ABSORBABLE GELATIN

Description of Event or Problem

ABSORBABLE GELATIN FOR ARTERY EMBOLIZATION/POSTPARTUM HAEMORRHAGE ABNORMAL [OFF LABEL USE], ABSORBABLE GELATIN FOR ARTERY EMBOLIZATION/POSTPARTUM HAEMORRHAGE ABNORMAL [DEVICE USE ISSUE], DID NOT ACHIEVE HEMOSTASIS [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF TOTAL HYSTERECTOMY DUE TO UTERINE NECROSIS AFTER UTERINE ARTERY EMBOLIZATION FOR POSTPARTUM HAEMORRHAGE ABNORMAL", SAITAMA JOURNAL OF OBSTETRICS AND GYNECOLOGY, 2024; VOL:54(1), PGS:28-34. A FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR POSTPARTUM HAEMORRHAGE, THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY AND 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 "ABSORBABLE GELATIN FOR ARTERY EMBOLIZATION/POSTPARTUM HAEMORRHAGE ABNORMAL"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "DID NOT ACHIEVE HEMOSTASIS". THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION. CLINICAL COURSE: FROM AUG2017 TO APR2023, ARTERY EMBOLIZATION WAS PERFORMED FOR POSTPARTUM HAEMORRHAGE ABNORMAL IN HOSPITAL. NBCA (NBCA: N-BUTYL-2-CYANOACRYLATE, COILS, ETC.) WAS USED FOR PATIENT WHO DID NOT ACHIEVE HEMOSTASIS. CAUSALITY FOR "ABSORBABLE GELATIN FOR ARTERY EMBOLIZATION/POSTPARTUM HAEMORRHAGE ABNORMAL" AND "DID NOT ACHIEVE HEMOSTASIS" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). INITIAL CORRECTIVE ACTION: "N/A", COMMENT: THE EVENT THEREPEUTIC PRODUCT INEFFECTIVE IS ASSESSED AS SERIOUS AND ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM) IN THE CONTEXT OF OFF LABEL USE FOR UNAPPROVED INDICATION AND DEVICE USE ISSUE. THE EVENT IS UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THE ROLE OF THE PATIENT'S RELEVANT MEDICAL HISTORY OF POST PARTUM HAEMORRHAGE, ARTERIAL EMBOLIZATION AND TOTAL HYSTERECTOMY AND THEIR POSSIBLE CONTRIBUTION TO THE EVENTS ARE CONSIDERED IN THIS CASE. 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 RAS, ETHICS COMMITTEES, AND INVESTIGATORS, AS APPROPRIATE.