ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2022-00006
- Event Type
- Death
- Date Received
- July 26, 2022
- Report Date
- July 19, 2022
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS 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 COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS 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. SITE INVESTIGATION: REVIEW OF COMPLAINTS FOR GELFOAM SPONGE AND POWDER 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. THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS 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] ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS WAS PERFORMED/RECURRENCE OF HAEMORRHAGE COULD NOT BE PREVENTED [OFF LABEL USE], ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS WAS PERFORMED/RECURRENCE OF HAEMORRHAGE COULD NOT BE PREVENTED [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], PNEUMOTHORAX [PNEUMOTHORAX], PROGRESSION OF RESPIRATORY FAILURE [RESPIRATORY FAILURE], AGGRAVATION OF VENTILATION-PERFUSION IMBALANCE DUE TO EMBOLIZATION [VENTILATION PERFUSION MISMATCH], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF KCNT1 GENE-RELATED EPILEPSY PRESENTING WITH A FATAL OUTCOME DESPITE ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS FOR HAEMORRHAGE FROM AORTOPULMONARY COLLATERAL ARTERY", THE 6TH ANNUAL KANTO KOSHINETSU REGIONAL MEETING OF THE JAPANESE SOCIETY OF INTE, 2022; PGS:104. A 4-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR HAEMORRHAGE. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "KCNT1 GENE-RELATED EPILEPSY" (UNSPECIFIED IF ONGOING); "PULMONARY HAEMORRHAGE" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE(DEATH/MEDICALLY SIGNIFICANT), THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH/MEDICALLY SIGNIFICANT), OUTCOME "FATAL", BOTH DESCRIBED AS "ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS WAS PERFORMED/RECURRENCE OF HAEMORRHAGE COULD NOT BE PREVENTED"; PNEUMOTHORAX (DEATH/MEDICALLY SIGNIFICANT), OUTCOME "FATAL"; RESPIRATORY FAILURE (DEATH/MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "PROGRESSION OF RESPIRATORY FAILURE"; VENTILATION PERFUSION MISMATCH (DEATH/MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "AGGRAVATION OF VENTILATION-PERFUSION IMBALANCE DUE TO EMBOLIZATION". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: PROLIFERATION OF AORTOPULMONARY COLLATERAL, NOTES: ARTERIES SPREADING OVER BOTH LUNG FIELDS; UNKNOWN RESULTS; ENDOSCOPY UPPER GASTROINTESTINAL TRACT: UNKNOWN RESULTS; LARYNGOSCOPY: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION, PNEUMOTHORAX, RESPIRATORY FAILURE, VENTILATION PERFUSION MISMATCH. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "PNEUMOTHORAX", "PROGRESSION OF RESPIRATORY FAILURE". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL DETAILS AS FOLLOWS: THE CASE CONCERNS WITH A 4-YEAR-OLD GIRL WHO PRESENTED WITH SEIZURES FROM THE NEONATAL PERIOD. THE PATIENT WAS DIAGNOSED WITH KCNT1 GENE-RELATED EPILEPSY AND WAS TREATED ACCORDINGLY. THE PATIENT WAS URGENTLY TRANSPORTED TO A HOSPITAL FOR SUDDEN ONSET OF HAEMATEMESIS AND SHOCK AS A CHIEF COMPLAINT AND STARTED RECEIVING INTENSIVE CARE INCLUDING VENTILATOR MANAGEMENT. ENDOSCOPY UPPER GASTROINTESTINAL TRACT, LARYNGOSCOPY AND PLAIN COMPUTED TOMOGRAPHY (CT) OF THE WHOLE BODY WERE PERFORMED, BUT A SOURCE OF HAEMORRHAGE COULD NOT BE IDENTIFIED. THEREFORE, THE PATIENT WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT OF OUR HOSPITAL FOR DETAILED EXAMINATIONS AND TREATMENTS. WHILE VENTILATOR MANAGEMENT WAS CONTINUED UNDER DEEP SEDATION, A LARGE AMOUNT OF HAEMORRHAGE WAS DETECTED IN THE INTUBATION TUBE 2 DAYS AFTER ADMISSION TO THE UNIT. CONTRAST-ENHANCED CT REVEALED PROLIFERATION OF AORTOPULMONARY COLLATERAL ARTERIES SPREADING OVER BOTH LUNG FIELDS. IT WAS DIAGNOSED AS PULMONARY HAEMORRHAGE DUE TO ABNORMAL DISRUPTION OF BLOOD VESSELS, AND EMERGENCY EMBOLIZATION WAS PERFORMED ON THE SAME DAY. VENTILATOR MANAGEMENT WAS CONTINUED FOR PULMONARY HAEMORRHAGE AND POST-EMBOLIZATION ATELECTASIS, AND PROPHYLACTIC EMBOLIZATION WAS ADDITIONALLY PERFORMED ON HOSPITAL DAY 9. SUBSEQUENTLY, VENTILATOR ASSOCIATED PNEUMONIA WAS COMPLICATED. IT WAS CONTINUED TO BE DIFFICULT TO WEAN FROM VENTILATOR MANAGEMENT. SINCE PULMONARY HAEMORRHAGE RECURRED ON HOSPITAL DAY 16, EMERGENCY EMBOLIZATION WAS PERFORMED AGAIN. DESPITE ADDITIONAL THERAPIES (INCLUDING HIGH-FREQUENCY OSCILLATORY VENTILATION AND PRONE THERAPY/MANAGEMENT), THE PATIENT DIED ON HOSPITAL DAY 17 DUE TO PROGRESSION OF RESPIRATORY FAILURE AND ONSET OF PNEUMOTHORAX. FOLLOW-UP ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED FATAL EVENTS PNEUMOTHORAX; PROGRESSION OF RESPIRATORY FAILURE AND AGGRAVATION OF VENTILATION-PERFUSION IMBALANCE DUE TO EMBOLIZATION WERE ASSOCIATED WITH OFF LABEL USE OF ABSORBABLE GELATIN (ABSORBABLE GELATIN) FOR HAEMORRHAGE FROM AORTOPULMONARY COLLATERAL ARTERY AND THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION. THIS CASE WILL BE REASSESSED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. 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] ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS WAS PERFORMED/RECURRENCE OF HAEMORRHAGE COULD NOT BE PREVENTED [OFF LABEL USE], ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS WAS PERFORMED/RECURRENCE OF HAEMORRHAGE COULD NOT BE PREVENTED [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], PNEUMOTHORAX [PNEUMOTHORAX], PROGRESSION OF RESPIRATORY FAILURE [RESPIRATORY FAILURE], AGGRAVATION OF VENTILATION-PERFUSION IMBALANCE DUE TO EMBOLIZATION [VENTILATION PERFUSION MISMATCH], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF KCNT1 GENE-RELATED EPILEPSY PRESENTING WITH A FATAL OUTCOME DESPITE ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS FOR HAEMORRHAGE FROM AORTOPULMONARY COLLATERAL ARTERY", THE 6TH ANNUAL KANTO KOSHINETSU REGIONAL MEETING OF THE JAPANESE SOCIETY OF INTE, 2022; PGS:104. A 4-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR HAEMORRHAGE. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "KCNT1 GENE-RELATED EPILEPSY" (UNSPECIFIED IF ONGOING); "PULMONARY HAEMORRHAGE" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, MEDICALLY SIGNIFICANT), THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS WAS PERFORMED/RECURRENCE OF HAEMORRHAGE COULD NOT BE PREVENTED"; PNEUMOTHORAX (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL"; RESPIRATORY FAILURE (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "PROGRESSION OF RESPIRATORY FAILURE"; VENTILATION PERFUSION MISMATCH (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "AGGRAVATION OF VENTILATION-PERFUSION IMBALANCE DUE TO EMBOLIZATION". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: PROLIFERATION OF AORTOPULMONARY COLLATERAL, NOTES: ARTERIES SPREADING OVER BOTH LUNG FIELDS; UNKNOWN RESULTS; ENDOSCOPY UPPER GASTROINTESTINAL TRACT: UNKNOWN RESULTS; LARYNGOSCOPY: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION, PNEUMOTHORAX, RESPIRATORY FAILURE, VENTILATION PERFUSION MISMATCH. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "PNEUMOTHORAX", "PROGRESSION OF RESPIRATORY FAILURE". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL DETAILS AS FOLLOWS: THE CASE CONCERNS WITH A 4-YEAR-OLD GIRL WHO PRESENTED WITH SEIZURES FROM THE NEONATAL PERIOD. THE PATIENT WAS DIAGNOSED WITH KCNT1 GENE-RELATED EPILEPSY AND WAS TREATED ACCORDINGLY. THE PATIENT WAS URGENTLY TRANSPORTED TO A HOSPITAL FOR SUDDEN ONSET OF HAEMATEMESIS AND SHOCK AS A CHIEF COMPLAINT AND STARTED RECEIVING INTENSIVE CARE INCLUDING VENTILATOR MANAGEMENT. ENDOSCOPY UPPER GASTROINTESTINAL TRACT, LARYNGOSCOPY AND PLAIN COMPUTED TOMOGRAPHY (CT) OF THE WHOLE BODY WERE PERFORMED, BUT A SOURCE OF HAEMORRHAGE COULD NOT BE IDENTIFIED. THEREFORE, THE PATIENT WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT OF OUR HOSPITAL FOR DETAILED EXAMINATIONS AND TREATMENTS. WHILE VENTILATOR MANAGEMENT WAS CONTINUED UNDER DEEP SEDATION, A LARGE AMOUNT OF HAEMORRHAGE WAS DETECTED IN THE INTUBATION TUBE 2 DAYS AFTER ADMISSION TO THE UNIT. CONTRAST-ENHANCED CT REVEALED PROLIFERATION OF AORTOPULMONARY COLLATERAL ARTERIES SPREADING OVER BOTH LUNG FIELDS. IT WAS DIAGNOSED AS PULMONARY HAEMORRHAGE DUE TO ABNORMAL DISRUPTION OF BLOOD VESSELS, AND EMERGENCY EMBOLIZATION WAS PERFORMED ON THE SAME DAY. VENTILATOR MANAGEMENT WAS CONTINUED FOR PULMONARY HAEMORRHAGE AND POST-EMBOLIZATION ATELECTASIS, AND PROPHYLACTIC EMBOLIZATION WAS ADDITIONALLY PERFORMED ON HOSPITAL DAY 9. SUBSEQUENTLY, VENTILATOR ASSOCIATED PNEUMONIA WAS COMPLICATED. IT WAS CONTINUED TO BE DIFFICULT TO WEAN FROM VENTILATOR MANAGEMENT. SINCE PULMONARY HAEMORRHAGE RECURRED ON HOSPITAL DAY 16, EMERGENCY EMBOLIZATION WAS PERFORMED AGAIN. DESPITE ADDITIONAL THERAPIES (INCLUDING HIGH-FREQUENCY OSCILLATORY VENTILATION AND PRONE THERAPY/MANAGEMENT), THE PATIENT DIED ON HOSPITAL DAY 17 DUE TO PROGRESSION OF RESPIRATORY FAILURE AND ONSET OF PNEUMOTHORAX. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 23AUG2022 FOR ABSORBABLE GELATIN: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS 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 ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23AUG2022): THIS IS A FOLLOW-UP REPORT FROM THE PRODUCT QUALITY COMPLAINT AS FOLLOWING. NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATION RESULTS ADDITIONAL INFORMATION: INVESTIGATION RESULTS., COMMENT: THE REPORTED FATAL EVENTS PNEUMOTHORAX; PROGRESSION OF RESPIRATORY FAILURE AND AGGRAVATION OF VENTILATION-PERFUSION IMBALANCE DUE TO EMBOLIZATION WERE ASSOCIATED WITH OFF LABEL USE OF ABSORBABLE GELATIN (ABSORBABLE GELATIN) FOR HAEMORRHAGE FROM AORTOPULMONARY COLLATERAL ARTERY AND THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION. THIS CASE WILL BE REASSESSED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. 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] ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS WAS PERFORMED/RECURRENCE OF HAEMORRHAGE COULD NOT BE PREVENTED [OFF LABEL USE], ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS WAS PERFORMED/RECURRENCE OF HAEMORRHAGE COULD NOT BE PREVENTED [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], PNEUMOTHORAX [PNEUMOTHORAX], PROGRESSION OF RESPIRATORY FAILURE [RESPIRATORY FAILURE], AGGRAVATION OF VENTILATION-PERFUSION IMBALANCE DUE TO EMBOLIZATION [VENTILATION PERFUSION MISMATCH], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE: "A CASE OF KCNT1 GENE-RELATED EPILEPSY PRESENTING WITH A FATAL OUTCOME DESPITE ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS FOR HAEMORRHAGE FROM AORTOPULMONARY COLLATERAL ARTERY", THE 6TH ANNUAL KANTO KOSHINETSU REGIONAL MEETING OF THE JAPANESE SOCIETY OF INTE, 2022; PGS:104. A 4-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR HAEMORRHAGE. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "KCNT1 GENE-RELATED EPILEPSY" (UNSPECIFIED IF ONGOING); "PULMONARY HAEMORRHAGE" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, MEDICALLY SIGNIFICANT), THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "ENDOVASCULAR TREATMENT WITH MULTIPLE EMBOLIZATION MATERIALS WAS PERFORMED/RECURRENCE OF HAEMORRHAGE COULD NOT BE PREVENTED"; PNEUMOTHORAX (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL"; RESPIRATORY FAILURE (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "PROGRESSION OF RESPIRATORY FAILURE"; VENTILATION PERFUSION MISMATCH (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "AGGRAVATION OF VENTILATION-PERFUSION IMBALANCE DUE TO EMBOLIZATION". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: PROLIFERATION OF AORTOPULMONARY COLLATERAL, NOTES: ARTERIES SPREADING OVER BOTH LUNG FIELDS; UNKNOWN RESULTS; ENDOSCOPY UPPER GASTROINTESTINAL TRACT: UNKNOWN RESULTS; LARYNGOSCOPY: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION, PNEUMOTHORAX, RESPIRATORY FAILURE, VENTILATION PERFUSION MISMATCH. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "PNEUMOTHORAX", "PROGRESSION OF RESPIRATORY FAILURE". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL DETAILS AS FOLLOWS: THE CASE CONCERNS WITH A 4-YEAR-OLD GIRL WHO PRESENTED WITH SEIZURES FROM THE NEONATAL PERIOD. THE PATIENT WAS DIAGNOSED WITH KCNT1 GENE-RELATED EPILEPSY AND WAS TREATED ACCORDINGLY. THE PATIENT WAS URGENTLY TRANSPORTED TO A HOSPITAL FOR SUDDEN ONSET OF HAEMATEMESIS AND SHOCK AS A CHIEF COMPLAINT AND STARTED RECEIVING INTENSIVE CARE INCLUDING VENTILATOR MANAGEMENT. ENDOSCOPY UPPER GASTROINTESTINAL TRACT, LARYNGOSCOPY AND PLAIN COMPUTED TOMOGRAPHY (CT) OF THE WHOLE BODY WERE PERFORMED, BUT A SOURCE OF HAEMORRHAGE COULD NOT BE IDENTIFIED. THEREFORE, THE PATIENT WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT OF OUR HOSPITAL FOR DETAILED EXAMINATIONS AND TREATMENTS. WHILE VENTILATOR MANAGEMENT WAS CONTINUED UNDER DEEP SEDATION, A LARGE AMOUNT OF HAEMORRHAGE WAS DETECTED IN THE INTUBATION TUBE 2 DAYS AFTER ADMISSION TO THE UNIT. CONTRAST-ENHANCED CT REVEALED PROLIFERATION OF AORTOPULMONARY COLLATERAL ARTERIES SPREADING OVER BOTH LUNG FIELDS. IT WAS DIAGNOSED AS PULMONARY HAEMORRHAGE DUE TO ABNORMAL DISRUPTION OF BLOOD VESSELS, AND EMERGENCY EMBOLIZATION WAS PERFORMED ON THE SAME DAY. VENTILATOR MANAGEMENT WAS CONTINUED FOR PULMONARY HAEMORRHAGE AND POST-EMBOLIZATION ATELECTASIS, AND PROPHYLACTIC EMBOLIZATION WAS ADDITIONALLY PERFORMED ON HOSPITAL DAY 9. SUBSEQUENTLY, VENTILATOR ASSOCIATED PNEUMONIA WAS COMPLICATED. IT WAS CONTINUED TO BE DIFFICULT TO WEAN FROM VENTILATOR MANAGEMENT. SINCE PULMONARY HAEMORRHAGE RECURRED ON HOSPITAL DAY 16, EMERGENCY EMBOLIZATION WAS PERFORMED AGAIN. DESPITE ADDITIONAL THERAPIES (INCLUDING HIGH-FREQUENCY OSCILLATORY VENTILATION AND PRONE THERAPY/MANAGEMENT), THE PATIENT DIED ON HOSPITAL DAY 17 DUE TO PROGRESSION OF RESPIRATORY FAILURE AND ONSET OF PNEUMOTHORAX. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 23AUG2022 FOR ABSORBABLE GELATIN: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS 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 25AUG2022 FOR ABSORBABLE GELATIN: SITE INVESTIGATION: REVIEW OF COMPLAINTS FOR GELFOAM SPONGE AND POWDER 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. THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS 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 ATTEMPTS ARE COMPLETED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (23AUG2022): THIS IS A FOLLOW-UP REPORT FROM PFIZER PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. FOLLOW-UP (25AUG2022): THIS IS A FOLLOW-UP REPORT FROM PFIZER PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: THE REPORTED FATAL EVENTS PNEUMOTHORAX; PROGRESSION OF RESPIRATORY FAILURE AND AGGRAVATION OF VENTILATION-PERFUSION IMBALANCE DUE TO EMBOLIZATION WERE ASSOCIATED WITH OFF LABEL USE OF ABSORBABLE GELATIN (ABSORBABLE GELATIN) FOR HAEMORRHAGE FROM AORTOPULMONARY COLLATERAL ARTERY AND THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION. THIS CASE WILL BE REASSESSED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. 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 |
|---|---|---|---|---|---|---|---|
| 1340842 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Female | Other| D |