUTCOME "FATAL", DESCRIBED AS "FEVER REACHING 39.6 CENTIGRADE"; DYSPNOEA (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 03DEC2018, OUTCOME "FATAL", DESCRIBED AS "DIFFICULTY BREATHING"; SYNCOPE (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 03DEC2018, OUTCOME "FATAL", DESCRIBED AS "FAINTED"; STREPTOCOCCAL BACTERAEMIA (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 03DEC2018, OUTCOME "FATAL", DESCRIBED AS "STREPTOCOCCUS ANGINOSUS FROM HEPATIC PUNCTURE TUBE DRAINAGE WAS POSITIVE"; PORTAL VENOUS GAS (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 03DEC2018, OUTCOME "FATAL", DESCRIBED AS "LARGE AMOUNT OF GAS IN THE LESIONS AND IN THE PORTAL VEINS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ALANINE AMINOTRANSFERASE (0-40): (01DEC2018) 163 IU/L; ASPARTATE AMINOTRANSFERASE (0-40): (01DEC2018) 249 IU/L; BACTERIAL TEST: (03DEC2018) STREPTOCOCCUS ANGINOSUS FROM HEPATIC PUNCTURE, NOTES: TUBE DRAINAGE WAS POSITIVE; BLOOD BILIRUBIN (1.71-17.1): (01DEC2018) 73 UMOL/L; BODY TEMPERATURE: (01DEC2018) 39.6 CENTIGRADE, NOTES: FEVER BEGAN THE DAY AFTER TACE; COMPUTERISED TOMOGRAM: (03DEC2018) A LARGE AMOUNT OF GAS IN THE LESIONS AND IN THE, NOTES: PORTAL VEINS; GRANULOCYTE COUNT (50-70): (01DEC2018) 98.5 %; WHITE BLOOD CELL COUNT (4-10): (01DEC2018) 14.1 X10 9/L. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, DEVICE USE ISSUE, PYREXIA, SYNCOPE, DYSPNOEA, PORTAL VENOUS GAS, STREPTOCOCCAL BACTERAEMIA. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "FEVER REACHING 39.6 CENTIGRADE", "FAINTED", "DIFFICULTY BREATHING", "LARGE AMOUNT OF GAS IN THE LESIONS AND IN THE PORTAL VEINS", "STREPTOCOCCUS ANGINOSUS FROM HEPATIC PUNCTURE TUBE DRAINAGE WAS POSITIVE", "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: WE REPORTED A PATIENT WITH HEPATOCELLULAR CARCINOMA DEVELOPED HPVG FOLLOWING TACE, RESULTING IN A POOR PROGNOSIS. PATIENT WITH A HISTORY OF HEPATITIS B WAS DIAGNOSED WITH PRIMARY HEPATOCELLULAR CARCINOMA. THE PATIENT PREVIOUSLY SUFFERED FROM CHRONIC VIRAL HEPATITIS B WITHOUT CIRRHOSIS. MULTIPHASIC CONTRAST-ENHANCED MAGNETIC RESONANCE IMAGING (MRI) SHOWED A 9.8 CM * 7.9 CM MASS IN THE RIGHT HEPATIC LOBE WITH SEVERAL SMALL LESIONS AND ARTERIAL HYPERVASCULARITY. ALPHA-FETOPROTEIN (AFP) WAS GREATER THAN 3,630 NG/ML. ACCORDING TO EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER (EASL) CLINICAL PRACTICE GUIDELINES, THIS PATIENT WAS IDENTIFIED AS BARCELONA CLINIC LIVER CANCER (BCLC) STAGE B, AND TRANSARTERIAL CHEMOEMBOLIZATION IS THE STANDARD TREATMENT. MAY 8, 2018, THE PATIENT WAS TREATED BY THE FIRST TACE (30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL, 8 ML IODIZED OIL, 350 UM GELFOAM SPONGE PARTICLES). AFTER ONE DAY FOLLOWING TACE, THE PATIENT DEVELOPED A FEVER, UP TO A MAXIMUM OF 39.3 CENTIGRADE, AND DEVELOPED SEVERE LIVER DAMAGE. THE LABORATORY TEST SHOWED THAT WHITE BLOOD CELL (WBC) WAS 8.5*109/L (NORMAL RANGE: 4*109-10*109/L), NEUTROPHIL GRANULOCYTE (GRAN) 91.4% (NORMAL RANGE: 50-70%), ALANINE AMINOTRANSFERASE (ALT) 2.6 UPPER LIMIT OF NORMAL VALUE (ULN) (NORMAL RANGE: 0-40 U/L), ASPARTATE AMINOTRANSFERASE (AST) 7.9 ULN (NORMAL RANGE: 0-40 U/L), AND TOTAL BILIRUBIN (TBIL) 1.9 ULN (NORMAL RANGE: 1.71-17.1 UMOL/L). THEN HE RECEIVED TREATMENT FOR LIVER PRESERVATION AND OTHER TREATMENTS. ONE MONTH AFTER TACE, ALT, AST AND TBIL RETURNED TO NORMAL RANGE, WHILE WBC WAS 9.2*109/L AND GRAN WAS 82.7%. AT THE SAME TIME, THE ABDOMINAL ENHANCEMENT MRI SHOWED SIGNIFICANT NECROSIS OF THE LESIONS, WITH AFP DROPPING TO 1,708 NG/ML. HOWEVER, FROM JUNE 15, 2018, THE PATIENT EXPERIENCED REPEATED FEVER AND COUGH, EVEN AFTER ANTI-INFECTION TREATMENT. THE BODY TEMPERATURE REACHED A MAXIMUM OF 39 CENTIGRADE. THE CHEST COMPUTED TOMOGRAPHY (CT) SHOWED PNEUMONIA OCCURRED IN THE RIGHT LUNG, AND PNEUMORACHIS WITH IODINE OIL DEPOSITION OCCURRED IN THE TUMOR LESION IN THE RIGHT LOBE OF THE LIVER, WHICH WAS CONSIDERED AS HEPATIC ABSCESS. WE CONTINUED THE ANTI-INFECTION TREATMENT (TAZOBACTAM SODIUM/PIPERACILLIN SODIUM FOR INJECTIO, 4.5 G Q8H FOR 7 DAYS) AND PIGTAIL CATHETER DRAINAGE WAS ADMINISTERED, BUT THE BACTERIA CULTURE WAS NEGATIVE. ON JULY 31, 2018, A SIGNIFICANT REDUCTION IN THE ORIGINAL LESION IN THE RIGHT LOBE OF THE LIVER WAS OBSERVED BY ENHANCED MRI, BUT THE NUMBER OF NEW LESIONS IN THE LIVER INCREASED AND THE AFP ROSE TO MORE THAN 3,630 NG/ML. FROM AUGUST TO NOVEMBER 2018, THE PATIENT RECEIVED THREE MORE TACE (60 MG THP PLUS 20 ML, 8 ML, 7ML IODIZED OIL, RESPECTIVELY). NOVEMBER 28, 2018, ENHANCED MRI SHOWED SIGNIFICANT NECROSIS AND REDUCTION OF THE LESIONS. NOVEMBER 30, THE PATIENT RECEIVED THE FIFTH TACE (60 MG THP PLUS 4 ML IODIZED OIL PLUS 350 UM GELATIN SPONGE PARTICLES). FEVER BEGAN THE DAY AFTER TACE, REACHING 39.6 CENTIGRADE. THE LABORATORY TEST SHOWED THAT WBC WAS 14.1*109/L, GRAN 98.5%, ALT 163 U/L, AST 249 U/L, TBIL 73 UMOL/L. THEN THE PATIENT RECEIVED ANTI- INFECTION AND LIVER PROTECTION TREATMENT. HOWEVER, THREE DAYS AFTER THE FIFTH TACE, THE PATIENT SUDDENLY FAINTED AND HAD DIFFICULTY BREATHING. THE ENHANCING CT SHOWED A LARGE AMOUNT OF GAS IN THE LESIONS AND IN THE PORTAL VEINS. THE BACTERIA CULTURED SHOWED THAT STREPTOCOCCUS ANGINOSUS FROM HEPATIC PUNCTURE TUBE DRAINAGE WAS POSITIVE. ALTHOUGH AFTER ACTIVE TREATMENT, THE PATIENT DIED TWO HOURS AFTER ENTERING THE INTENSIVE CARE UNIT (ICU). INVESTIGATION RESULT RECEIVED ON 11DEC2023. UDI: 10300100000000. CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE 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. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (11DEC2023): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON INFORMATION PROVIDED, THE REPORTED EVENTS ARE ASSOCIATED WITH ABSORBABLE GELATIN (ABSORBABLE GELATIN). 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 [PREFERRED TERM] INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], FEVER REACHING 39.6 CENTIGRADE [PYREXIA], FAINTED [SYNCOPE], DIFFICULTY BREATHING [DYSPNOEA], LARGE AMOUNT OF GAS IN THE LESIONS AND IN THE PORTAL VEINS [PORTAL VENOUS GAS], STREPTOCOCCUS ANGINOSUS FROM HEPATIC PUNCTURE TUBE DRAINAGE WAS POSITIVE [STREPTOCOCCAL BACTERAEMIA], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE REPORT OF FATAL HEPATIC PORTAL VENOUS GAS AFTER TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION IN A PATIENT WITH HEPATOCELLULAR CARCINOMA", TRANSLATIONAL CANCER RESEARCH, 2021; VOL:10 (12), PGS:5437-5442, DOI:10.21037/TCR-21-1721. A 44-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), SINCE 30NOV2018 AT 350 UM GELATIN SPONGE PARTICLES FOR THERAPEUTIC EMBOLISATION; TRIHEXYPHENIDYL HYDROCHLORIDE (THP), SINCE 30NOV2018 (BATCH/LOT NUMBER: UNKNOWN) AT 60 MG FOR THERAPEUTIC EMBOLISATION; IODIZED OIL (IODIZED OIL), SINCE 30NOV2018 (BATCH/LOT NUMBER: UNKNOWN) AT 4 ML FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "CHRONIC VIRAL HEPATITIS B" (UNSPECIFIED IF ONGOING); "PRIMARY HEPATOCELLULAR CARCINOMA" (UNSPECIFIED IF ONGOING), NOTES: BARCELONA CLINIC LIVER CANCER (BCLC) STAGE B; "TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION", START DATE: 08MAY2018 (UNSPECIFIED IF ONGOING), NOTES: FIRST TACE ON 08MAY2018, FROM AUGUST TO NOVEMBER 2018, THE PATIENT RECEIVED THREE MORE TACE. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PAST DRUG HISTORY INCLUDED: ABSORBABLE GELATIN, START DATE: 08MAY2018, STOP DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "FEVER", NOTES: FIRST TACE, 350 UM GELFOAM SPONGE PARTICLES; ABSORBABLE GELATIN, START DATE: 08MAY2018, STOP DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "SEVERE LIVER DAMAGE", NOTES: FIRST TACE, 350 UM GELFOAM SPONGE PARTICLES; ABSORBABLE GELATIN, START DATE: 08MAY2018, STOP DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "COUGH/PNEUMONIA", NOTES: FIRST TACE, 350 UM GELFOAM SPONGE PARTICLES; ABSORBABLE GELATIN, START DATE: 08MAY2018, STOP DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "PNEUMORACHIS", NOTES: FIRST TACE, 350 UM GELFOAM SPONGE PARTICLES; ABSORBABLE GELATIN, START DATE: 08MAY2018, STOP DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "HEPATIC ABSCESS", NOTES: FIRST TACE, 350 UM GELFOAM SPONGE PARTICLES; THP, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "FEVER", NOTES: FIRST TACE, 30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL; THP, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "SEVERE LIVER DAMAGE", NOTES: FIRST TACE, 30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL; THP, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "COUGH/PNEUMONIA", NOTES: FIRST TACE, 30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL; THP, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "PNEUMORACHIS", NOTES: FIRST TACE, 30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL; THP, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "HEPATIC ABSCESS", NOTES: FIRST TACE, 30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL; IODIZED OIL, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "FEVER", NOTES: FIRST TACE, 8 ML IODIZED OIL; IODIZED OIL, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "SEVERE LIVER DAMAGE", NOTES: FIRST TACE, 8 ML IODIZED OIL; IODIZED OIL, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "COUGH/PNEUMONIA", NOTES: FIRST TACE, 8 ML IODIZED OIL; IODIZED OIL, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "PNEUMORACHIS", NOTES: FIRST TACE, 8 ML IODIZED OIL; IODIZED OIL, START DATE: 08MAY2018, FOR TRANSARTERIAL CHEMOEMBOLIZATION, REACTION(S): "HEPATIC ABSCESS", NOTES: FIRST TACE, 8 ML IODIZED OIL. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 30NOV2018, OUTCOME "FATAL", DESCRIBED AS "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION"; PYREXIA (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 01DEC2018, OUTCOME "FATAL", DESCRIBED AS "FEVER REACHING 39.6 CENTIGRADE"; DYSPNOEA (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 03DEC2018, OUTCOME "FATAL", DESCRIBED AS "DIFFICULTY BREATHING"; SYNCOPE (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 03DEC2018, OUTCOME "FATAL", DESCRIBED AS "FAINTED"; STREPTOCOCCAL BACTERAEMIA (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 03DEC2018, OUTCOME "FATAL", DESCRIBED AS "STREPTOCOCCUS ANGINOSUS FROM HEPATIC PUNCTURE TUBE DRAINAGE WAS POSITIVE"; PORTAL VENOUS GAS (DEATH, MEDICALLY SIGNIFICANT) WITH ONSET 03DEC2018, OUTCOME "FATAL", DESCRIBED AS "LARGE AMOUNT OF GAS IN THE LESIONS AND IN THE PORTAL VEINS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ALANINE AMINOTRANSFERASE (0-40): (01DEC2018) 163 IU/L; ASPARTATE AMINOTRANSFERASE (0-40): (01DEC2018) 249 IU/L; BACTERIAL TEST: (03DEC2018) STREPTOCOCCUS ANGINOSUS FROM HEPATIC PUNCTURE, NOTES: TUBE DRAINAGE WAS POSITIVE; BLOOD BILIRUBIN (1.71-17.1): (01DEC2018) 73 UMOL/L; BODY TEMPERATURE: (01DEC2018) 39.6 CENTIGRADE, NOTES: FEVER BEGAN THE DAY AFTER TACE; COMPUTERISED TOMOGRAM: (03DEC2018) A LARGE AMOUNT OF GAS IN THE LESIONS AND IN THE, NOTES: PORTAL VEINS; GRANULOCYTE COUNT (50-70): (01DEC2018) 98.5 %; WHITE BLOOD CELL COUNT (4-10): (01DEC2018) 14.1 X10 9/L. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, PYREXIA, SYNCOPE, DYSPNOEA, PORTAL VENOUS GAS, STREPTOCOCCAL BACTERAEMIA. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "FEVER REACHING 39.6 CENTIGRADE", "FAINTED", "DIFFICULTY BREATHING", "LARGE AMOUNT OF GAS IN THE LESIONS AND IN THE PORTAL VEINS", "STREPTOCOCCUS ANGINOSUS FROM HEPATIC PUNCTURE TUBE DRAINAGE WAS POSITIVE", "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: WE REPORTED A PATIENT WITH HEPATOCELLULAR CARCINOMA DEVELOPED HPVG FOLLOWING TACE, RESULTING IN A POOR PROGNOSIS. PATIENT WITH A HISTORY OF HEPATITIS B WAS DIAGNOSED WITH PRIMARY HEPATOCELLULAR CARCINOMA. THE PATIENT PREVIOUSLY SUFFERED FROM CHRONIC VIRAL HEPATITIS B WITHOUT CIRRHOSIS. MULTIPHASIC CONTRAST-ENHANCED MAGNETIC RESONANCE IMAGING (MRI) SHOWED A 9.8 CM * 7.9 CM MASS IN THE RIGHT HEPATIC LOBE WITH SEVERAL SMALL LESIONS AND ARTERIAL HYPERVASCULARITY. ALPHA-FETOPROTEIN (AFP) WAS GREATER THAN 3,630 NG/ML. ACCORDING TO EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER (EASL) CLINICAL PRACTICE GUIDELINES, THIS PATIENT WAS IDENTIFIED AS BARCELONA CLINIC LIVER CANCER (BCLC) STAGE B, AND TRANSARTERIAL CHEMOEMBOLIZATION IS THE STANDARD TREATMENT. MAY 8, 2018, THE PATIENT WAS TREATED BY THE FIRST TACE (30 MG THP LOADED BY 100-300 UM DRUG MICRO-BALL, 8 ML IODIZED OIL, 350 UM GELFOAM SPONGE PARTICLES). AFTER ONE DAY FOLLOWING TACE, THE PATIENT DEVELOPED A FEVER, UP TO A MAXIMUM OF 39.3 CENTIGRADE, AND DEVELOPED SEVERE LIVER DAMAGE. THE LABORATORY TEST SHOWED THAT WHITE BLOOD CELL (WBC) WAS 8.5*109/L (NORMAL RANGE: 4*109-10*109/L), NEUTROPHIL GRANULOCYTE (GRAN) 91.4% (NORMAL RANGE: 50-70%), ALANINE AMINOTRANSFERASE (ALT) 2.6 UPPER LIMIT OF NORMAL VALUE (ULN) (NORMAL RANGE: 0-40 U/L), ASPARTATE AMINOTRANSFERASE (AST) 7.9 ULN (NORMAL RANGE: 0-40 U/L), AND TOTAL BILIRUBIN (TBIL) 1.9 ULN (NORMAL RANGE: 1.71-17.1 UMOL/L). THEN HE RECEIVED TREATMENT FOR LIVER PRESERVATION AND OTHER TREATMENTS. ONE MONTH AFTER TACE, ALT, AST AND TBIL RETURNED TO NORMAL RANGE, WHILE WBC WAS 9.2*109/L AND GRAN WAS 82.7%. AT THE SAME TIME, THE ABDOMINAL ENHANCEMENT MRI SHOWED SIGNIFICANT NECROSIS OF THE LESIONS, WITH AFP DROPPING TO 1,708 NG/ML. HOWEVER, FROM JUNE 15, 2018, THE PATIENT EXPERIENCED REPEATED FEVER AND COUGH, EVEN AFTER ANTI-INFECTION TREATMENT. THE BODY TEMPERATURE REACHED A MAXIMUM OF 39 CENTIGRADE. THE CHEST COMPUTED TOMOGRAPHY (CT) SHOWED PNEUMONIA OCCURRED IN THE RIGHT LUNG, AND PNEUMORACHIS WITH IODINE OIL DEPOSITION OCCURRED IN THE TUMOR LESION IN THE RIGHT LOBE OF THE LIVER, WHICH WAS CONSIDERED AS HEPATIC ABSCESS. WE CONTINUED THE ANTI-INFECTION TREATMENT (TAZOBACTAM SODIUM/PIPERACILLIN SODIUM FOR INJECTIO, 4.5 G Q8H FOR 7 DAYS) AND PIGTAIL CATHETER DRAINAGE WAS ADMINISTERED, BUT THE BACTERIA CULTURE WAS NEGATIVE. ON JULY 31, 2018, A SIGNIFICANT REDUCTION IN THE ORIGINAL LESION IN THE RIGHT LOBE OF THE LIVER WAS OBSERVED BY ENHANCED MRI, BUT THE NUMBER OF NEW LESIONS IN THE LIVER INCREASED AND THE AFP ROSE TO MORE THAN 3,630 NG/ML. FROM AUGUST TO NOVEMBER 2018, THE PATIENT RECEIVED THREE MORE TACE (60 MG THP PLUS 20 ML, 8 ML, 7ML IODIZED OIL, RESPECTIVELY). NOVEMBER 28, 2018, ENHANCED MRI SHOWED SIGNIFICANT NECROSIS AND REDUCTION OF THE LESIONS. NOVEMBER 30, THE PATIENT RECEIVED THE FIFTH TACE (60 MG THP PLUS 4 ML IODIZED OIL PLUS 350 UM GELATIN SPONGE PARTICLES). FEVER BEGAN THE DAY AFTER TACE, REACHING 39.6 CENTIGRADE. THE LABORATORY TEST SHOWED THAT WBC WAS 14.1*109/L, GRAN 98.5%, ALT 163 U/L, AST 249 U/L, TBIL 73 UMOL/L. THEN THE PATIENT RECEIVED ANTI- INFECTION AND LIVER PROTECTION TREATMENT. HOWEVER, THREE DAYS AFTER THE FIFTH TACE, THE PATIENT SUDDENLY FAINTED AND HAD DIFFICULTY BREATHING. THE ENHANCING CT SHOWED A LARGE AMOUNT OF GAS IN THE LESIONS AND IN THE PORTAL VEINS. THE BACTERIA CULTURED SHOWED THAT STREPTOCOCCUS ANGINOSUS FROM HEPATIC PUNCTURE TUBE DRAINAGE WAS POSITIVE. ALTHOUGH AFTER ACTIVE TREATMENT, THE PATIENT DIED TWO HOURS AFTER ENTERING THE INTENSIVE CARE UNIT (ICU). NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON INFORMATION PROVIDED, THE REPORTED EVENTS ARE ASSOCIATED WITH ABSORBABLE GELATIN (ABSORBABLE GELATIN). 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 |
|---|---|---|---|---|---|---|---|
| 489244 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Male | Other| D |