ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2025-00024
- Event Type
- Injury
- Date Received
- September 29, 2025
- Report Date
- September 20, 2025
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' 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. MANUFACTURING SITE INVESTIGATION: AN ADVERSE EVENT COMPLAINT WAS RECEIVED FOR AN UNKNOWN LOT OF GELFOAM. REVIEW OF COMPLAINTS FOR GELFOAM ABSORBABLE MATERIAL RECEIVED WITHIN 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER WERE IDENTIFIED. EXISTING PROCESS CONTROLS, SUCH AS USE OF A SPECIFIC VALIDATED FORMULATION RECIPE AND AUTOMATIC RECORDING OF ALL WEIGHTS AND IDENTITIES OF RAW MATERIALS, DOCUMENTATION AND VERIFICATION OF CRITICAL FORMULATION, PROCESSING, AND STERILIZATION STEPS, AND FINAL RELEASE TESTING OF EACH BATCH TO ASSURE THAT IT MEETS ALL INTERNAL TARGETS AND REGISTERED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION WERE REVIEWED AS A PART OF THIS INVESTIGATION. NO TRENDS WERE NOTED THAT WOULD REQUIRE ADDITIONAL INVESTIGATION. NO RETURNED COMPLAINT SAMPLE WAS RECEIVED.
INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' 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] ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM) [OFF LABEL USE], ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM) [DEVICE USE ISSUE], PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "ACQUIRED UTERINE ARTERIOVENOUS MALFORMATION: EFFICACY OF THE USE OF ABSORBABLE HAEMOSTATIC GELATIN IN UTERINE ARTERY EMBOLISATION", EMERGENCY RADIOLOGY, 2025; DOI:10.1007/S10140-025-02386-7. A 33-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), INTRA-ARTERIAL FOR UTERINE ARTERY EMBOLISATION, ARTERIOVENOUS MALFORMATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "UTERINE ARTERY EMBOLISATION" (UNSPECIFIED IF ONGOING); "SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM)" (UNSPECIFIED IF ONGOING); "ACUTE UROGENITAL BLEEDING" (UNSPECIFIED IF ONGOING). 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), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM)"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ANGIOGRAM: UAVM WITH EARLY VENOUS FILLING, NOTES: SELECTIVE LEFT UTERINE ANGIOGRAM; REDUCED CONTRAST FILLING OF VASCULAR ABNORMALITY, NOTES: POST-GELATIN EMBOLIZATION ANGIOGRAM; RECURRENT UAVM, NOTES: REPEATED SELECTIVE UTERINE ANGIOGRAM; ULTRASOUND UTERUS: ACUTE UROGENITAL BLEEDING DUE TO UAVM. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION. CAUSALITY FOR "ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM)" AND "PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). INFORMATION FROM LITERATURE ARTICLE: ABSTRACT: PURPOSE: TO EVALUATE THE EFFICACY AND COMPLICATIONS OF ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM). METHODS: ALL THE ADULT FEMALE PATIENTS WHO HAD ACUTE UROGENITAL BLEEDING DUE TO UAVM CONFIRMED ON ULTRASOUND AND RECEIVED UTERINE ARTERY EMBOLISATION (UAE) FOR UAVM IN A TERTIARY INSTITUTION BETWEEN (B)(6) 2024 WERE INCLUDED. PATIENTS WHO HAD UAE FOR OTHER CAUSES WERE EXCLUDED. CAUSES OF UAVM, EMBOLIC AGENTS USED, PROCEDURAL SUCCESS, RECURRENT GENITAL BLEEDING, AND COMPLICATIONS LIKE PULMONARY EMBOLISM AND GROIN BLEEDING WERE RECORDED. RESULTS: SEVEN FEMALE PATIENTS (MEAN AGE: 34 YEARS) WITH 8 UAE PROCEDURES WERE INCLUDED, WITH THREE POSTPARTUM AND FOUR AFTER MISCARRIAGES. THE MEAN LENGTH OF FOLLOW-UP AFTER UAE WAS 50 MONTHS. ABSORBABLE GELATIN WAS USED IN SIX PATIENTS, AND POLYVINYL ALCOHOL (PVA) PARTICLES WERE USED IN ONE PATIENT. 5/6 PATIENTS (83.3%) HAD SUCCESSFUL UAE WITH ABSORBABLE HAEMOSTATIC GELATIN. THERE WERE NO PROCEDURE-RELATED COMPLICATIONS, INCLUDING PULMONARY EMBOLISM AND UTERINE INFARCTS. ONLY ONE PATIENT REQUIRED A REPEATED UAE 33 DAYS LATER FOR RECURRENT VAGINAL BLEEDING, WHICH REQUIRED SODIUM TETRADECYL SULPHATE INJECTION AND MICROCOILS DURING EMBOLISATION. CONCLUSION: ACQUIRED UAVM IS VERY RARE BUT LIFE-THREATENING. ABSORBABLE HAEMOSTATIC GELATIN, A TEMPORARY EMBOLIC AGENT, APPEARS SAFE AND EFFECTIVE IN TREATING UAVM WITH UTERINE PRESERVATION. IT ELIMINATES THE POTENTIAL RISK OF UTERINE INFARCTION THAT MIGHT OCCUR WITH PERMANENT EMBOLIC AGENTS. A 33-YEAR-OLD FEMALE WITH SIGNIFICANT BLEEDING POST DILATION AND CURETTAGE (D&C) FOR MISCARRIAGE. SELECTIVE LEFT UTERINE ANGIOGRAM DEMONSTRATED UAVM WITH EARLY VENOUS FILLING. POST-GELATIN EMBOLISATION ANGIOGRAM SHOWED MUCH REDUCED CONTRAST FILLING (B) OF THE VASCULAR ABNORMALITY. THIS PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING. THE REPEATED SELECTIVE UTERINE ANGIOGRAM CONFIRMED RECURRENT UAVM. THIS WAS SUCCESSFULLY EMBOLIZED WITH MICRO-COILS AND SODIUM TETRADECYL SULPHATE. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 10NOV2025 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' 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. ADDITIONAL PRODUCT QUALITY INFORMATION: "INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' 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. " PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 17NOV2025 FOR ABSORBABLE GELATIN: MANUFACTURING SITE INVESTIGATION: AN ADVERSE EVENT COMPLAINT WAS RECEIVED FOR AN UNKNOWN LOT OF GELFOAM. REVIEW OF COMPLAINTS FOR GELFOAM ABSORBABLE MATERIAL RECEIVED WITHIN 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER WERE IDENTIFIED. EXISTING PROCESS CONTROLS, SUCH AS USE OF A SPECIFIC VALIDATED FORMULATION RECIPE AND AUTOMATIC RECORDING OF ALL WEIGHTS AND IDENTITIES OF RAW MATERIALS, DOCUMENTATION AND VERIFICATION OF CRITICAL FORMULATION, PROCESSING, AND STERILIZATION STEPS, AND FINAL RELEASE TESTING OF EACH BATCH TO ASSURE THAT IT MEETS ALL INTERNAL TARGETS AND REGISTERED SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION WERE REVIEWED AS A PART OF THIS INVESTIGATION. NO TRENDS WERE NOTED THAT WOULD REQUIRE ADDITIONAL INVESTIGATION. NO RETURNED COMPLAINT SAMPLE WAS RECEIVED. FOLLOW-UP (10NOV2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. FOLLOW-UP (17NOV2025 ): THIS IS A LITERATURE FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: DRUG EFFICACY MAY VARY FROM PERSON TO PERSON AND IS SUBJECT TO MULTIPLE FACTORS INCLUDING PHARMACOKINETICS, SEVERITY OF DISEASE AND PATIENT GENERAL HEALTH CONDITION. THE POSSIBILITY OF AN ASSOCIATION BETWEEN THE EVENTS DEVICE USE ISSUE, THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION IN THE CONTEXT OF OFF LABEL USE AND THE SUSPECT PRODUCT ABSORBABLE GELATIN CANNOT BE FULLY EXCLUDED. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
EVENT [PREFERRED TERM] ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM) [OFF LABEL USE], ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM) [DEVICE USE ISSUE], PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "ACQUIRED UTERINE ARTERIOVENOUS MALFORMATION: EFFICACY OF THE USE OF ABSORBABLE HAEMOSTATIC GELATIN IN UTERINE ARTERY EMBOLISATION", EMERGENCY RADIOLOGY, 2025; DOI:10.1007/S10140-025-02386-7. A 33-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), INTRA-ARTERIAL FOR UTERINE ARTERY EMBOLISATION, ARTERIOVENOUS MALFORMATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "UTERINE ARTERY EMBOLISATION" (UNSPECIFIED IF ONGOING); "SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM)" (UNSPECIFIED IF ONGOING); "ACUTE UROGENITAL BLEEDING" (UNSPECIFIED IF ONGOING). 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), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM)"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ANGIOGRAM: UAVM WITH EARLY VENOUS FILLING, NOTES: SELECTIVE LEFT UTERINE ANGIOGRAM; REDUCED CONTRAST FILLING OF VASCULAR ABNORMALITY, NOTES: POST-GELATIN EMBOLIZATION ANGIOGRAM; RECURRENT UAVM, NOTES: REPEATED SELECTIVE UTERINE ANGIOGRAM; ULTRASOUND UTERUS: ACUTE UROGENITAL BLEEDING DUE TO UAVM. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION. CAUSALITY FOR "ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM)" AND "PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). INFOMATION FROM LITERATURE ARTICLE: ABSTRACT: PURPOSE: TO EVALUATE THE EFFICACY AND COMPLICATIONS OF ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM). METHODS: ALL THE ADULT FEMALE PATIENTS WHO HAD ACUTE UROGENITAL BLEEDING DUE TO UAVM CONFIRMED ON ULTRASOUND AND RECEIVED UTERINE ARTERY EMBOLISATION (UAE) FOR UAVM IN A TERTIARY INSTITUTION BETWEEN JANUARY 2000 AND OCTOBER 2024 WERE INCLUDED. PATIENTS WHO HAD UAE FOR OTHER CAUSES WERE EXCLUDED. CAUSES OF UAVM, EMBOLIC AGENTS USED, PROCEDURAL SUCCESS, RECURRENT GENITAL BLEEDING, AND COMPLICATIONS LIKE PULMONARY EMBOLISM AND GROIN BLEEDING WERE RECORDED. RESULTS: SEVEN FEMALE PATIENTS (MEAN AGE: 34 YEARS) WITH 8 UAE PROCEDURES WERE INCLUDED, WITH THREE POSTPARTUM AND FOUR AFTER MISCARRIAGES. THE MEAN LENGTH OF FOLLOW-UP AFTER UAE WAS 50 MONTHS. ABSORBABLE GELATIN WAS USED IN SIX PATIENTS, AND POLYVINYL ALCOHOL (PVA) PARTICLES WERE USED IN ONE PATIENT. 5/6 PATIENTS (83.3%) HAD SUCCESSFUL UAE WITH ABSORBABLE HAEMOSTATIC GELATIN. THERE WERE NO PROCEDURE-RELATED COMPLICATIONS, INCLUDING PULMONARY EMBOLISM AND UTERINE INFARCTS. ONLY ONE PATIENT REQUIRED A REPEATED UAE 33 DAYS LATER FOR RECURRENT VAGINAL BLEEDING, WHICH REQUIRED SODIUM TETRADECYL SULPHATE INJECTION AND MICROCOILS DURING EMBOLISATION. CONCLUSION: ACQUIRED UAVM IS VERY RARE BUT LIFE-THREATENING. ABSORBABLE HAEMOSTATIC GELATIN, A TEMPORARY EMBOLIC AGENT, APPEARS SAFE AND EFFECTIVE IN TREATING UAVM WITH UTERINE PRESERVATION. IT ELIMINATES THE POTENTIAL RISK OF UTERINE INFARCTION THAT MIGHT OCCUR WITH PERMANENT EMBOLIC AGENTS. A 33-YEAR-OLD FEMALE WITH SIGNIFICANT BLEEDING POST DILATION AND CURETTAGE (D&C) FOR MISCARRIAGE. SELECTIVE LEFT UTERINE ANGIOGRAM DEMONSTRATED UAVM WITH EARLY VENOUS FILLING. POST-GELATIN EMBOLISATION ANGIOGRAM SHOWED MUCH REDUCED CONTRAST FILLING (B) OF THE VASCULAR ABNORMALITY. THIS PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING. THE REPEATED SELECTIVE UTERINE ANGIOGRAM CONFIRMED RECURRENT UAVM. THIS WAS SUCCESSFULLY EMBOLIZED WITH MICRO-COILS AND SODIUM TETRADECYL SULPHATE., COMMENT: DRUG EFFICACY MAY VARY FROM PERSON TO PERSON AND IS SUBJECT TO MULTIPLE FACTORS INCLUDING PHARMACOKINETICS, SEVERITY OF DISEASE AND PATIENT GENERAL HEALTH CONDITION. THE POSSIBILITY OF AN ASSOCIATION BETWEEN THE EVENT THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION IN THE CONTEXT OF OFF LABEL USE AND THE SUSPECT PRODUCT ABSORBABLE GELATIN CANNOT BE FULLY EXCLUDED. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
EVENT VERBATIM [PREFERRED TERM] ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM) [OFF LABEL USE], ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM) [DEVICE USE ISSUE], PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "ACQUIRED UTERINE ARTERIOVENOUS MALFORMATION: EFFICACY OF THE USE OF ABSORBABLE HAEMOSTATIC GELATIN IN UTERINE ARTERY EMBOLISATION", EMERGENCY RADIOLOGY, 2025; DOI:10.1007/S10140-025-02386-7. A 33-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), INTRA-ARTERIAL FOR UTERINE ARTERY EMBOLISATION, ARTERIOVENOUS MALFORMATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "UTERINE ARTERY EMBOLISATION" (UNSPECIFIED IF ONGOING); "SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM)" (UNSPECIFIED IF ONGOING); "ACUTE UROGENITAL BLEEDING" (UNSPECIFIED IF ONGOING). 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), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM)"; THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ANGIOGRAM: UAVM WITH EARLY VENOUS FILLING, NOTES: SELECTIVE LEFT UTERINE ANGIOGRAM; REDUCED CONTRAST FILLING OF VASCULAR ABNORMALITY, NOTES: POST-GELATIN EMBOLIZATION ANGIOGRAM; RECURRENT UAVM, NOTES: REPEATED SELECTIVE UTERINE ANGIOGRAM; ULTRASOUND UTERUS: ACUTE UROGENITAL BLEEDING DUE TO UAVM. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION. CAUSALITY FOR "ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM)" AND "PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). INFOMATION FROM LITERATURE ARTICLE: ABSTRACT: PURPOSE: TO EVALUATE THE EFFICACY AND COMPLICATIONS OF ABSORBABLE HAEMOSTATIC GELATIN UTERINE ARTERY EMBOLISATION FOR SYMPTOMATIC ACQUIRED UTERINE ARTERIO-VENOUS MALFORMATION (UAVM). METHODS: ALL THE ADULT FEMALE PATIENTS WHO HAD ACUTE UROGENITAL BLEEDING DUE TO UAVM CONFIRMED ON ULTRASOUND AND RECEIVED UTERINE ARTERY EMBOLISATION (UAE) FOR UAVM IN A TERTIARY INSTITUTION BETWEEN (B)(6) 2000 AND (B)(6) 2024 WERE INCLUDED. PATIENTS WHO HAD UAE FOR OTHER CAUSES WERE EXCLUDED. CAUSES OF UAVM, EMBOLIC AGENTS USED, PROCEDURAL SUCCESS, RECURRENT GENITAL BLEEDING, AND COMPLICATIONS LIKE PULMONARY EMBOLISM AND GROIN BLEEDING WERE RECORDED. RESULTS: SEVEN FEMALE PATIENTS (MEAN AGE: 34 YEARS) WITH 8 UAE PROCEDURES WERE INCLUDED, WITH THREE POSTPARTUM AND FOUR AFTER MISCARRIAGES. THE MEAN LENGTH OF FOLLOW-UP AFTER UAE WAS 50 MONTHS. ABSORBABLE GELATIN WAS USED IN SIX PATIENTS, AND POLYVINYL ALCOHOL (PVA) PARTICLES WERE USED IN ONE PATIENT. 5/6 PATIENTS (83.3%) HAD SUCCESSFUL UAE WITH ABSORBABLE HAEMOSTATIC GELATIN. THERE WERE NO PROCEDURE-RELATED COMPLICATIONS, INCLUDING PULMONARY EMBOLISM AND UTERINE INFARCTS. ONLY ONE PATIENT REQUIRED A REPEATED UAE 33 DAYS LATER FOR RECURRENT VAGINAL BLEEDING, WHICH REQUIRED SODIUM TETRADECYL SULPHATE INJECTION AND MICROCOILS DURING EMBOLISATION. CONCLUSION: ACQUIRED UAVM IS VERY RARE BUT LIFE-THREATENING. ABSORBABLE HAEMOSTATIC GELATIN, A TEMPORARY EMBOLIC AGENT, APPEARS SAFE AND EFFECTIVE IN TREATING UAVM WITH UTERINE PRESERVATION. IT ELIMINATES THE POTENTIAL RISK OF UTERINE INFARCTION THAT MIGHT OCCUR WITH PERMANENT EMBOLIC AGENTS. A 33-YEAR-OLD FEMALE WITH SIGNIFICANT BLEEDING POST DILATION AND CURETTAGE (D&C) FOR MISCARRIAGE. SELECTIVE LEFT UTERINE ANGIOGRAM DEMONSTRATED UAVM WITH EARLY VENOUS FILLING. POST-GELATIN EMBOLISATION ANGIOGRAM SHOWED MUCH REDUCED CONTRAST FILLING (B) OF THE VASCULAR ABNORMALITY. THIS PATIENT PRESENTED 33 DAYS LATER WITH RECURRENT VAGINAL BLEEDING. THE REPEATED SELECTIVE UTERINE ANGIOGRAM CONFIRMED RECURRENT UAVM. THIS WAS SUCCESSFULLY EMBOLIZED WITH MICRO-COILS AND SODIUM TETRADECYL SULPHATE. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6) 2025 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' 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.ADDITIONAL PRODUCT QUALITY INFORMATION: "INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' 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. " FOLLOW-UP (10NOV2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: DRUG EFFICACY MAY VARY FROM PERSON TO PERSON AND IS SUBJECT TO MULTIPLE FACTORS INCLUDING PHARMACOKINETICS, SEVERITY OF DISEASE AND PATIENT GENERAL HEALTH CONDITION. THE POSSIBILITY OF AN ASSOCIATION BETWEEN THE EVENT THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION IN THE CONTEXT OF OFF LABEL USE AND THE SUSPECT PRODUCT ABSORBABLE GELATIN CANNOT BE FULLY EXCLUDED. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1525335 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Other| R |