ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2023-00079
- Event Type
- Injury
- Date Received
- April 27, 2023
- Date of Event
- May 8, 2018
- Report Date
- April 12, 2023
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON [05DEC2023] FOR [ABSORBABLE GELATIN]: UDI: (B)(4). 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. INITIAL CORRECTIVE ACTION: N/A. FURTHER INVESTIGATION: N/A.
EVENT VERBATIM [PREFERRED TERM] INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], DEVELOPED A FEVER, UP TO A MAXIMUM OF 39.3 CENTIGRADE/ REPEATED FEVER/ BODY TEMPERATURE REACHED A MAXIMUM OF 39 CENTIGRADE [PYREXIA], SEVERE LIVER DAMAGE [LIVER INJURY], COUGH/PNEUMONIA OCCURRED IN THE RIGHT LUNG [PNEUMONIA], PNEUMORACHIS WITH IODINE OIL DEPOSITION OCCURRED IN THE TUMOR LESION IN THE RIGHT LOBE OF THE LIVER, WHICH WAS CONSIDERED AS HEPATIC ABSCESS [PNEUMORRHACHIS], PNEUMORACHIS WITH IODINE OIL DEPOSITION OCCURRED IN THE TUMOR LESION IN THE RIGHT LOBE OF THE LIVER, WHICH WAS CONSIDERED AS HEPATIC ABSCESS [LIVER ABSCESS], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP 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), FROM (B)(6) 2018 AT 350 UM FOR THERAPEUTIC EMBOLISATION; TRIHEXYPHENIDYL HYDROCHLORIDE (THP), SINCE 08MAY2018 (BATCH/LOT NUMBER: UNKNOWN) AT 30 MG (LOADED BY 100-300 UM DRUG MICRO-BALL) FOR THERAPEUTIC EMBOLISATION; IODIZED OIL (IODIZED OIL), SINCE (B)(6) 2018 (BATCH/LOT NUMBER: UNKNOWN) AT 8 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. 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) ALL WITH ONSET (B)(6) 2018, OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION"; PYREXIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT) WITH ONSET (B)(6) 2018, OUTCOME "UNKNOWN", DESCRIBED AS "DEVELOPED A FEVER, UP TO A MAXIMUM OF 39.3 CENTIGRADE/ REPEATED FEVER/ BODY TEMPERATURE REACHED A MAXIMUM OF 39 CENTIGRADE"; LIVER INJURY (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT) WITH ONSET (B)(6) 2018, OUTCOME "UNKNOWN", DESCRIBED AS "SEVERE LIVER DAMAGE"; PNEUMONIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT) WITH ONSET (B)(6) 2018, OUTCOME "UNKNOWN", DESCRIBED AS "COUGH/PNEUMONIA OCCURRED IN THE RIGHT LUNG"; PNEUMORRHACHIS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), LIVER ABSCESS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT) ALL WITH ONSET (B)(6) 2018, OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "PNEUMORACHIS WITH IODINE OIL DEPOSITION OCCURRED IN THE TUMOR LESION IN THE RIGHT LOBE OF THE LIVER, WHICH WAS CONSIDERED AS HEPATIC ABSCESS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ALANINE AMINOTRANSFERASE (0-40): ((B)(6) 2018) 2.6 UPPER LIMIT OF NORMAL VALUE (ULN); ((B)(6) 2018) RETURNED TO NORMAL RANGE; ASPARTATE AMINOTRANSFERASE (0-40): (09MAY2018) 7.9 ULN; ((B)(6) 2018) RETURNED TO NORMAL RANGE; BACTERIAL TEST: (UNSPECIFIED DATE) NEGATIVE; BLOOD BILIRUBIN (1.71-17.1): ((B)(6) 2018) 1.9 ULN; ((B)(6) 2018) RETURNED TO NORMAL RANGE; BODY TEMPERATURE: ((B)(6) 2018) 39.3 CENTIGRADE; ((B)(6) 2018) 39 CENTIGRADE; COMPUTERISED TOMOGRAM THORAX: ((B)(6) 2018) SHOWED PNEUMONIA OCCURRED IN THE RIGHT LUNG, AND, NOTES: PNEUMORACHIS WITH IODINE OIL DEPOSITION OCCURRED IN THE TUMOR LESION IN THE RIGHT LOBE OF THE LIVER, WHICH WAS CONSIDERED AS HEPATIC ABSCESS; GRANULOCYTE COUNT (50-70): ((B)(6) 2018) 91.4 %; ((B)(6) 2018) 82.7 %; MAGNETIC RESONANCE IMAGING: (08JUN2018) SIGNIFICANT NECROSIS OF THE LESIONS; ((B)(6) 2018) A SIGNIFICANT REDUCTION, NOTES: IN THE ORIGINAL LESION IN THE RIGHT LOBE OF THE LIVER WAS OBSERVED; WHITE BLOOD CELL COUNT (4-10): ((B)(6) 2018) 8.5 X10 9/L; ((B)(6) 2018) 9.2 X10 9/L. THE ACTION TAKEN FOR TRIHEXYPHENIDYL HYDROCHLORIDE AND IODIZED OIL WAS UNKNOWN. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS TEMPORARILY WITHDRAWN ON (B)(6) 2018. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, DEVICE USE ISSUE, PYREXIA, LIVER INJURY, PNEUMONIA, PNEUMORRHACHIS, LIVER ABSCESS. CAUSALITY FOR "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION", "DEVELOPED A FEVER, UP TO A MAXIMUM OF 39.3 CENTIGRADE/ REPEATED FEVER/ BODY TEMPERATURE REACHED A MAXIMUM OF 39 CENTIGRADE", "SEVERE LIVER DAMAGE", "COUGH/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" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). 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. (B)(6) 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 (B)(6) 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 (B)(6) 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. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON [05DEC2023] FOR [ABSORBABLE GELATIN]: UDI: (B)(4). 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. INITIAL CORRECTIVE ACTION: N/A. FURTHER INVESTIGATION: N/A. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (05DEC2023): 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: CONSIDERING THE PLAUSIBLE DRUG-EVENT TEMPORAL ASSOCIATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT GELFOAM TO THE REPORTED EVENTS CANNOT BE EXCLUDED. CASE WILL BE REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION. 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], DEVELOPED A FEVER, UP TO A MAXIMUM OF 39.3 CENTIGRADE/ REPEATED FEVER/ BODY . TEMPERATURE REACHED A MAXIMUM OF 39 CENTIGRADE [PYREXIA], SEVERE LIVER DAMAGE [LIVER INJURY], COUGH/PNEUMONIA OCCURRED IN THE RIGHT LUNG [PNEUMONIA], PNEUMORACHIS WITH IODINE OIL DEPOSITION OCCURRED IN THE TUMOR LESION IN THE RIGHT LOBE OF THE LIVER, WHICH WAS CONSIDERED AS HEPATIC ABSCESS [PNEUMORRHACHIS], PNEUMORACHIS WITH IODINE OIL DEPOSITION OCCURRED IN THE TUMOR LESION IN THE RIGHT LOBE OF THE LIVER, WHICH WAS CONSIDERED AS HEPATIC ABSCESS [LIVER ABSCESS], , 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), FROM (B)(6)2018 TO (B)(6) 2018 AT 350 UM FOR THERAPEUTIC EMBOLISATION; TRIHEXYPHENIDYL HYDROCHLORIDE (THP), SINCE (B)(6) 2018 (BATCH/LOT NUMBER: UNKNOWN) AT 30 MG (LOADED BY 100-300 UM DRUG MICRO-BALL) FOR THERAPEUTIC EMBOLISATION; IODIZED OIL (IODIZED OIL), SINCE (B)(6) 2018 (BATCH/LOT NUMBER: UNKNOWN) AT 8 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. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT) WITH ONSET (B)(6) 2018, OUTCOME "UNKNOWN", DESCRIBED AS "INDICATION: TRANSARTERIAL CHEMOEMBOLIZATION"; PYREXIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT) WITH ONSET (B)(6) 2018, OUTCOME "UNKNOWN", DESCRIBED AS "DEVELOPED A FEVER, UP TO A MAXIMUM OF 39.3 CENTIGRADE/ REPEATED FEVER/ BODY TEMPERATURE REACHED A MAXIMUM OF 39 CENTIGRADE"; LIVER INJURY (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT) WITH ONSET (B)(6) 2018, OUTCOME "UNKNOWN", DESCRIBED AS "SEVERE LIVER DAMAGE"; PNEUMONIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT) WITH ONSET (B)(6) 2018, OUTCOME "UNKNOWN", DESCRIBED AS "COUGH/PNEUMONIA OCCURRED IN THE RIGHT LUNG"; PNEUMORRHACHIS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), LIVER ABSCESS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT) ALL WITH ONSET (B)(6) 2018, OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "PNEUMORACHIS WITH IODINE OIL DEPOSITION OCCURRED IN THE TUMOR LESION IN THE RIGHT LOBE OF THE LIVER, WHICH WAS CONSIDERED AS HEPATIC ABSCESS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ALANINE AMINOTRANSFERASE (0-40): ((B)(6)2018) 2.6 UPPER LIMIT OF NORMAL VALUE (ULN); ((B)(6) 2018) RETURNED TO NORMAL RANGE; ASPARTATE AMINOTRANSFERASE (0-40): ((B)(6) 2018) 7.9 ULN; ((B)(6) 2018) RETURNED TO NORMAL RANGE; BACTERIAL TEST: (UNSPECIFIED DATE) NEGATIVE; BLOOD BILIRUBIN (1.71-17.1): ((B)(6) 2018) 1.9 ULN; ((B)(6) 2018) RETURNED TO NORMAL RANGE; BODY TEMPERATURE: ((B)(6) 2018) 39.3 CENTIGRADE; ((B)(6) 2018) 39 CENTIGRADE; COMPUTERISED TOMOGRAM THORAX: ((B)(6) 2018) SHOWED PNEUMONIA OCCURRED IN THE RIGHT LUNG, AND, NOTES: PNEUMORACHIS WITH IODINE OIL DEPOSITION OCCURRED IN THE TUMOR LESION IN THE RIGHT LOBE OF THE LIVER, WHICH WAS CONSIDERED AS HEPATIC ABSCESS; GRANULOCYTE COUNT (50-70): ((B)(6) 2018) 91.4 %; ((B)(6) 2018) 82.7 %; MAGNETIC RESONANCE IMAGING: ((B)(6) 2018) SIGNIFICANT NECROSIS OF THE LESIONS; ((B)(6) 2018) A SIGNIFICANT REDUCTION, NOTES: IN THE ORIGINAL LESION IN THE RIGHT LOBE OF THE LIVER WAS OBSERVED; WHITE BLOOD CELL COUNT (4-10): ((B)(6) 2018) 8.5 X10 9/L; ((B)(6) 2018) 9.2 X10 9/L. THE ACTION TAKEN FOR TRIHEXYPHENIDYL HYDROCHLORIDE AND IODIZED OIL WAS UNKNOWN. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS TEMPORARILY WITHDRAWN ON (B)(6) 2018. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, PYREXIA, LIVER INJURY, PNEUMONIA, PNEUMORRHACHIS, LIVER ABSCESS. 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. (B)(6) 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 (B)(6) 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. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: CONSIDERING THE PLAUSIBLE DRUG-EVENT TEMPORAL ASSOCIATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT GELFOAM TO THE REPORTED EVENTS CANNOT BE EXCLUDED. CASE WILL BE REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION. 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 |
|---|---|---|---|---|---|---|---|
| 1626038 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Male | Required Intervention| O |