ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2024-00029
- Event Type
- Death
- Date Received
- August 9, 2024
- Report Date
- August 5, 2024
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6)2024 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED' 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 19NOV2024 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED' 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 19NOV2024 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED' 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.
INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION [OFF LABEL USE], INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION [DEVICE USE ISSUE], THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE [DRUG INEFFECTIVE FOR UNAPPROVED INDICATION], THE PATIENT DIED DUE TO RESPIRATORY FAILURE [RESPIRATORY FAILURE], NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER EMBOLIZATION FOR DUODENAL ULCER BLEEDING ORIGINATING FROM CYSTIC ARTERY EROSION", CVIR ENDOVASCULAR, 2024; VOL:7(1), DOI:10.1186/S42155-024-00470-6. A 90-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "ADMITTED" (UNSPECIFIED IF ONGOING); "TYPE II RESPIRATORY FAILURE" (UNSPECIFIED IF ONGOING); "CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (UNSPECIFIED IF ONGOING); "CORONARY STENT IMPLANTATION" (UNSPECIFIED IF ONGOING); "MELENA" (UNSPECIFIED IF ONGOING); "MASSIVE HEMATEMESIS" (UNSPECIFIED IF ONGOING); "HEMATOCHEZIA" (UNSPECIFIED IF ONGOING); "A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PAST DRUG HISTORY INCLUDED: ASPIRIN FOR ANTIPLATELET TREATMENT. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH), DEVICE USE ISSUE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION"; DRUG INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH), OUTCOME "FATAL", DESCRIBED AS "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE"; RESPIRATORY FAILURE (DEATH), OUTCOME "FATAL", DESCRIBED AS "THE PATIENT DIED DUE TO RESPIRATORY FAILURE". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ANGIOGRAM: WHICH DID NOT IDENTIFY ANY POSITIVE SIGNS; CONFIRMS SUCCESSFUL OCCLUSION OF THE BLEEDING BRAN, NOTES: BRANCHES OF THE CYSTIC ARTERY WITH GELATIN SPONGE PARTICLES AND COILS; DEMONSTRATES CONTRAST EXTRAVASATION; COMPUTERISED TOMOGRAM: REVEALED CONTRAST EXTRAVASATION IN CLOSE PROXIMITY, NOTES: PROXIMITY TO THE GALLBLADDER; ENDOSCOPY: IDENTIFIED A POST-BULBAR DUODENAL ULCER WITH ACTIV, NOTES: ACTIVE BLEEDING, WHICH WAS UNRESPONSIVE TO ENDOSCOPIC HEMOSTASIS. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, DEVICE USE ISSUE, DRUG INEFFECTIVE FOR UNAPPROVED INDICATION. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION", "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE", "THE PATIENT DIED DUE TO RESPIRATORY FAILURE". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: A 90-YEAR-OLD MALE PATIENT WAS ADMITTED WITH TYPE II RESPIRATORY FAILURE DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE. HE HAD A HISTORY OF CORONARY STENT IMPLANTATION AND WAS ON DAILY ANTIPLATELET TREATMENT WITH ASPIRIN, WITH NO HISTORY OF BILIARY SYSTEM DISEASE. TWO WEEKS AFTER ADMISSION, THE PATIENT DEVELOPED MELENA, WHICH PROGRESSED TO MASSIVE HEMATEMESIS AND HEMATOCHEZIA, REQUIRING TRANSFUSION AND VASOACTIVE THERAPY. EMERGENCY ENDOSCOPY IDENTIFIED A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING, WHICH WAS UNRESPONSIVE TO ENDOSCOPIC HEMOSTASIS. SUBSEQUENTLY, THE PATIENT UNDERWENT EMERGENCY ANGIOGRAPHY, WHICH DID NOT IDENTIFY ANY POSITIVE SIGNS, AND EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION WAS PERFORMED USING GELATIN SPONGE PARTICLES AND COILS. HOWEVER, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE. ADDITIONAL COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED CONTRAST EXTRAVASATION IN CLOSE PROXIMITY TO THE GALLBLADDER. SUPER-SELECTIVE CATHETERIZATION OF THE CYSTIC ARTERY WAS PERFORMED, REVEALING CONTRAST EXTRAVASATION. THE BLEEDING BRANCHES OF THE CYSTIC ARTERY WERE EMBOLIZED WITH GELATIN SPONGE PARTICLES AND COILS. AFTER THE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY STABLE FOR FOUR MONTHS WITHOUT ANY RECURRENT GASTROINTESTINAL BLEEDING. ULTIMATELY, THE PATIENT DIED DUE TO RESPIRATORY FAILURE. CAUSALITY FOR "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION", "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE" AND "THE PATIENT DIED DUE TO RESPIRATORY FAILURE" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION)., COMMENT: THE EVENTS RESPIRATORY FAILURE AND DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 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] INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION [OFF LABEL USE], INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION [DEVICE USE ISSUE], THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE [DRUG INEFFECTIVE FOR UNAPPROVED INDICATION], THE PATIENT DIED DUE TO RESPIRATORY FAILURE [RESPIRATORY FAILURE], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER EMBOLIZATION FOR DUODENAL ULCER BLEEDING ORIGINATING FROM CYSTIC ARTERY EROSION", CVIR ENDOVASCULAR, 2024; VOL:7(1), DOI:10.1186/S42155-024-00470-6. A (B)(6) MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "ADMITTED" (UNSPECIFIED IF ONGOING); "TYPE II RESPIRATORY FAILURE" (UNSPECIFIED IF ONGOING); "CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (UNSPECIFIED IF ONGOING); "CORONARY STENT IMPLANTATION" (UNSPECIFIED IF ONGOING); "MELENA" (UNSPECIFIED IF ONGOING); "MASSIVE HEMATEMESIS" (UNSPECIFIED IF ONGOING); "HEMATOCHEZIA" (UNSPECIFIED IF ONGOING); "A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PAST DRUG HISTORY INCLUDED: ASPIRIN FOR ANTIPLATELET TREATMENT. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH), DEVICE USE ISSUE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION"; DRUG INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH), OUTCOME "FATAL", DESCRIBED AS "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE"; RESPIRATORY FAILURE (DEATH), OUTCOME "FATAL", DESCRIBED AS "THE PATIENT DIED DUE TO RESPIRATORY FAILURE". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ANGIOGRAM: WHICH DID NOT IDENTIFY ANY POSITIVE SIGNS; CONFIRMS SUCCESSFUL OCCLUSION OF THE BLEEDING, NOTES: BRANCHES OF THE CYSTIC ARTERY WITH GELATIN SPONGE PARTICLES AND COILS; DEMONSTRATES CONTRAST EXTRAVASATION; COMPUTERISED TOMOGRAM: REVEALED CONTRAST EXTRAVASATION, NOTES: IN CLOSE PROXIMITY TO THE GALLBLADDER; ENDOSCOPY: POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING, NOTES: IDENTIFIED A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING, WHICH WAS UNRESPONSIVE TO ENDOSCOPIC HEMOSTASIS. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF DRUG INEFFECTIVE FOR UNAPPROVED INDICATION. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION", "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE", "THE PATIENT DIED DUE TO RESPIRATORY FAILURE". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: A (B)(6) MALE PATIENT WAS ADMITTED WITH TYPE II RESPIRATORY FAILURE DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE. HE HAD A HISTORY OF CORONARY STENT IMPLANTATION AND WAS ON DAILY ANTIPLATELET TREATMENT WITH ASPIRIN, WITH NO HISTORY OF BILIARY SYSTEM DISEASE. TWO WEEKS AFTER ADMISSION, THE PATIENT DEVELOPED MELENA, WHICH PROGRESSED TO MASSIVE HEMATEMESIS AND HEMATOCHEZIA, REQUIRING TRANSFUSION AND VASOACTIVE THERAPY. EMERGENCY ENDOSCOPY IDENTIFIED A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING, WHICH WAS UNRESPONSIVE TO ENDOSCOPIC HEMOSTASIS. SUBSEQUENTLY, THE PATIENT UNDERWENT EMERGENCY ANGIOGRAPHY, WHICH DID NOT IDENTIFY ANY POSITIVE SIGNS, AND EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION WAS PERFORMED USING GELATIN SPONGE PARTICLES AND COILS. HOWEVER, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE. ADDITIONAL COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED CONTRAST EXTRAVASATION IN CLOSE PROXIMITY TO THE GALLBLADDER. SUPER-SELECTIVE CATHETERIZATION OF THE CYSTIC ARTERY WAS PERFORMED, REVEALING CONTRAST EXTRAVASATION. THE BLEEDING BRANCHES OF THE CYSTIC ARTERY WERE EMBOLIZED WITH GELATIN SPONGE PARTICLES AND COILS. AFTER THE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY STABLE FOR FOUR MONTHS WITHOUT ANY RECURRENT GASTROINTESTINAL BLEEDING. ULTIMATELY, THE PATIENT DIED DUE TO RESPIRATORY FAILURE. CAUSALITY FOR "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION", "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE" AND "THE PATIENT DIED DUE TO RESPIRATORY FAILURE" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (05AUG2024): THIS IS A LITERATURE FOLLOW UP REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER EMBOLIZATION FOR DUODENAL ULCER BLEEDING ORIGINATING FROM CYSTIC ARTERY EROSION", CVIR ENDOVASCULAR, 2024; VOL:7(1), DOI:10.1186/S42155-024-00470-6. UPDATED INFORMATION: REPORTABILITY ASSESSMENT UPDATED. FOLLOW-UP (19NOV2024): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6)2024 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED' 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 (11FEB2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING ADDITIONAL FDA/IMDRF CODES (EVALUATION CODES)., COMMENT: THE EVENTS RESPIRATORY FAILURE AND DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 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]. INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION [OFF LABEL USE], INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION [DEVICE USE ISSUE], THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE [DRUG INEFFECTIVE FOR UNAPPROVED INDICATION], THE PATIENT DIED DUE TO RESPIRATORY FAILURE [RESPIRATORY FAILURE], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER EMBOLIZATION FOR DUODENAL ULCER BLEEDING ORIGINATING FROM CYSTIC ARTERY EROSION", CVIR ENDOVASCULAR, 2024; VOL:7(1), DOI:10.1186/S42155-024-00470-6. A 90-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "ADMITTED" (UNSPECIFIED IF ONGOING); "TYPE II RESPIRATORY FAILURE" (UNSPECIFIED IF ONGOING); "CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (UNSPECIFIED IF ONGOING); "CORONARY STENT IMPLANTATION" (UNSPECIFIED IF ONGOING); "MELENA" (UNSPECIFIED IF ONGOING); "MASSIVE HEMATEMESIS" (UNSPECIFIED IF ONGOING); "HEMATOCHEZIA" (UNSPECIFIED IF ONGOING); "A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PAST DRUG HISTORY INCLUDED: ASPIRIN FOR ANTIPLATELET TREATMENT. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH), DEVICE USE ISSUE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION"; DRUG INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH), OUTCOME "FATAL", DESCRIBED AS "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE"; RESPIRATORY FAILURE (DEATH), OUTCOME "FATAL", DESCRIBED AS "THE PATIENT DIED DUE TO RESPIRATORY FAILURE". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ANGIOGRAM: WHICH DID NOT IDENTIFY ANY POSITIVE SIGNS; CONFIRMS SUCCESSFUL OCCLUSION OF THE BLEEDING BRAN, NOTES: BRANCHES OF THE CYSTIC ARTERY WITH GELATIN SPONGE PARTICLES AND COILS; DEMONSTRATES CONTRAST EXTRAVASATION; COMPUTERISED TOMOGRAM: REVEALED CONTRAST EXTRAVASATION IN CLOSE PROXIMITY, NOTES: PROXIMITY TO THE GALLBLADDER; ENDOSCOPY: IDENTIFIED A POST-BULBAR DUODENAL ULCER WITH ACTIV, NOTES: ACTIVE BLEEDING, WHICH WAS UNRESPONSIVE TO ENDOSCOPIC HEMOSTASIS. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, DEVICE USE ISSUE, DRUG INEFFECTIVE FOR UNAPPROVED INDICATION. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION", "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE", "THE PATIENT DIED DUE TO RESPIRATORY FAILURE". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: A 90-YEAR-OLD MALE PATIENT WAS ADMITTED WITH TYPE II RESPIRATORY FAILURE DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE. HE HAD A HISTORY OF CORONARY STENT IMPLANTATION AND WAS ON DAILY ANTIPLATELET TREATMENT WITH ASPIRIN, WITH NO HISTORY OF BILIARY SYSTEM DISEASE. TWO WEEKS AFTER ADMISSION, THE PATIENT DEVELOPED MELENA, WHICH PROGRESSED TO MASSIVE HEMATEMESIS AND HEMATOCHEZIA, REQUIRING TRANSFUSION AND VASOACTIVE THERAPY. EMERGENCY ENDOSCOPY IDENTIFIED A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING, WHICH WAS UNRESPONSIVE TO ENDOSCOPIC HEMOSTASIS. SUBSEQUENTLY, THE PATIENT UNDERWENT EMERGENCY ANGIOGRAPHY, WHICH DID NOT IDENTIFY ANY POSITIVE SIGNS, AND EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION WAS PERFORMED USING GELATIN SPONGE PARTICLES AND COILS. HOWEVER, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE. ADDITIONAL COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED CONTRAST EXTRAVASATION IN CLOSE PROXIMITY TO THE GALLBLADDER. SUPER-SELECTIVE CATHETERIZATION OF THE CYSTIC ARTERY WAS PERFORMED, REVEALING CONTRAST EXTRAVASATION. THE BLEEDING BRANCHES OF THE CYSTIC ARTERY WERE EMBOLIZED WITH GELATIN SPONGE PARTICLES AND COILS. AFTER THE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY STABLE FOR FOUR MONTHS WITHOUT ANY RECURRENT GASTROINTESTINAL BLEEDING. ULTIMATELY, THE PATIENT DIED DUE TO RESPIRATORY FAILURE. CAUSALITY FOR "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION", "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE" AND "THE PATIENT DIED DUE TO RESPIRATORY FAILURE" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (05AUG2024):THIS IS A LITERATURE FOLLOW UP REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER EMBOLIZATION FOR DUODENAL ULCER BLEEDING ORIGINATING FROM CYSTIC ARTERY EROSION", CVIR ENDOVASCULAR, 2024; VOL:7(1), DOI:10.1186/S42155-024-00470-6. UPDATED INFORMATION: REPORTABILITY ASSESSMENT UPDATED. FOLLOW-UP (19NOV2024): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 19NOV2024 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED' 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., COMMENT: THE EVENTS RESPIRATORY FAILURE AND DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 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]. INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION [OFF LABEL USE], INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION [DEVICE USE ISSUE], THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE [DRUG INEFFECTIVE FOR UNAPPROVED INDICATION], THE PATIENT DIED DUE TO RESPIRATORY FAILURE [RESPIRATORY FAILURE], NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER EMBOLIZATION FOR DUODENAL ULCER BLEEDING ORIGINATING FROM CYSTIC ARTERY EROSION", CVIR ENDOVASCULAR, 2024; VOL:7(1), DOI:10.1186/S42155-024-00470-6. A (B)(6)-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "ADMITTED" (UNSPECIFIED IF ONGOING); "TYPE II RESPIRATORY FAILURE" (UNSPECIFIED IF ONGOING); "CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (UNSPECIFIED IF ONGOING); "CORONARY STENT IMPLANTATION" (UNSPECIFIED IF ONGOING); "MELENA" (UNSPECIFIED IF ONGOING); "MASSIVE HEMATEMESIS" (UNSPECIFIED IF ONGOING); "HEMATOCHEZIA" (UNSPECIFIED IF ONGOING); "A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING" (UNSPECIFIED IF ONGOING). THE PATIENT TOOK CONCOMITANT MEDICATIONS. PAST DRUG HISTORY INCLUDED: ASPIRIN FOR ANTIPLATELET TREATMENT. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH), DEVICE USE ISSUE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION"; DRUG INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH), OUTCOME "FATAL", DESCRIBED AS "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE"; RESPIRATORY FAILURE (DEATH), OUTCOME "FATAL", DESCRIBED AS "THE PATIENT DIED DUE TO RESPIRATORY FAILURE". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ANGIOGRAM: WHICH DID NOT IDENTIFY ANY POSITIVE SIGNS; CONFIRMS SUCCESSFUL OCCLUSION OF THE BLEEDING, NOTES: BRANCHES OF THE CYSTIC ARTERY WITH GELATIN SPONGE PARTICLES AND COILS; DEMONSTRATES CONTRAST EXTRAVASATION; COMPUTERISED TOMOGRAM: REVEALED CONTRAST EXTRAVASATION, NOTES: IN CLOSE PROXIMITY TO THE GALLBLADDER; ENDOSCOPY: POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING, NOTES: IDENTIFIED A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING, WHICH WAS UNRESPONSIVE TO ENDOSCOPIC HEMOSTASIS. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF DRUG INEFFECTIVE FOR UNAPPROVED INDICATION. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION", "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE", "THE PATIENT DIED DUE TO RESPIRATORY FAILURE". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: A (B)(6)-YEAR-OLD MALE PATIENT WAS ADMITTED WITH TYPE II RESPIRATORY FAILURE DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE. HE HAD A HISTORY OF CORONARY STENT IMPLANTATION AND WAS ON DAILY ANTIPLATELET TREATMENT WITH ASPIRIN, WITH NO HISTORY OF BILIARY SYSTEM DISEASE. TWO WEEKS AFTER ADMISSION, THE PATIENT DEVELOPED MELENA, WHICH PROGRESSED TO MASSIVE HEMATEMESIS AND HEMATOCHEZIA, REQUIRING TRANSFUSION AND VASOACTIVE THERAPY. EMERGENCY ENDOSCOPY IDENTIFIED A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING, WHICH WAS UNRESPONSIVE TO ENDOSCOPIC HEMOSTASIS. SUBSEQUENTLY, THE PATIENT UNDERWENT EMERGENCY ANGIOGRAPHY, WHICH DID NOT IDENTIFY ANY POSITIVE SIGNS, AND EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION WAS PERFORMED USING GELATIN SPONGE PARTICLES AND COILS. HOWEVER, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE. ADDITIONAL COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED CONTRAST EXTRAVASATION IN CLOSE PROXIMITY TO THE GALLBLADDER. SUPER-SELECTIVE CATHETERIZATION OF THE CYSTIC ARTERY WAS PERFORMED, REVEALING CONTRAST EXTRAVASATION. THE BLEEDING BRANCHES OF THE CYSTIC ARTERY WERE EMBOLIZED WITH GELATIN SPONGE PARTICLES AND COILS. AFTER THE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY STABLE FOR FOUR MONTHS WITHOUT ANY RECURRENT GASTROINTESTINAL BLEEDING. ULTIMATELY, THE PATIENT DIED DUE TO RESPIRATORY FAILURE. CAUSALITY FOR "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION", "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE" AND "THE PATIENT DIED DUE TO RESPIRATORY FAILURE" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (05AUG2024):THIS IS A LITERATURE FOLLOW UP REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER EMBOLIZATION FOR DUODENAL ULCER BLEEDING ORIGINATING FROM CYSTIC ARTERY EROSION", CVIR ENDOVASCULAR, 2024; VOL:7(1), DOI:10.1186/S42155-024-00470-6. UPDATED INFORMATION: REPORTABILITY ASSESSMENT UPDATED. FOLLOW-UP (19NOV2024): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 19NOV2024 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED' 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 (11FEB2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING ADDITIONAL FDA/IMDRF CODES (EVALUATION CODES). FOLLOW-UP (12FEB2025): THIS IS A LITERATURE FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING UPDATED REPORTABLE ASSESSMENT (CASE CONFIRMED AS REPORTABLE FOR THE US DUE TO SERIOUS INJURY THAT NECESSITATES MEDICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE, REPORTABLE FOR REST OF WORLD (ROW) DUE TO AN ANTICIPATED SERIOUS DETERIORATION IN HEALTH)., COMMENT: THE EVENTS RESPIRATORY FAILURE AND DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 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]. INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION [OFF LABEL USE], INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION [DEVICE USE ISSUE], THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE [DRUG INEFFECTIVE FOR UNAPPROVED INDICATION], THE PATIENT DIED DUE TO RESPIRATORY FAILURE [RESPIRATORY FAILURE], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER EMBOLIZATION FOR DUODENAL ULCER BLEEDING ORIGINATING FROM CYSTIC ARTERY EROSION", CVIR ENDOVASCULAR, 2024; VOL:7(1), DOI:10.1186/S42155-024-00470-6. A 90-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "ADMITTED" (UNSPECIFIED IF ONGOING); "TYPE II RESPIRATORY FAILURE" (UNSPECIFIED IF ONGOING); "CHRONIC OBSTRUCTIVE PULMONARY DISEASE" (UNSPECIFIED IF ONGOING); "CORONARY STENT IMPLANTATION" (UNSPECIFIED IF ONGOING); "MELENA" (UNSPECIFIED IF ONGOING); "MASSIVE HEMATEMESIS" (UNSPECIFIED IF ONGOING); "HEMATOCHEZIA" (UNSPECIFIED IF ONGOING); "A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PAST DRUG HISTORY INCLUDED: ASPIRIN FOR ANTIPLATELET TREATMENT. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH), DEVICE USE ISSUE (DEATH), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION"; DRUG INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH), OUTCOME "FATAL", DESCRIBED AS "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE"; RESPIRATORY FAILURE (DEATH), OUTCOME "FATAL", DESCRIBED AS "THE PATIENT DIED DUE TO RESPIRATORY FAILURE". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ANGIOGRAM: WHICH DID NOT IDENTIFY ANY POSITIVE SIGNS; CONFIRMS SUCCESSFUL OCCLUSION OF THE BLEEDING BRAN, NOTES: BRANCHES OF THE CYSTIC ARTERY WITH GELATIN SPONGE PARTICLES AND COILS; DEMONSTRATES CONTRAST EXTRAVASATION; COMPUTERISED TOMOGRAM: REVEALED CONTRAST EXTRAVASATION IN CLOSE PROXIMITY, NOTES: PROXIMITY TO THE GALLBLADDER; ENDOSCOPY: IDENTIFIED A POST-BULBAR DUODENAL ULCER WITH ACTIV, NOTES: ACTIVE BLEEDING, WHICH WAS UNRESPONSIVE TO ENDOSCOPIC HEMOSTASIS. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, DEVICE USE ISSUE, DRUG INEFFECTIVE FOR UNAPPROVED INDICATION. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION", "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE", "THE PATIENT DIED DUE TO RESPIRATORY FAILURE". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: A 90-YEAR-OLD MALE PATIENT WAS ADMITTED WITH TYPE II RESPIRATORY FAILURE DUE TO CHRONIC OBSTRUCTIVE PULMONARY DISEASE. HE HAD A HISTORY OF CORONARY STENT IMPLANTATION AND WAS ON DAILY ANTIPLATELET TREATMENT WITH ASPIRIN, WITH NO HISTORY OF BILIARY SYSTEM DISEASE. TWO WEEKS AFTER ADMISSION, THE PATIENT DEVELOPED MELENA, WHICH PROGRESSED TO MASSIVE HEMATEMESIS AND HEMATOCHEZIA, REQUIRING TRANSFUSION AND VASOACTIVE THERAPY. EMERGENCY ENDOSCOPY IDENTIFIED A POST-BULBAR DUODENAL ULCER WITH ACTIVE BLEEDING, WHICH WAS UNRESPONSIVE TO ENDOSCOPIC HEMOSTASIS. SUBSEQUENTLY, THE PATIENT UNDERWENT EMERGENCY ANGIOGRAPHY, WHICH DID NOT IDENTIFY ANY POSITIVE SIGNS, AND EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION WAS PERFORMED USING GELATIN SPONGE PARTICLES AND COILS. HOWEVER, THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE. ADDITIONAL COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED CONTRAST EXTRAVASATION IN CLOSE PROXIMITY TO THE GALLBLADDER. SUPER-SELECTIVE CATHETERIZATION OF THE CYSTIC ARTERY WAS PERFORMED, REVEALING CONTRAST EXTRAVASATION. THE BLEEDING BRANCHES OF THE CYSTIC ARTERY WERE EMBOLIZED WITH GELATIN SPONGE PARTICLES AND COILS. AFTER THE EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY STABLE FOR FOUR MONTHS WITHOUT ANY RECURRENT GASTROINTESTINAL BLEEDING. ULTIMATELY, THE PATIENT DIED DUE TO RESPIRATORY FAILURE. CAUSALITY FOR "INDICATION: EMPIRICAL GASTRODUODENAL ARTERY EMBOLIZATION", "THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AFTER THE PROCEDURE" AND "THE PATIENT DIED DUE TO RESPIRATORY FAILURE" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (05AUG2024):THIS IS A LITERATURE FOLLOW UP REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER EMBOLIZATION FOR DUODENAL ULCER BLEEDING ORIGINATING FROM CYSTIC ARTERY EROSION", CVIR ENDOVASCULAR, 2024; VOL:7(1), DOI:10.1186/S42155-024-00470-6. UPDATED INFORMATION: REPORTABILITY ASSESSMENT UPDATED., COMMENT: THE EVENTS RESPIRATORY FAILURE AND DRUG INEFFECTIVE FOR UNAPPROVED INDICATION 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2493240 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Male | Death |