GELFOAM
Report
- Report Number
- 1810189-2023-00011
- Event Type
- Injury
- Date Received
- April 20, 2023
- Report Date
- April 12, 2023
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE WORST-CASE SEVERITY WAS S5. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REQUIRING ESCALATION. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. THE COMPLAINT AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND IT WAS DETERMINED THAT OUR CONTAINMENT ACTION IS A NOTIFICATION TO MANAGEMENT. A FULL INVESTIGATION WILL BE PERFORMED. THIS IS A COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM. THE INVESTIGATION WILL INCLUDE A REVIEW OF COMPLAINTS WITH KNOWN BATCH NUMBERS DETERMINED TO BE WITHIN SCOPE. INVESTIGATION FINDINGS: SUMMARY OF INVESTIGATION: A PERFORMANCE NOT AS INDICATED IN LABEL COMPLAINT WAS RECEIVED FOR AN UNKNOWN LOT OF GELFOAM. 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. REGULATORY/ MARKET ASSESSMENT: ROOT CAUSE ANALYSIS/IDENTIF: PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER KALAMAZOO SITE. IMPACT ANALYSIS: THE WORST-CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S5. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE FINAL DETERMINED SCOPE AND THE INABILITY TO DETERMINE A ROOT CAUSE FOR THE REPORTED COMPLAINT, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE IS NO IMPACT TO THE QUALITY OF THE LOT. IMPROVE/CONTROL: CORRECTIVE /PREVENTIVE ACTION: INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE KALAMAZOO MDCP TEAM FOR REVIEW. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE 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.' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. 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. SCOPE OF COMPL. INVESTIGATION: THE INITIAL SCOPE OF THIS INVESTIGATION IS LIMITED TO A REVIEW OF COMPLAINTS WITH KNOWN BATCH NUMBERS RECEIVED WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL FOR THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED BECAUSE ANY PRODUCT ON THE MARKET WITHIN EXPIRY WOULD BE CAPTURED WITHIN THAT TIMEFRAME. A QUERY OF THE COMPLAINTS DATABASE FOR THE REPORTED PRODUCT, CLASS, AND SUB-LASS CAPTURED THE REQUIRED 5 DATA POINTS FOR THE REPORTED PRODUCT, CLASS, AND SUB-CLASS. OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. THE FINAL SCOPE WAS NOT EXPANDED AS A RESULT OF INVESTIGATION. DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED THROUGH A FILTER WITH NITROGEN TO EXTRUDE THE LARGE, SOLID SPONGE BRICKS. THE BRICKS ARE DRIED, TRIMMED AND SPLIT. THE SPLIT BRICKS ARE THEN MILLED TO FORM POWDER. THE POWDER IS COLLECTED IN HIGH DENSITY POLYETHYLENE BAGS AND THEN SEALED INTO BULK CONTAINERS. THE GELFOAM POWDER IS THEN FILLED INTO INNER ENVELOPES USING A POWDER FILLING DEVICE. EACH ENVELOPE IS FILLED WITH A TARGET OF 1.2 GRAMS PER ENVELOPE AND A MINIMUM OF 1.0 GRAM PER ENVELOPE. TWO WEIGHT CHECKS OF EACH POWDER FILLING DEVICE ARE CONDUCTED AT 30-MINUTE INTERVALS TO ASSURE THAT THE DEVICE IS DISPENSING THE PROPER AMOUNT OF POWDER. THE FINAL PRODUCT YIELD IS CALCULATED AGAINST LIMITS FOR THE PRODUCT. THE INNER ENVELOPES ARE FOLDED OVER TWICE AND INSERTED INTO SLEEVES. THE FILLED SLEEVES ARE PLACED INTO TRAYS. THE SLEEVES (PEEL POUCHES) ARE SEALED, AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE ENVELOPES HAVE THE PROPER APPEARANCE, SEAL AND PRINT, AND ALL NOTED DEFECTIVE PRODUCT IS REMOVED FROM THE LOT PRIOR TO FINAL PACKAGING AND NO OPEN SIDE SEALS WERE OBSERVED. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. FOR GELFOAM SPONGE, THE BILL OF MATERIALS LISTS THE SPECIFIC PRODUCT COMPONENTS AND WEIGHTS REQUIRED FOR THE FORMULATION OF EACH BATCH. ALL MANUFACTURING MIXING SPEEDS, TIMES, AND TEMPERATURES HAVE SPECIFICATION CRITERIA. ALL EXTRUSION PARAMETERS HAVE REQUIRED SPECIFICATIONS. AFTER THE PRODUCT IS EXTRUDED INTO BRICKS, THE BRICKS ARE INSPECTED PRIOR TO BEING SLICED INTO INDIVIDUAL SPONGES. AFTER THE BRICKS ARE SLICED INTO SPONGES, A VISUAL INSPECTION IS PERFORMED FOR CONSISTENCY, UNIFORMITY, SHAPE, AND SIZE AT THE BEGINNING, MIDDLE, AND END OF SHIFTS AND EVERY FOUR HOURS IN BETWEEN. ALL DEFECTIVE SPONGES ARE IDENTIFIED AND REMOVED. THE GELFOAM IS PLACED INTO INNER ENVELOPES AND TRANSFERRED TO THE DOYEN PACKAGING EQUIPMENT TO PACKAGE THE ENVELOPES INTO PEEL POUCHES. THE DOYEN TAKES SIX ENVELOPES PER ROTATION BY SUCTION AND LOADS THEM ONTO A CONVEYER BELT AGAINST AN ALIGNMENT TAB. TWO OPERATORS SIT AT THE DOYEN TO CORRECT ALIGNMENT ISSUES PRIOR TO SEALING. THE FRONT AND BACK PAPERS, WHICH MAKE UP THE OUTER PEEL POUCH, ENCLOSE EACH INDIVIDUAL INNER ENVELOPE ENTIRELY WITH A FOUR-SIDED, HEAT-ACTIVATED ADHESIVE SEAL. THE TOP, BOTTOM, AND SIDES OF THE OUTER PEEL POUCHES ARE SEALED BY THREE DIFFERENT PARTS OF THE DOYEN WHICH EACH HAVE SEPARATE TEMPERATURE CONTROLS. EACH TEMPERATURE CONTROL IS VERIFIED AND DOCUMENTED IN THE BATCH RECORD. THE PEEL POUCHES ARE SEALED, AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE PEEL POUCHES HAVE THE PROPER APPEARANCE, SEAL AND PRINT. A SEAL INTEGRITY TEST (SIT) IS UTILIZED THROUGHOUT THE FINAL PACKAGING TO ENSURE THE SIDE SEALS OF THE PEEL POUCHES ARE ACCEPTABLE. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. AUDITS ARE PERFORMED ON THE FINISHED PACKAGED UNITS AT REGULAR INTERVALS THROUGHOUT THE FINAL PACKAGING PROCESS.
EVENT VERBATIM [PREFERRED TERM] THE TARGET ARTERY WAS SUCCESSFULLY OCCLUDED WITH GELFOAM; HOWEVER, THE PATIENT RE-BLED FROM THE SAME VESSEL [OFF LABEL USE], THE TARGET ARTERY WAS SUCCESSFULLY OCCLUDED WITH GELFOAM; HOWEVER, THE PATIENT RE-BLED FROM THE SAME VESSEL [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE: "SHORT-INTERVAL RECANALIZATION AFTER GELFOAM OCCLUSION", RADIOLOGY CASE REPORTS, 2022; VOL:17, PGS:3835-3837, DOI:10.1016/J.RADCR.2022.07.002. BACKGROUND: GELFOAM (PFIZER, NEW YORK, NY) IS A TEMPORARY VASCULAR EMBOLIZATION AGENT, BUT THE DURATION OF SUBSEQUENT VESSEL OCCLUSION IS UNCLEAR AS FEW PATIENTS HAVE REPEAT ANGIOGRAPHY FOLLOWING GELFOAM EMBOLIZATION. BEGINNING IN THE 1970S, CONTROL OF TRAUMATIC ARTERIAL HEMORRHAGE UTILIZING GELFOAM HAS BEEN REPORTED. WE REPORT A CASE OF RECANALIZATION OF AN OCCLUDED RIGHT HEPATIC ARTERY LESS THAN 48 HOURS AFTER TRANSCATHETER EMBOLIZATION WITH GELFOAM SLURRY. METHODS: THE PATIENT, A 66-YEAR-OLD MALE, HAD A PAST MEDICAL HISTORY INCLUDING CIRRHOSIS SECONDARY TO ALCOHOL USE AND CHRONIC HEPATITIS B. HE INITIALLY PRESENTED TO AN OUTSIDE HOSPITAL WITH A 1-2 DAY HISTORY OF FATIGUE, MALAISE, AND GENERALIZED WEAKNESS. HE COMPLAINED OF RIGHT-UPPER-QUADRANT ABDOMINAL PAIN AND INCREASING ABDOMINAL DISTENTION. A PERITONEAL ASPIRATE WAS OBTAINED WHICH WAS FRANKLY BLOODY AND THE PATIENT WAS STARTED EMPIRICALLY ON ANTIBIOTICS FOR SPONTANEOUS BACTERIAL PERITONITIS (SBP). HE BECAME HYPOTENSIVE (SYSTOLIC BLOOD PRESSURES IN THE 60-70 MMHG RANGE) AND WAS VOLUME RESUSCITATED WITH INTRAVENOUS FLUIDS. A CT OF THE ABDOMEN AND PELVIS WAS PERFORMED, WHICH DEMONSTRATED MULTIPLE LIVER MASSES AND LARGEVOLUME HEMOPERITONEUM CONSISTENT WITH SPONTANEOUS RUPTURE OF RIGHT HEPATIC LOBE HEPATOCELLULAR CARCINOMA. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT UNDER THE TRAUMA SURGICAL SERVICE AT OUR INSTITUTION, AND INTERVENTIONAL RADIOLOGY (IR) WAS CONSULTED FOR HEPATIC ANGIOGRAPHY AND POSSIBLE EMBOLIZATION. AT THE TIME OF TRANSFER, HEMOGLOBIN WAS 9.3 GM/DL (BASELINE OF 12.6), HEMATOCRIT 28.8%, PLATELETS 138 X 10(3)/MCL, PROTHROMBIN TIME (PT) 19.4 SEC, INTERNATIONAL NORMALIZED RATIO (INR) 1.7, AND PARTIAL THROMBOPLASTIN TIME (PTT) 40 SEC. AFTER OBTAINING RIGHT COMMON FEMORAL ARTERY ACCESS, THE CELIAC AXIS WAS SELECTED WITH A 5-FR SOS CATHETER (ANGIODYNAMICS, QUEENSBURY, NY). A 3-FR HIGH FLOW RENEGADE CATHETER (BOSTON SCIENTIFIC, MARLBOROUGH, MA) AND A 0.018 GUIDE WIRE WERE USED TO SELECT THE PROPER HEPATIC ARTERY. ANGIOGRAPHY SHOWED TUMOR VASCULARITY IN THE RIGHT LOBE OF THE LIVER WITH 2 FOCI OF ACTIVE EXTRAVASATION. THE 3-FR CATHETER AND 0.018 WIRE WERE USED TO SUBSELECT THE RIGHT HEPATIC ARTERY (FIG. 1). THROUGH THE 3-FR MICROCATHETER, GELFOAM SLURRY (ONE GELFOAM SHEET CUT, SUSPENDED IN 20 ML OF 50% OMNIPAQUE 350 AND 50% NORMAL SALINE, IRRIGATED THROUGH A 3-WAY STOP-COCK 50 TIMES) WAS INJECTED TO 5-BEAT STASIS (FIG. 2). THE ANGIOGRAPHY WAS COMPLETED BY THE AFTERNOON OF DAY OF PROCEDURE. RESULTS: THE PATIENT INITIALLY IMPROVED, BUT BECAME HYPOTENSIVE BY THE EVENING OF POSTOPERATIVE DAY 1. HEMOGLOBIN WAS FOUND TO HAVE DROPPED FROM 10.8 TO 7.2 GM/DL (HEMATOCRIT 21.2%, PLATELETS 41 X 10(3)/MCL, PT 25.3 SEC, INR 2.2, AND PTT 59 SEC). REPEAT CT ANGIOGRAPHY (CTA) OF THE ABDOMEN DEMONSTRATED ACTIVE CONTRAST EXTRAVASATION FROM THE PREVIOUSLY EMBOLIZED RIGHT LOBE HEPATIC MASS. REPEAT ANGIOGRAPHY PERFORMED THE MORNING OF POSTOPERATIVE DAY 2 SHOWED NO ACTIVE EXTRAVASATION BUT A PATENT RIGHT HEPATIC ARTERY (FIG. 3). THE RIGHT HEPATIC ARTERY WAS THEN EMBOLIZED TO STASIS WITH 400 UM EMBOZENE SPHERES (BOSTON SCIENTIFIC, MARLBOROUGH MA). FOLLOWING THE SECOND EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY STABLE WITHOUT VASOPRESSOR SUPPORT. HE OPTED FOR PALLIATIVE TREATMENT FOCUSING ON COMFORT AND WAS DISCHARGED TO HOME WITH HOSPICE 10 DAYS AFTER ADMISSION. DISCUSSION/CONCLUSION GELFOAM (DEHYDRATED GELATIN SPONGE) IS A TEMPORARY EMBOLIZATION AGENT DERIVED FROM PURIFIED SKIN GELATIN. GELFOAM RESULTS IN THROMBOSIS BY ACTING AS A MECHANICAL OBSTRUCTION TO BLOOD FLOW; ITS POROUS STRUCTURE CREATES A SCAFFOLD FOR PLATELET AGGREGATION AND CLOT FORMATION. GELFOAM EMBOLIZATION WAS FIRST REPORTED IN 1964 IN A CAVERNOUS CAROTID FISTULA, AND IN SUBSEQUENT PUBLISHED CASE REPORTS IN 1971 AND 1972, WAS USED IN COMBINATION WITH OTHER EMBOLIC AGENTS, SUCH AS MUSCLE, FOR EMBOLIZATION OF SPINAL AND OTHER CNS VASCULAR MALFORMATIONS. USES EXPANDED IN THE 1970S AND 1980S, WITH USE IN INTRA-ABDOMINAL AND INTRAPELVIC HEMORRHAGE, IN MALIGNANCY-ASSOCIATED HEMORRHAGE AND TRAUMATIC INJURY. GELFOAM IS CURRENTLY COMMONLY USED IN TRAUMA. WHILE BELIEVED TO PROVIDE TEMPORARY VESSEL OCCLUSION, THERE IS LIMITED LITERATURE ON THE DURATION OF VESSEL OCCLUSION PRODUCED BY GELFOAM. IN 1977, BARTH ET AL. STUDIED TEMPORARY EMBOLIZATION AGENTS, COMPARING FRESH AUTOLOGOUS CLOT, OXYCEL, AND GELFOAM IN SWINE. TRANSCATHETER EMBOLIZATION OF THE DISTAL GASTROSPLENIC ARTERY AND THE DISTAL RIGHT RENAL ARTERY WAS PERFORMED. REPEAT ANGIOGRAPHY AT 4 MONTHS DEMONSTRATED NO TRACE OF GELFOAM OR ANY OF THE OTHER EMBOLIZATION AGENTS. IN 1981, SNIDERMAN ET AL. COMPARED GELFOAM AND AVITENE (DAVOL, INC., WOBURN, MA) EMBOLIZATION WITH OR WITHOUT SOTRADECOL (MYLAN TEORANTA, GALWAY, IRELAND); THEY PERFORMED EMBOLIZATION OF THE PROFUNDA FEMORIS ARTERIES IN DOGS. AT 2 WEEKS, THE VESSELS EMBOLIZED WITH GELFOAM ALONE HAD COMPLETELY RECANALIZED. IN 2017, OISHI ET AL. PERFORMED GELFOAM EMBOLIZATION VIA MICROCATHETER OF THE LEFT HEPATIC ARTERY IN NORMAL BEAGLE DOGS; AT 2 WEEKS POSTPROCEDURE, CT FINDINGS WERE CONSISTENT WITH RECANALIZATION. THESE STUDIES REPORTED THAT ARTERIES OCCLUDED WITH GELFOAM CAN BE PATENT AT 2 WEEKS, HOWEVER, SHORTER TIME PERIODS WERE NOT STUDIED. IN OUR PATIENT, THE TARGET ARTERY WAS SUCCESSFULLY OCCLUDED WITH GELFOAM; HOWEVER, THE PATIENT RE-BLED FROM THE SAME VESSEL. FOLLOW-UP ANGIOGRAPHY 2 DAYS AFTER INITIAL EMBOLIZATION SHOWED COMPLETE RECANALIZATION OF THE PREVIOUSLY OCCLUDED RIGHT HEPATIC ARTERY. REPEAT EMBOLIZATION WITH A MORE PERMANENT AGENT WAS NEEDED TO OBTAIN HEMOSTASIS. OUR EXPERIENCE SUGGESTS VESSEL OCCLUSION WITH GELFOAM MAY LAST CONSIDERABLY LESS THAN 2 WEEKS, AND MAY NOT BE AS DURABLE AS IS SOMETIMES NEEDED. A DEGREE OF SUSPICION FOR REBLEEDING SHOULD BE MAINTAINED EVEN AFTER SUCCESSFUL VESSEL OCCLUSION WITH GELFOAM. FIG. 1 - INITIAL ANGIOGRAM - PRE-EMBOLIZATION, SHOWING BLEED FROM TUMOR BRANCHES. FIG. 2 - POST-GELFOAM EMBOLIZATION ANGIOGRAM, SHOWING PRUNING OF THE HEPATIC ARTERY WITH NO PERSISTENT EXTRAVASATION. FIG. 3 - REPEAT ANGIOGRAM, SHOWING RECANALIZATION OF THE HEPATIC ARTERY WITHOUT ACTIVE EXTRAVASATION. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 06JUN2023 FOR ABSORBABLE GELATIN: (PARENT) UDI-(IF APPL): 10300100000000. QA REVIEW & RATIONALE: THE HAZARD ANALYSIS WITHIN THE RISK MANAGEMENT FILE HAS BEEN REVIEWED USING THE COMPLIANT NARRATIVE AND ASSOCIATED DOCUMENTATION FOR HAZARDS/HAZARDOUS SITUATIONS, AND THEIR ASSOCIATED SEVERITIES. THE REVIEW DETERMINED THAT THE WORST-CASE SEVERITY WAS S5. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REQUIRING ESCALATION. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE. THE COMPLAINT AND ITS CLASSIFICATION HAVE BEEN REVIEWED AND IT WAS DETERMINED THAT OUR CONTAINMENT ACTION IS A NOTIFICATION TO MANAGEMENT. A FULL INVESTIGATION WILL BE PERFORMED. THIS IS A COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM. THE INVESTIGATION WILL INCLUDE A REVIEW OF COMPLAINTS WITH KNOWN BATCH NUMBERS DETERMINED TO BE WITHIN SCOPE. INVESTIGATION FINDINGS: SUMMARY OF INVESTIGATION: A PERFORMANCE NOT AS INDICATED IN LABEL COMPLAINT WAS RECEIVED FOR AN UNKNOWN LOT OF GELFOAM. 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. REGULATORY/ MARKET ASSESSMENT: ROOT CAUSE ANALYSIS/IDENTIF: PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER KALAMAZOO SITE. IMPACT ANALYSIS: THE WORST-CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S5. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, THE FINAL DETERMINED SCOPE AND THE INABILITY TO DETERMINE A ROOT CAUSE FOR THE REPORTED COMPLAINT, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE IS NO IMPACT TO THE QUALITY OF THE LOT. IMPROVE/CONTROL: CORRECTIVE /PREVENTIVE ACTION: INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE KALAMAZOO MDCP TEAM FOR REVIEW. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE 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.' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. 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. SCOPE OF COMPL. INVESTIGATION: THE INITIAL SCOPE OF THIS INVESTIGATION IS LIMITED TO A REVIEW OF COMPLAINTS WITH KNOWN BATCH NUMBERS RECEIVED WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL FOR THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED BECAUSE ANY PRODUCT ON THE MARKET WITHIN EXPIRY WOULD BE CAPTURED WITHIN THAT TIMEFRAME. A QUERY OF THE COMPLAINTS DATABASE FOR THE REPORTED PRODUCT, CLASS, AND SUB-LASS CAPTURED THE REQUIRED 5 DATA POINTS FOR THE REPORTED PRODUCT, CLASS, AND SUB-CLASS. OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. THE FINAL SCOPE WAS NOT EXPANDED AS A RESULT OF INVESTIGATION. DEVIATIONS: A REVIEW OF DEVIATIONS, LABORATORY INVESTIGATION REPORTS (LIR), AND CHANGE MANAGEMENT RECORDS COULD NOT BE PERFORMED FOR THE REPORTED COMPLAINT, AS THE BATCH IS UNKNOWN. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH. GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED THROUGH A FILTER WITH NITROGEN TO EXTRUDE THE LARGE, SOLID SPONGE BRICKS. THE BRICKS ARE DRIED, TRIMMED AND SPLIT. THE SPLIT BRICKS ARE THEN MILLED TO FORM POWDER. THE POWDER IS COLLECTED IN HIGH DENSITY POLYETHYLENE BAGS AND THEN SEALED INTO BULK CONTAINERS. THE GELFOAM POWDER IS THEN FILLED INTO INNER ENVELOPES USING A POWDER FILLING DEVICE. EACH ENVELOPE IS FILLED WITH A TARGET OF 1.2 GRAMS PER ENVELOPE AND A MINIMUM OF 1.0 GRAM PER ENVELOPE. TWO WEIGHT CHECKS OF EACH POWDER FILLING DEVICE ARE CONDUCTED AT 30-MINUTE INTERVALS TO ASSURE THAT THE DEVICE IS DISPENSING THE PROPER AMOUNT OF POWDER. THE FINAL PRODUCT YIELD IS CALCULATED AGAINST LIMITS FOR THE PRODUCT. THE INNER ENVELOPES ARE FOLDED OVER TWICE AND INSERTED INTO SLEEVES. THE FILLED SLEEVES ARE PLACED INTO TRAYS. THE SLEEVES (PEEL POUCHES) ARE SEALED, AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE ENVELOPES HAVE THE PROPER APPEARANCE, SEAL AND PRINT, AND ALL NOTED DEFECTIVE PRODUCT IS REMOVED FROM THE LOT PRIOR TO FINAL PACKAGING AND NO OPEN SIDE SEALS WERE OBSERVED. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. FOR GELFOAM SPONGE, THE BILL OF MATERIALS LISTS THE SPECIFIC PRODUCT COMPONENTS AND WEIGHTS REQUIRED FOR THE FORMULATION OF EACH BATCH. ALL MANUFACTURING MIXING SPEEDS, TIMES, AND TEMPERATURES HAVE SPECIFICATION CRITERIA. ALL EXTRUSION PARAMETERS HAVE REQUIRED SPECIFICATIONS. AFTER THE PRODUCT IS EXTRUDED INTO BRICKS, THE BRICKS ARE INSPECTED PRIOR TO BEING SLICED INTO INDIVIDUAL SPONGES. AFTER THE BRICKS ARE SLICED INTO SPONGES, A VISUAL INSPECTION IS PERFORMED FOR CONSISTENCY, UNIFORMITY, SHAPE, AND SIZE AT THE BEGINNING, MIDDLE, AND END OF SHIFTS AND EVERY FOUR HOURS IN BETWEEN. ALL DEFECTIVE SPONGES ARE IDENTIFIED AND REMOVED. THE GELFOAM IS PLACED INTO INNER ENVELOPES AND TRANSFERRED TO THE DOYEN PACKAGING EQUIPMENT TO PACKAGE THE ENVELOPES INTO PEEL POUCHES. THE DOYEN TAKES SIX ENVELOPES PER ROTATION BY SUCTION AND LOADS THEM ONTO A CONVEYER BELT AGAINST AN ALIGNMENT TAB. TWO OPERATORS SIT AT THE DOYEN TO CORRECT ALIGNMENT ISSUES PRIOR TO SEALING. THE FRONT AND BACK PAPERS, WHICH MAKE UP THE OUTER PEEL POUCH, ENCLOSE EACH INDIVIDUAL INNER ENVELOPE ENTIRELY WITH A FOUR-SIDED, HEAT-ACTIVATED ADHESIVE SEAL. THE TOP, BOTTOM, AND SIDES OF THE OUTER PEEL POUCHES ARE SEALED BY THREE DIFFERENT PARTS OF THE DOYEN WHICH EACH HAVE SEPARATE TEMPERATURE CONTROLS. EACH TEMPERATURE CONTROL IS VERIFIED AND DOCUMENTED IN THE BATCH RECORD. THE PEEL POUCHES ARE SEALED, AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE PEEL POUCHES HAVE THE PROPER APPEARANCE, SEAL AND PRINT. A SEAL INTEGRITY TEST (SIT) IS UTILIZED THROUGHOUT THE FINAL PACKAGING TO ENSURE THE SIDE SEALS OF THE PEEL POUCHES ARE ACCEPTABLE. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. AUDITS ARE PERFORMED ON THE FINISHED PACKAGED UNITS AT REGULAR INTERVALS THROUGHOUT THE FINAL PACKAGING PROCESS. PROCESS CONTROL EVALUATION: 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 ARE REVIEWED PRIOR TO RELEASE FOR DISTRIBUTION. THE EXISTING PROCESS CONTROLS ARE APPROPRIATE AND ACCEPTABLE; MEDICAL DEVICE QOP NOTIFICATION IS NOT REQUIRED. APRR REVIEW: A REVIEW OF APRR FOR THE PRODUCTS AND TIMEFRAME IN SCOPE DID NOT FIND ANY ISSUE RELATING TO THE REPORTED COMPLAINT. QO BATCH HISTORY REPORT: A REVIEW OF RELEASE TESTING RESULTS COULD NOT BE PERFORMED AS THE REPORTED COMPLAINT BATCH IS UNKNOWN. FOLLOW-UP (06JUN2023): THIS IS A LITERATURE FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. UDI NUMBER ADDED. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON AVAILABLE INFORMATION, A POSSIBLE CONTRIBUTORY ROLE OF SUBJECT PRODUCT GELFOAM CANNOT BE EXCLUDED FOR THE REPORTED EVENTS, BASED ON TEMPORAL RELATIONSHIP . THERE IS LIMITED INFORMATION PROVIDED IN THIS REPORT.THIS CASE WILL BE REASSESSED UPON RECEIPT OF FOLLOW-UP INFORMATION. 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] . THE TARGET ARTERY WAS SUCCESSFULLY OCCLUDED WITH GELFOAM; HOWEVER, THE PATIENT RE-BLED FROM THE SAME VESSEL [OFF LABEL USE], THE TARGET ARTERY WAS SUCCESSFULLY OCCLUDED WITH GELFOAM; HOWEVER, THE PATIENT RE-BLED FROM THE SAME VESSEL [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE: "SHORT-INTERVAL RECANALIZATION AFTER GELFOAM OCCLUSION", RADIOLOGY CASE REPORTS, 2022; VOL:17, PGS:3835-3837, DOI:10.1016/J.RADCR.2022.07.002. BACKGROUND: GELFOAM (PFIZER, NEW YORK, NY) IS A TEMPORARY VASCULAR EMBOLIZATION AGENT, BUT THE DURATION OF SUBSEQUENT VESSEL OCCLUSION IS UNCLEAR AS FEW PATIENTS HAVE REPEAT ANGIOGRAPHY FOLLOWING GELFOAM EMBOLIZATION. BEGINNING IN THE 1970S, CONTROL OF TRAUMATIC ARTERIAL HEMORRHAGE UTILIZING GELFOAM HAS BEEN REPORTED. WE REPORT A CASE OF RECANALIZATION OF AN OCCLUDED RIGHT HEPATIC ARTERY LESS THAN 48 HOURS AFTER TRANSCATHETER EMBOLIZATION WITH GELFOAM SLURRY. METHODS: THE PATIENT, A 66-YEAR-OLD MALE, HAD A PAST MEDICAL HISTORY INCLUDING CIRRHOSIS SECONDARY TO ALCOHOL USE AND CHRONIC HEPATITIS B. HE INITIALLY PRESENTED TO AN OUTSIDE HOSPITAL WITH A 1-2 DAY HISTORY OF FATIGUE, MALAISE, AND GENERALIZED WEAKNESS. HE COMPLAINED OF RIGHT-UPPER-QUADRANT ABDOMINAL PAIN AND INCREASING ABDOMINAL DISTENTION. A PERITONEAL ASPIRATE WAS OBTAINED WHICH WAS FRANKLY BLOODY AND THE PATIENT WAS STARTED EMPIRICALLY ON ANTIBIOTICS FOR SPONTANEOUS BACTERIAL PERITONITIS (SBP). HE BECAME HYPOTENSIVE (SYSTOLIC BLOOD PRESSURES IN THE 60-70 MMHG RANGE) AND WAS VOLUME RESUSCITATED WITH INTRAVENOUS FLUIDS. A CT OF THE ABDOMEN AND PELVIS WAS PERFORMED, WHICH DEMONSTRATED MULTIPLE LIVER MASSES AND LARGE VOLUME HEMOPERITONEUM CONSISTENT WITH SPONTANEOUS RUPTURE OF RIGHT HEPATIC LOBE HEPATOCELLULAR CARCINOMA. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT UNDER THE TRAUMA SURGICAL SERVICE AT OUR INSTITUTION, AND INTERVENTIONAL RADIOLOGY (IR) WAS CONSULTED FOR HEPATIC ANGIOGRAPHY AND POSSIBLE EMBOLIZATION. AT THE TIME OF TRANSFER, HEMOGLOBIN WAS 9.3 GM/DL (BASELINE OF 12.6), HEMATOCRIT 28.8%, PLATELETS 138 X 10(3)/MCL, PROTHROMBIN TIME (PT) 19.4 SEC, INTERNATIONAL NORMALIZED RATIO (INR) 1.7, AND PARTIAL THROMBOPLASTIN TIME (PTT) 40 SEC. AFTER OBTAINING RIGHT COMMON FEMORAL ARTERY ACCESS, THE CELIAC AXIS WAS SELECTED WITH A 5-FR SOS CATHETER (ANGIODYNAMICS, QUEENSBURY, NY). A 3-FR HIGH FLOW RENEGADE CATHETER (BOSTON SCIENTIFIC, MARLBOROUGH, MA) AND A 0.018 GUIDE WIRE WERE USED TO SELECT THE PROPER HEPATIC ARTERY. ANGIOGRAPHY SHOWED TUMOR VASCULARITY IN THE RIGHT LOBE OF THE LIVER WITH 2 FOCI OF ACTIVE EXTRAVASATION. THE 3-FR CATHETER AND 0.018 WIRE WERE USED TO SUBSELECT THE RIGHT HEPATIC ARTERY (FIG. 1). THROUGH THE 3-FR MICROCATHETER, GELFOAM SLURRY (ONE GELFOAM SHEET CUT, SUSPENDED IN 20 ML OF 50% OMNIPAQUE 350 AND 50% NORMAL SALINE, IRRIGATED THROUGH A 3-WAY STOP-COCK 50 TIMES) WAS INJECTED TO 5-BEAT STASIS (FIG. 2). THE ANGIOGRAPHY WAS COMPLETED BY THE AFTERNOON OF DAY OF PROCEDURE. RESULTS: THE PATIENT INITIALLY IMPROVED, BUT BECAME HYPOTENSIVE BY THE EVENING OF POSTOPERATIVE DAY 1. HEMOGLOBIN WAS FOUND TO HAVE DROPPED FROM 10.8 TO 7.2 GM/DL (HEMATOCRIT 21.2%, PLATELETS 41 X 10(3)/MCL, PT 25.3 SEC, INR 2.2, AND PTT 59 SEC). REPEAT CT ANGIOGRAPHY (CTA) OF THE ABDOMEN DEMONSTRATED ACTIVE CONTRAST EXTRAVASATION FROM THE PREVIOUSLY EMBOLIZED RIGHT LOBE HEPATIC MASS. REPEAT ANGIOGRAPHY PERFORMED THE MORNING OF POSTOPERATIVE DAY 2 SHOWED NO ACTIVE EXTRAVASATION BUT A PATENT RIGHT HEPATIC ARTERY (FIG. 3). THE RIGHT HEPATIC ARTERY WAS THEN EMBOLIZED TO STASIS WITH 400 UM EMBOZENE SPHERES (BOSTON SCIENTIFIC, MARLBOROUGH MA). FOLLOWING THE SECOND EMBOLIZATION, THE PATIENT REMAINED HEMODYNAMICALLY STABLE WITHOUT VASOPRESSOR SUPPORT. HE OPTED FOR PALLIATIVE TREATMENT FOCUSING ON COMFORT AND WAS DISCHARGED TO HOME WITH HOSPICE 10 DAYS AFTER ADMISSION. DISCUSSION/CONCLUSION GELFOAM (DEHYDRATED GELATIN SPONGE) IS A TEMPORARY EMBOLIZATION AGENT DERIVED FROM PURIFIED SKIN GELATIN. GELFOAM RESULTS IN THROMBOSIS BY ACTING AS A MECHANICAL OBSTRUCTION TO BLOOD FLOW; ITS POROUS STRUCTURE CREATES A SCAFFOLD FOR PLATELET AGGREGATION AND CLOT FORMATION. GELFOAM EMBOLIZATION WAS FIRST REPORTED IN 1964 IN A CAVERNOUS CAROTID FISTULA, AND IN SUBSEQUENT PUBLISHED CASE REPORTS IN 1971 AND 1972, WAS USED IN COMBINATION WITH OTHER EMBOLIC AGENTS, SUCH AS MUSCLE, FOR EMBOLIZATION OF SPINAL AND OTHER CNS VASCULAR MALFORMATIONS. USES EXPANDED IN THE 1970S AND 1980S, WITH USE IN INTRA-ABDOMINAL AND INTRAPELVIC HEMORRHAGE, IN MALIGNANCY-ASSOCIATED HEMORRHAGE AND TRAUMATIC INJURY. GELFOAM IS CURRENTLY COMMONLY USED IN TRAUMA. WHILE BELIEVED TO PROVIDE TEMPORARY VESSEL OCCLUSION, THERE IS LIMITED LITERATURE ON THE DURATION OF VESSEL OCCLUSION PRODUCED BY GELFOAM. IN 1977, BARTH ET AL. STUDIED TEMPORARY EMBOLIZATION AGENTS, COMPARING FRESH AUTOLOGOUS CLOT, OXYCEL, AND GELFOAM IN SWINE. TRANSCATHETER EMBOLIZATION OF THE DISTAL GASTROSPLENIC ARTERY AND THE DISTAL RIGHT RENAL ARTERY WAS PERFORMED. REPEAT ANGIOGRAPHY AT 4 MONTHS DEMONSTRATED NO TRACE OF GELFOAM OR ANY OF THE OTHER EMBOLIZATION AGENTS. IN 1981, SNIDERMAN ET AL. COMPARED GELFOAM AND AVITENE (DAVOL, INC., WOBURN, MA) EMBOLIZATION WITH OR WITHOUT SOTRADECOL (MYLAN TEORANTA, GALWAY, IRELAND); THEY PERFORMED EMBOLIZATION OF THE PROFUNDA FEMORIS ARTERIES IN DOGS. AT 2 WEEKS, THE VESSELS EMBOLIZED WITH GELFOAM ALONE HAD COMPLETELY RECANALIZED. IN 2017, OISHI ET AL. PERFORMED GELFOAM EMBOLIZATION VIA MICROCATHETER OF THE LEFT HEPATIC ARTERY IN NORMAL BEAGLE DOGS; AT 2 WEEKS POSTPROCEDURE, CT FINDINGS WERE CONSISTENT WITH RECANALIZATION. THESE STUDIES REPORTED THAT ARTERIES OCCLUDED WITH GELFOAM CAN BE PATENT AT 2 WEEKS, HOWEVER, SHORTER TIME PERIODS WERE NOT STUDIED. IN OUR PATIENT, THE TARGET ARTERY WAS SUCCESSFULLY OCCLUDED WITH GELFOAM; HOWEVER, THE PATIENT RE-BLED FROM THE SAME VESSEL. FOLLOW-UP ANGIOGRAPHY 2 DAYS AFTER INITIAL EMBOLIZATION SHOWED COMPLETE RECANALIZATION OF THE PREVIOUSLY OCCLUDED RIGHT HEPATIC ARTERY. REPEAT EMBOLIZATION WITH A MORE PERMANENT AGENT WAS NEEDED TO OBTAIN HEMOSTASIS. OUR EXPERIENCE SUGGESTS VESSEL OCCLUSION WITH GELFOAM MAY LAST CONSIDERABLY LESS THAN 2 WEEKS, AND MAY NOT BE AS DURABLE AS IS SOMETIMES NEEDED. A DEGREE OF SUSPICION FOR REBLEEDING SHOULD BE MAINTAINED EVEN AFTER SUCCESSFUL VESSEL OCCLUSION WITH GELFOAM. FIG. 1 - INITIAL ANGIOGRAM - PRE-EMBOLIZATION, SHOWING BLEED FROM TUMOR BRANCHES. FIG. 2 - POST-GELFOAM EMBOLIZATION ANGIOGRAM, SHOWING PRUNING OF THE HEPATIC ARTERY WITH NO PERSISTENT EXTRAVASATION. FIG. 3 - REPEAT ANGIOGRAM, SHOWING RECANALIZATION OF THE HEPATIC ARTERY WITHOUT ACTIVE EXTRAVASATION., COMMENT: BASED ON AVAILABLE INFORMATION, A POSSIBLE CONTRIBUTORY ROLE OF SUBJECT PRODUCT GELFOAM CANNOT BE EXCLUDED FOR THE REPORTED EVENTS, BASED ON TEMPORAL RELATIONSHIP . THERE IS LIMITED INFORMATION PROVIDED IN THIS REPORT. THIS CASE WILL BE REASSESSED UPON RECEIPT OF FOLLOW-UP INFORMATION. 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 |
|---|---|---|---|---|---|---|---|
| 1156550 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Required Intervention| L| O |