GELFOAM
Report
- Report Number
- 1810189-2023-00144
- Event Type
- Death
- Date Received
- May 5, 2023
- Report Date
- April 25, 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 'PERFORMANCE NOT AS INDICATED IN LABEL' 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]. GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS [PERITONITIS BACTERIAL], DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS [SEPSIS], 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", JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2001; VOL:12 (3), PGS:313-320. A 56-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR HEPATIC NEOPLASM. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING); "HEPATOCELLULAR CARCINOMA" (UNSPECIFIED IF ONGOING), NOTES: DIFFUSE HEPATOCELLULAR CARCINOMA; "TRANSCATHETER OILY CHEMOEMBOLIZATION" (UNSPECIFIED IF ONGOING); "PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE" (UNSPECIFIED IF ONGOING), NOTES: INVASION OF HCC. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), OUTCOME "FATAL" AND ALL DESCRIBED AS "GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION"; PERITONITIS BACTERIAL (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), SEPSIS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), OUTCOME "FATAL" AND ALL DESCRIBED AS "DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS"; LIVER ABSCESS (HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED", 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 RESULT; HISTOLOGY: UNKNOWN RESULT; BILARY STATUS: TYPE 2 BILIARY ABNORMALITY; 6, NOTES: UNIT: CM; LIVER FUNCTION TEST: UNKNOWN RESULT. 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: "DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS", "LIVER ABSCESS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: PATIENT DIED WITHIN 4 MONTHS OF HOSPITAL ADMISSION. PATIENT SUCCESSFULLY RECOVERED FROM THE LIVER ABSCESS WITH PARENTERAL ANTIBIOTICS AND PCD. HOWEVER, THE PATIENT EVENTUALLY DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 30NOV2023 FOR ABSORBABLE GELATIN: CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' 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. UDI: (B)(4). NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO ALLOW APPROPRIATE REPORTING TO HEALTH AUTHORITIES. FOLLOW-UP (30NOV2023): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: THE EVENTS OFF LABEL USE, DEVICE USE ISSUES AND LIVER ABSCESS, BACTERIAL PERITONITIS WITH SEPSIS 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 FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.
EVENT VERBATIM [PREFERRED TERM] . GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS [PERITONITIS BACTERIAL], DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS [SEPSIS], 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", JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2001; VOL:12 (3), PGS:313-320. A 56-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR HEPATIC NEOPLASM. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING); "HEPATOCELLULAR CARCINOMA" (UNSPECIFIED IF ONGOING), NOTES: DIFFUSE HEPATOCELLULAR CARCINOMA; "TRANSCATHETER OILY CHEMOEMBOLIZATION" (UNSPECIFIED IF ONGOING); "PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE" (UNSPECIFIED IF ONGOING), NOTES: INVASION OF HCC. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), OUTCOME "FATAL" AND ALL DESCRIBED AS "GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION"; PERITONITIS BACTERIAL (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), SEPSIS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), OUTCOME "FATAL" AND ALL DESCRIBED AS "DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS"; LIVER ABSCESS (HOSPITALIZATION, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED", 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 RESULT; HISTOLOGY: UNKNOWN RESULT; BILARY STATUS: TYPE 2 BILIARY ABNORMALITY; 6, NOTES: UNIT: CM; LIVER FUNCTION TEST: UNKNOWN RESULT. 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: "DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS", "LIVER ABSCESS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: PATIENT DIED WITHIN 4 MONTHS OF HOSPITAL ADMISSION. PATIENT SUCCESSFULLY RECOVERED FROM THE LIVER ABSCESS WITH PARENTERAL ANTIBIOTICS AND PCD. HOWEVER, THE PATIENT EVENTUALLY DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE EVENTS OFF LABEL USE, DEVICE USE ISSUES AND LIVER ABSCESS, BACTERIAL PERITONITIS WITH SEPSIS 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.
EVENT VERBATIM [PREFERRED TERM] GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS [PERITONITIS BACTERIAL], DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS [SEPSIS], 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", JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2001; VOL:12 (3), PGS:313-320. A 56-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR HEPATIC NEOPLASM. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING); "HEPATOCELLULAR CARCINOMA" (UNSPECIFIED IF ONGOING), NOTES: DIFFUSE HEPATOCELLULAR CARCINOMA; "TRANSCATHETER OILY CHEMOEMBOLIZATION" (UNSPECIFIED IF ONGOING); "PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE" (UNSPECIFIED IF ONGOING), NOTES: INVASION OF HCC. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), OUTCOME "FATAL" AND ALL DESCRIBED AS "GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION"; PERITONITIS BACTERIAL (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), SEPSIS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED), OUTCOME "FATAL" AND ALL DESCRIBED AS "DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS"; LIVER ABSCESS (HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED", 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 RESULT; HISTOLOGY: UNKNOWN RESULT; BILARY STATUS: TYPE 2 BILIARY ABNORMALITY; 6, NOTES: UNIT: CM; LIVER FUNCTION TEST: UNKNOWN RESULT. 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: "DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS", "LIVER ABSCESS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: PATIENT DIED WITHIN 4 MONTHS OF HOSPITAL ADMISSION. PATIENT SUCCESSFULLY RECOVERED FROM THE LIVER ABSCESS WITH PARENTERAL ANTIBIOTICS AND PCD. HOWEVER, THE PATIENT EVENTUALLY DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO ALLOW APPROPRIATE REPORTING TO HEALTH AUTHORITIES., COMMENT: THE EVENTS OFF LABEL USE, DEVICE USE ISSUES AND LIVER ABSCESS, BACTERIAL PERITONITIS WITH SEPSIS 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 FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475228 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Hospitalization| R| D| O |