GELFOAM
Report
- Report Number
- 1810189-2023-00087
- Event Type
- Death
- Date Received
- April 28, 2023
- Report Date
- April 12, 2023
- 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
- PHYSICIAN
- Health Professional
- Yes
Narratives
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: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], UNCONTROLLABLE ACUTE HEPATIC FAILURE [ACUTE HEPATIC FAILURE], GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE [LIVER ABSCESS], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LIVER ABSCESS AFTER TRANSCATHETER OILY CHEMOEMBOLIZATION FOR HEPATIC TUMORS: INCIDENCE, PREDISPOSING FACTORS, AND CLINICAL OUTCOME", J VASC INTERV RADIOL, 2001; VOL:12, PGS:313-20. PATIENT(S) (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR TRANSCATHETER ARTERIAL CHEMOEMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION"; LIVER ABSCESS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE". ADDITIONAL DETAIL INFORMATION: IT IS REPORTED THAT GELFOAM PARTICLES WERE APPLIED IN A CASE SERIES OF LIVER ABSCESS FORMATION AFTER TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) FOR LIVER TUMORS, WHICH INDICATING THAT THE USE OF GELFOAM MAY INCREASE THE RISK OF LIVER ABSCESS FORMATION FOR PATIENTS WITH PORTAL VEIN TUMOR THROMBUS AFTER TACE. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (25APR2023): THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LIVER ABSCESS AFTER TRANSCATHETER OILY CHEMOEMBOLIZATION FOR HEPATIC TUMORS: INCIDENCE, PREDISPOSING FACTORS, AND CLINICAL OUTCOME", JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2001; VOL:12 (3), PGS:313-320. THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION. A 43-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR TRANSCATHETER ARTERIAL CHEMOEMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING); "HCC (MASSIVE)" (UNSPECIFIED IF ONGOING), NOTES: SIZE 15 CM; "PORTAL VEIN OCCLUSION" (UNSPECIFIED IF ONGOING), NOTES: RIGHT POSTERIOR; "TRANSCATHETER OILY CHEMOEMBOLIZATION" (UNSPECIFIED IF ONGOING), NOTES: RIGHT HEPATIC ARTERY. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION"; ACUTE HEPATIC FAILURE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "UNCONTROLLABLE ACUTE HEPATIC FAILURE"; LIVER ABSCESS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: CULTURE: UNKNOWN RESULTS; HISTOLOGY: UNKNOWN RESULTS; BILARY STATUS: INTACT; LIVER FUNCTION TEST: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF LIVER ABSCESS. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "UNCONTROLLABLE ACUTE HEPATIC FAILURE". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE DETAILS: FOUR PATIENTS (PATIENTS 2, 7, 8, AND 11) DIED WITHIN 4 MONTHS OF HOSPITAL ADMISSION. UNCONTROLLABLE ACUTE HEPATIC FAILURE WAS THE CAUSE OF DEATH IN PATIENT 2, WHO DIED 61 DAYS AFTER THE DIAGNOSIS OF LIVER ABSCESS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6) 2023 FOR ABSORBABLE GELATIN: 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. THE REPORTER CONSIDERED "INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION", "UNCONTROLLABLE ACUTE HEPATIC FAILURE" AND "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE" ASSOCIATED TO ABSORBABLE GELATIN. CAUSALITY FOR "INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION", "UNCONTROLLABLE ACUTE HEPATIC FAILURE" AND "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (14DEC2023): 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: THE EVENTS OF OFF LABEL USE, DEVICE USE ISSUE, LIVER ABSCESS, ACUTE HEPATIC FAILURE ARE ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. 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: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], UNCONTROLLABLE ACUTE HEPATIC FAILURE [ACUTE HEPATIC FAILURE], GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE [LIVER ABSCESS], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LIVER ABSCESS AFTER TRANSCATHETER OILY CHEMOEMBOLIZATION FOR HEPATIC TUMORS: INCIDENCE, PREDISPOSING FACTORS, AND CLINICAL OUTCOME", J VASC INTERV RADIOL, 2001; VOL:12, PGS:313-20. PATIENT(S) (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR TRANSCATHETER ARTERIAL CHEMOEMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION"; LIVER ABSCESS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE". ADDITIONAL DETAIL INFORMATION: IT IS REPORTED THAT GELFOAM PARTICLES WERE APPLIED IN A CASE SERIES OF LIVER ABSCESS FORMATION AFTER TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) FOR LIVER TUMORS, WHICH INDICATING THAT THE USE OF GELFOAM MAY INCREASE THE RISK OF LIVER ABSCESS FORMATION FOR PATIENTS WITH PORTAL VEIN TUMOR THROMBUS AFTER TACE. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (25APR2023): THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LIVER ABSCESS AFTER TRANSCATHETER OILY CHEMOEMBOLIZATION FOR HEPATIC TUMORS: INCIDENCE, PREDISPOSING FACTORS, AND CLINICAL OUTCOME", JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2001; VOL:12 (3), PGS:313-320. THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION. A 43-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR TRANSCATHETER ARTERIAL CHEMOEMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING); "HCC (MASSIVE)" (UNSPECIFIED IF ONGOING), NOTES: SIZE 15 CM; "PORTAL VEIN OCCLUSION" (UNSPECIFIED IF ONGOING), NOTES: RIGHT POSTERIOR; "TRANSCATHETER OILY CHEMOEMBOLIZATION" (UNSPECIFIED IF ONGOING), NOTES: RIGHT HEPATIC ARTERY. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: ACUTE HEPATIC FAILURE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "UNCONTROLLABLE ACUTE HEPATIC FAILURE"; LIVER ABSCESS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE"; OFF LABEL USE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: CULTURE: UNKNOWN RESULTS; HISTOLOGY: UNKNOWN RESULTS; BILARY STATUS: INTACT; LIVER FUNCTION TEST: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF LIVER ABSCESS. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "UNCONTROLLABLE ACUTE HEPATIC FAILURE". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE DETAILS: FOUR PATIENTS (PATIENTS 2, 7, 8, AND 11) DIED WITHIN 4 MONTHS OF HOSPITAL ADMISSION. UNCONTROLLABLE ACUTE HEPATIC FAILURE WAS THE CAUSE OF DEATH IN PATIENT 2, WHO DIED 61 DAYS AFTER THE DIAGNOSIS OF LIVER ABSCESS. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE EVENTS OF OFF LABEL USE, DEVICE USE ISSUE, LIVER ABSCESS, ACUTE HEPATIC FAILURE ARE ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. 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: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE [LIVER ABSCESS]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LIVER ABSCESS AFTER TRANSCATHETER OILY CHEMOEMBOLIZATION FOR HEPATIC TUMORS: INCIDENCE, PREDISPOSING FACTORS, AND CLINICAL OUTCOME", J VASC INTERV RADIOL, 2001; VOL:12, PGS:313-20. PATIENT(S) (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR TRANSCATHETER ARTERIAL CHEMOEMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION"; LIVER ABSCESS (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE". ADDITIONAL DETAIL INFORMATION: IT IS REPORTED THAT GELFOAM PARTICLES WERE APPLIED IN A CASE SERIES OF LIVER ABSCESS FORMATION AFTER TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) FOR LIVER TUMORS, WHICH INDICATING THAT THE USE OF GELFOAM MAY INCREASE THE RISK OF LIVER ABSCESS FORMATION FOR PATIENTS WITH PORTAL VEIN TUMOR THROMBUS AFTER TACE. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE EVENTS OF OFF LABEL USE AND LIVER ABSCESS ARE ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. 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 |
|---|---|---|---|---|---|---|---|
| 476293 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Male | Death| O| R| H |