ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2020-00055
- Event Type
- Injury
- Date Received
- August 12, 2020
- Report Date
- July 28, 2020
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
SITE SAMPLE STATUS WAS NOT RECEIVED. ROOT CAUSE: 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: QUALITY OF LOT: ACCEPTABLE. 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, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION:THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER KALAMAZOO IS NOT REQUIRED. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (JANUARY 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT NEGLIGIBLE/MINOR', AND THERE WERE TWO MONTHS (JANUARY AND APRIL 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 9, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION.
SITE SAMPLE STATUS WAS NOT RECEIVED. ROOT CAUSE: 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: QUALITY OF LOT: ACCEPTABLE. 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, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION:THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER KALAMAZOO IS NOT REQUIRED. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (JANUARY 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT NEGLIGIBLE/MINOR', AND THERE WERE TWO MONTHS (JANUARY AND APRIL 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 9, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. PQC REASONABLY SUGGESTED A DEVICE MALFUNCTION WITH A SEVERITY OF HARM RANKING OF S4. THE SAMPLE HAS NOT BEEN RECEIVED. THE FOLLOWING WAS THE SUMMARY OF INVESTIGATION: BASED ON THE COMPLAINT NARRATIVE THE PATIENT EXPERIENCED LEG PARALYSIS WAS DEVELOPED IMMEDIATELY AFTER AN ARTERY EMBOLIZATION USING A COIL AND GELATIN SPONGE. PFIZER SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE 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 SITE. 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, PGS-QO SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. 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. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE SITE 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. THIS COMPLAINT FOR PARALYSIS IN LEGS POST ARTERIAL EMBOLIZATION USING GELATIN SPONGE FOR ABSORBABLE GELATIN IS REPORTABLE FOR US FOR A SERIOUS INJURY THAT COULD RESULT IN PERMANENT IMPAIRMENT OF THE BODY FUNCTION. THIS EVENT IS REPORTABLE FOR ROW SINCE THIS COULD LEAD TO AN ANTICIPATED SERIOUS DETERIORATION IN HEALTH. THIS IS NOT A MALFUNCTION, HOWEVER IT IS A SERIOUS INJURY FOR BOTH US AND ROW. THIS PRODUCT IS USED FOR TREATMENT. THIS IS A 30-DAY US REPORTABLE AND 15-DAY REPORTABLE FOR ROW. PQC CONCLUDED THAT BASED ON THE COMPLAINT NARRATIVE THE PATIENT EXPERIENCED LEG PARALYSIS WAS DEVELOPED IMMEDIATELY AFTER AN ARTERY EMBOLIZATION USING A COIL AND GELATIN SPONGE. THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO COMPLAINT SAMPLE WAS RECEIVED. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER SITE IS NOT REQUIRED.
EVENT VERBATIM [PREFERRED TERM] LEG PARALYSIS [MONOPLEGIA], ARTERIAL EMBOLIZATION WITH GELATINE SPONGE [OFF LABEL USE], ARTERIAL EMBOLIZATION WITH GELATINE SPONGE [PRODUCT USE IN UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FROM THE JOURNAL OF THE JAPANESE ORTHOPAEDIC ASSOCIATION, 2020, 94(6); S1464 ENTITLED A CASE OF LEG PARALYSIS FROM PREOPERATIVE TAE FOR TES AT THE LEVEL OF THE UPPER THORACIC SPINE. TOTAL EN BLOC SPONDYLECTOMY (TES) REQUIRES A HIGH DEGREE OF TECHNICAL PROFICIENCY. AT TIMES THERE IS MASSIVE BLEEDING, AND THERE HAVE BEEN MANY REPORTS OF CASES WHERE A SERIOUS CONDITION DEVELOPED DURING SURGERY. FOR THIS REASON, MANY FACILITIES PERFORM TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) TO EMBOLIZE THE ARTERY THAT FEEDS THE TUMOUR BEFORE THE OPERATION. THE AUTHORS EXPERIENCED AND HEREIN REPORT A CASE IN WHICH COMPLETE PARALYSIS OF LEGS WAS CAUSED BY PREOPERATIVE TAE. THE PATIENT WAS A 68-YEAR-OLD MAN. HE HAD GRADUALLY BEGUN TO NOTICE A SENSORY DISTURBANCE IN THE ABDOMEN AND THROUGHOUT THE LOWER LIMBS, ALONG WITH DIFFICULTY IN WALKING, STARTING ABOUT ONE MONTH BEFORE, AND HE RECEIVED A WORKUP AT A LOCAL HOSPITAL. AS A RESULT, HE WAS DIAGNOSED WITH THYROID CANCER AND METASTASES TO SPINE (TH3, 4), AND HE WAS TRANSFERRED TO THE AUTHORS' HOSPITAL TO UNDERGO TES. AT THE TIME OF THE TRANSFER, MUSCULAR STRENGTH IN HIS LEGS HAD DECREASED SLIGHTLY, AND HIS MMT LEVEL WAS 4, SO THE AUTHORS PLANNED TO PERFORM SEMI-URGENT SURGERY AT THE AUTHORS' HOSPITAL. THE DEPARTMENT OF RADIOLOGY WAS ASKED TO PERFORM TAE ON THE DAY BEFORE THE OPERATION. TUMOUR STAIN WAS OBSERVED IN INTERCOSTAL ARTERIOGRAPHY OF THE LEFT 5TH AND RIGHT 4TH INTERCOSTAL ARTERIES, AND THE PATIENT COMPLAINED OF WEAKNESS IN HIS LEGS IMMEDIATELY AFTER ARTERIAL EMBOLIZATION WAS PERFORMED WITH A COIL AND GELATINE SPONGE. SINCE AN EXAMINATION BY AN ORTHOPAEDIC SURGEON FOUND COMPLETE PARALYSIS OF THE LEGS, THE TAE WAS INTERRUPTED AT THAT STAGE. THE AUTHORS EXPLAINED TO THE PATIENT THAT IT WAS UNKNOWN WHETHER HE WOULD BE ABLE TO IMPROVE LEG FUNCTION, BUT THE PATIENT STILL WISHED TO UNDERGO THE TES, SO IT WAS PERFORMED AS PLANNED. ALTHOUGH 6 MONTHS HAVE ELAPSED SINCE THE OPERATION, THERE HAS BEEN NO IMPROVEMENT IN THE LEG PARALYSIS, AND THE PATIENT IS NOW UNDERGOING REHABILITATION. THE ARTERY OF ADAMKIEWICZ IS THE 12TH INTERCOSTAL ARTERY, AND IT WAS UNRELATED TO THE SITE OF THE EMBOLIZATION IN THE AUTHORS' CASE. MOREOVER, THE SIZE OF THE EMBOLIC MATERIAL WAS THE MINIMUM, AND MEASURES AGAINST COMPLICATIONS WERE TAKEN. HOWEVER, AS A RESULT COMPLETE PARALYSIS OF THE LEGS DEVELOPED DURING THE TAE PROCEDURE. THE CONCEIVABLE CAUSES INCLUDED SPINAL CORD INFARCTION FROM UNDEPICTED SPINAL BRANCH EMBOLUS, AND SPINAL CORD STRESS FROM CHANGES IN BLOOD FLOW RESULTING FROM TAE, BUT A DEFINITIVE DIAGNOSIS WAS NOT REACHED. THE MARROW OF THE UPPER SPINE HAS BEEN REPORTED TO BE EXTREMELY VULNERABLE TO ISCHAEMIA, AND THE AUTHORS SHOULD BE EXTREMELY CAUTIOUS WHEN DETERMINING WHETHER TAE IS INDICATED AND WHAT TECHNIQUE TO USE IN THE ACTUAL OPERATION WHEN THE AUTHORS ARE DEALING WITH UPPER SPINAL MARROW THAT IS LOSING ITS RESIDUAL FUNCTION IN A PATIENT WHOSE LEGS ARE DECLINING IN MUSCULAR STRENGTH. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES. FOLLOW-UP (18SEP2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATION RESULTS. AN INFORMATION OF "FULL COMPLAINT INVESTIGATION - DETAIL" FROM KALAMAZOO (EP) WAS PROVIDED AS FOLLOWS: SITE SAMPLE STATUS WAS NOT RECEIVED. ROOT CAUSE: 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: QUALITY OF LOT: ACCEPTABLE. 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, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION:THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER KALAMAZOO IS NOT REQUIRED. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (JANUARY 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT NEGLIGIBLE/MINOR', AND THERE WERE TWO MONTHS (JANUARY AND APRIL 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 9, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. COMPANY CLINICAL EVALUATION COMMENT: A COMPLETE PARALYSIS OF THE LEGS DEVELOPED DURING THE TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PROCEDURE. AS STATED BY THE AUTHOR, THE MARROW OF THE UPPER SPINE HAS BEEN REPORTED TO BE EXTREMELY VULNERABLE TO ISCHAEMIA. DUE TO CLOSE TEMPORAL RELATIONSHIP, THE ONSET OF THE EVENT LEG PARALYSIS WAS ASSOCIATED WITH OFF LABEL USE OF ABSORBABLE GELATIN SPONGE FOR TAE. THE CO-SUSPECT PRODUCT COIL MAY HAVE PLAYED THE MOST IMPORTANT ROLE TO THE LONG-LASTING LEG PARALYSIS. 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. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: A COMPLETE PARALYSIS OF THE LEGS DEVELOPED DURING THE TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PROCEDURE. AS STATED BY THE AUTHOR, THE MARROW OF THE UPPER SPINE HAS BEEN REPORTED TO BE EXTREMELY VULNERABLE TO ISCHAEMIA. DUE TO CLOSE TEMPORAL RELATIONSHIP, THE ONSET OF THE EVENT LEG PARALYSIS WAS ASSOCIATED WITH OFF LABEL USE OF ABSORBABLE GELATIN SPONGE FOR TAE. THE CO-SUSPECT PRODUCT COIL MAY HAVE PLAYED THE MOST IMPORTANT ROLE TO THE LONG-LASTING LEG PARALYSIS. 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]. LEG PARALYSIS [MONOPLEGIA], ARTERIAL EMBOLIZATION WITH GELATINE SPONGE [OFF LABEL USE], NARRATIVE: THIS IS A LITERATURE REPORT FROM THE JOURNAL OF THE JAPANESE ORTHOPAEDIC ASSOCIATION, 2020, 94(6); S1464, ENTITLED "A CASE OF LEG PARALYSIS FROM PREOPERATIVE TAE FOR TES AT THE LEVEL OF THE UPPER THORACIC SPINE". TOTAL EN BLOC SPONDYLECTOMY (TES) REQUIRES A HIGH DEGREE OF TECHNICAL PROFICIENCY. AT TIMES THERE IS MASSIVE BLEEDING, AND THERE HAVE BEEN MANY REPORTS OF CASES WHERE A SERIOUS CONDITION DEVELOPED DURING SURGERY. FOR THIS REASON, MANY FACILITIES PERFORM TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) TO EMBOLIZE THE ARTERY THAT FEEDS THE TUMOUR BEFORE THE OPERATION. THE AUTHORS EXPERIENCED AND HEREIN REPORT A CASE IN WHICH COMPLETE PARALYSIS OF LEGS WAS CAUSED BY PREOPERATIVE TAE. THE PATIENT WAS A 68-YEAR-OLD MAN. HE HAD GRADUALLY BEGUN TO NOTICE A SENSORY DISTURBANCE IN THE ABDOMEN AND THROUGHOUT THE LOWER LIMBS, ALONG WITH DIFFICULTY IN WALKING, STARTING ABOUT ONE MONTH BEFORE, AND HE RECEIVED A WORKUP AT A LOCAL HOSPITAL. AS A RESULT, HE WAS DIAGNOSED WITH THYROID CANCER AND METASTASES TO SPINE (TH3, 4), AND HE WAS TRANSFERRED TO THE AUTHORS' HOSPITAL TO UNDERGO TES. AT THE TIME OF THE TRANSFER, MUSCULAR STRENGTH IN HIS LEGS HAD DECREASED SLIGHTLY, AND HIS MMT LEVEL WAS 4, SO THE AUTHORS PLANNED TO PERFORM SEMI-URGENT SURGERY AT THE AUTHORS' HOSPITAL. THE DEPARTMENT OF RADIOLOGY WAS ASKED TO PERFORM TAE ON THE DAY BEFORE THE OPERATION. TUMOUR STAIN WAS OBSERVED IN INTERCOSTAL ARTERIOGRAPHY OF THE LEFT 5TH AND RIGHT 4TH INTERCOSTAL ARTERIES, AND THE PATIENT COMPLAINED OF WEAKNESS IN HIS LEGS IMMEDIATELY AFTER ARTERIAL EMBOLIZATION WAS PERFORMED WITH A COIL AND GELATINE SPONGE. SINCE AN EXAMINATION BY AN ORTHOPAEDIC SURGEON FOUND COMPLETE PARALYSIS OF THE LEGS, THE TAE WAS INTERRUPTED AT THAT STAGE. THE AUTHORS EXPLAINED TO THE PATIENT THAT IT WAS UNKNOWN WHETHER HE WOULD BE ABLE TO IMPROVE LEG FUNCTION, BUT THE PATIENT STILL WISHED TO UNDERGO THE TES, SO IT WAS PERFORMED AS PLANNED. ALTHOUGH 6 MONTHS HAVE ELAPSED SINCE THE OPERATION, THERE HAS BEEN NO IMPROVEMENT IN THE LEG PARALYSIS, AND THE PATIENT IS NOW UNDERGOING REHABILITATION. THE ARTERY OF ADAMKIEWICZ IS THE 12TH INTERCOSTAL ARTERY, AND IT WAS UNRELATED TO THE SITE OF THE EMBOLIZATION IN THE AUTHORS' CASE. MOREOVER, THE SIZE OF THE EMBOLIC MATERIAL WAS THE MINIMUM, AND MEASURES AGAINST COMPLICATIONS WERE TAKEN. HOWEVER, AS A RESULT COMPLETE PARALYSIS OF THE LEGS DEVELOPED DURING THE TAE PROCEDURE. THE CONCEIVABLE CAUSES INCLUDED SPINAL CORD INFARCTION FROM UNDEPICTED SPINAL BRANCH EMBOLUS, AND SPINAL CORD STRESS FROM CHANGES IN BLOOD FLOW RESULTING FROM TAE, BUT A DEFINITIVE DIAGNOSIS WAS NOT REACHED. THE MARROW OF THE UPPER SPINE HAS BEEN REPORTED TO BE EXTREMELY VULNERABLE TO ISCHAEMIA, AND THE AUTHORS SHOULD BE EXTREMELY CAUTIOUS WHEN DETERMINING WHETHER TAE IS INDICATED AND WHAT TECHNIQUE TO USE IN THE ACTUAL OPERATION WHEN THE AUTHORS ARE DEALING WITH UPPER SPINAL MARROW THAT IS LOSING ITS RESIDUAL FUNCTION IN A PATIENT WHOSE LEGS ARE DECLINING IN MUSCULAR STRENGTH. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES. FOLLOW-UP (18SEP2020): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT GROUP INCLUDES INVESTIGATION RESULTS. AN INFORMATION OF "FULL COMPLAINT INVESTIGATION - DETAIL" FROM MANUFACTURING SITE (EP) WAS PROVIDED AS FOLLOWS: SITE SAMPLE STATUS WAS NOT RECEIVED. ROOT CAUSE: PFIZER SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE 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 SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE. 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, PGS-QO SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CONCLUSION:THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER SITE IS NOT REQUIRED. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (JAN2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT NEGLIGIBLE/MINOR', AND THERE WERE TWO MONTHS (JANUARY AND APRIL 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 AND 9, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (07JAN2021): NEW INFORMATION RECEIVED FROM PRODUCT QUALITY COMPLAINT (PQC) GROUP INCLUDES INVESTIGATION RESULTS. THE PRODUCT DESCRIPTION WAS FOR GELFOAM STERILE SPONGE SIZE 12-7 MM X 4 (UNKNOWN LOT NUMBER AND EXPIRATION DATE). PQC REASONABLY SUGGESTED A DEVICE MALFUNCTION WITH A SEVERITY OF HARM RANKING OF S4. THE SAMPLE HAS NOT BEEN RECEIVED. THE FOLLOWING WAS THE SUMMARY OF INVESTIGATION: BASED ON THE COMPLAINT NARRATIVE THE PATIENT EXPERIENCED LEG PARALYSIS WAS DEVELOPED IMMEDIATELY AFTER AN ARTERY EMBOLIZATION USING A COIL AND GELATIN SPONGE. PFIZER SITE QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE 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 SITE. 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, PGS-QO SITE CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. 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. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE SITE 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. THIS COMPLAINT FOR PARALYSIS IN LEGS POST ARTERIAL EMBOLIZATION USING GELATIN SPONGE FOR ABSORBABLE GELATIN IS REPORTABLE FOR US FOR A SERIOUS INJURY THAT COULD RESULT IN PERMANENT IMPAIRMENT OF THE BODY FUNCTION. THIS EVENT IS REPORTABLE FOR ROW SINCE THIS COULD LEAD TO AN ANTICIPATED SERIOUS DETERIORATION IN HEALTH. THIS IS NOT A MALFUNCTION, HOWEVER IT IS A SERIOUS INJURY FOR BOTH US AND ROW. THIS PRODUCT IS USED FOR TREATMENT. THIS IS A 30-DAY US REPORTABLE AND 15-DAY REPORTABLE FOR ROW. PQC CONCLUDED THAT BASED ON THE COMPLAINT NARRATIVE THE PATIENT EXPERIENCED LEG PARALYSIS WAS DEVELOPED IMMEDIATELY AFTER AN ARTERY EMBOLIZATION USING A COIL AND GELATIN SPONGE. THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO COMPLAINT SAMPLE WAS RECEIVED. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER SITE IS NOT REQUIRED. COMPANY CLINICAL EVALUATION COMMENT: A COMPLETE PARALYSIS OF THE LEGS DEVELOPED DURING THE TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PROCEDURE. AS STATED BY THE AUTHOR, THE MARROW OF THE UPPER SPINE HAS BEEN REPORTED TO BE EXTREMELY VULNERABLE TO ISCHAEMIA. DUE TO CLOSE TEMPORAL RELATIONSHIP, THE ONSET OF THE EVENT LEG PARALYSIS WAS ASSOCIATED WITH OFF LABEL USE OF ABSORBABLE GELATIN SPONGE FOR TAE. THE CO-SUSPECT PRODUCT COIL MAY HAVE PLAYED THE MOST IMPORTANT ROLE TO THE LONG-LASTING LEG PARALYSIS. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: A COMPLETE PARALYSIS OF THE LEGS DEVELOPED DURING THE TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PROCEDURE. AS STATED BY THE AUTHOR, THE MARROW OF THE UPPER SPINE HAS BEEN REPORTED TO BE EXTREMELY VULNERABLE TO ISCHAEMIA. DUE TO CLOSE TEMPORAL RELATIONSHIP, THE ONSET OF THE EVENT LEG PARALYSIS WAS ASSOCIATED WITH OFF LABEL USE OF ABSORBABLE GELATIN SPONGE FOR TAE. THE CO-SUSPECT PRODUCT COIL MAY HAVE PLAYED THE MOST IMPORTANT ROLE TO THE LONG-LASTING LEG PARALYSIS. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM] LEG PARALYSIS [MONOPLEGIA], ARTERIAL EMBOLIZATION WITH GELATINE SPONGE [OFF LABEL USE], ARTERIAL EMBOLIZATION WITH GELATINE SPONGE [PRODUCT USE IN UNAPPROVED INDICATION], NARRATIVE: THIS IS A LITERATURE REPORT FROM THE JOURNAL OF THE JAPANESE ORTHOPAEDIC ASSOCIATION, 2020, 94(6); S1464 ENTITLED A CASE OF LEG PARALYSIS FROM PREOPERATIVE TAE FOR TES AT THE LEVEL OF THE UPPER THORACIC SPINE. TOTAL EN BLOC SPONDYLECTOMY (TES) REQUIRES A HIGH DEGREE OF TECHNICAL PROFICIENCY. AT TIMES THERE IS MASSIVE BLEEDING, AND THERE HAVE BEEN MANY REPORTS OF CASES WHERE A SERIOUS CONDITION DEVELOPED DURING SURGERY. FOR THIS REASON, MANY FACILITIES PERFORM TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) TO EMBOLIZE THE ARTERY THAT FEEDS THE TUMOUR BEFORE THE OPERATION. WE EXPERIENCED AND HEREIN REPORT A CASE IN WHICH COMPLETE PARALYSIS OF LEGS WAS CAUSED BY PREOPERATIVE TAE. THE PATIENT WAS A (B)(6) YEAR-OLD MAN. HE HAD GRADUALLY BEGUN TO NOTICE A SENSORY DISTURBANCE IN THE ABDOMEN AND THROUGHOUT THE LOWER LIMBS, ALONG WITH DIFFICULTY IN WALKING, STARTING ABOUT ONE MONTH BEFORE, AND HE RECEIVED A WORKUP AT A LOCAL HOSPITAL. AS A RESULT, HE WAS DIAGNOSED WITH THYROID CANCER AND METASTASES TO SPINE (TH3, 4), AND HE WAS TRANSFERRED TO OUR HOSPITAL TO UNDERGO TES. AT THE TIME OF THE TRANSFER, MUSCULAR STRENGTH IN HIS LEGS HAD DECREASED SLIGHTLY, AND HIS MMT LEVEL WAS 4, SO WE PLANNED TO PERFORM SEMI-URGENT SURGERY AT OUR HOSPITAL. THE DEPARTMENT OF RADIOLOGY WAS ASKED TO PERFORM TAE ON THE DAY BEFORE THE OPERATION. TUMOUR STAIN WAS OBSERVED IN INTERCOSTAL ARTERIOGRAPHY OF THE LEFT 5TH AND RIGHT 4TH INTERCOSTAL ARTERIES, AND THE PATIENT COMPLAINED OF WEAKNESS IN HIS LEGS IMMEDIATELY AFTER ARTERIAL EMBOLIZATION WAS PERFORMED WITH A COIL AND GELATINE SPONGE. SINCE AN EXAMINATION BY AN ORTHOPAEDIC SURGEON FOUND COMPLETE PARALYSIS OF THE LEGS, THE TAE WAS INTERRUPTED AT THAT STAGE. WE EXPLAINED TO THE PATIENT THAT IT WAS UNKNOWN WHETHER HE WOULD BE ABLE TO IMPROVE LEG FUNCTION, BUT THE PATIENT STILL WISHED TO UNDERGO THE TES, SO IT WAS PERFORMED AS PLANNED. ALTHOUGH 6 MONTHS HAVE ELAPSED SINCE THE OPERATION, THERE HAS BEEN NO IMPROVEMENT IN THE LEG PARALYSIS, AND THE PATIENT IS NOW UNDERGOING REHABILITATION. THE ARTERY OF ADAMKIEWICZ IS THE 12TH INTERCOSTAL ARTERY, AND IT WAS UNRELATED TO THE SITE OF THE EMBOLIZATION IN OUR CASE. MOREOVER, THE SIZE OF THE EMBOLIC MATERIAL WAS THE MINIMUM, AND MEASURES AGAINST COMPLICATIONS WERE TAKEN. HOWEVER, AS A RESULT COMPLETE PARALYSIS OF THE LEGS DEVELOPED DURING THE TAE PROCEDURE. THE CONCEIVABLE CAUSES INCLUDED SPINAL CORD INFARCTION FROM UNDEPICTED SPINAL BRANCH EMBOLUS, AND SPINAL CORD STRESS FROM CHANGES IN BLOOD FLOW RESULTING FROM TAE, BUT A DEFINITIVE DIAGNOSIS WAS NOT REACHED. THE MARROW OF THE UPPER SPINE HAS BEEN REPORTED TO BE EXTREMELY VULNERABLE TO ISCHAEMIA, AND WE SHOULD BE EXTREMELY CAUTIOUS WHEN DETERMINING WHETHER TAE IS INDICATED AND WHAT TECHNIQUE TO USE IN THE ACTUAL OPERATION WHEN WE ARE DEALING WITH UPPER SPINAL MARROW THAT IS LOSING ITS RESIDUAL FUNCTION IN A PATIENT WHOSE LEGS ARE DECLINING IN MUSCULAR STRENGTH. COMPANY CLINICAL EVALUATION COMMENT: A COMPLETE PARALYSIS OF THE LEGS DEVELOPED DURING THE TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PROCEDURE. AS STATED BY THE AUTHOR, THE MARROW OF THE UPPER SPINE HAS BEEN REPORTED TO BE EXTREMELY VULNERABLE TO ISCHAEMIA. DUE TO CLOSE TEMPORAL RELATIONSHIP, THE ONSET OF THE EVENT LEG PARALYSIS WAS ASSOCIATED WITH OFF LABEL USE OF ABSORBABLE GELATIN SPONGE FOR TAE. THE CO-SUSPECT PRODUCT COIL MAY HAVE PLAYED THE MOST IMPORTANT ROLE TO THE LONG-LASTING LEG PARALYSIS. 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. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES., COMMENT: A COMPLETE PARALYSIS OF THE LEGS DEVELOPED DURING THE TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) PROCEDURE. AS STATED BY THE AUTHOR, THE MARROW OF THE UPPER SPINE HAS BEEN REPORTED TO BE EXTREMELY VULNERABLE TO ISCHAEMIA. DUE TO CLOSE TEMPORAL RELATIONSHIP, THE ONSET OF THE EVENT LEG PARALYSIS WAS ASSOCIATED WITH OFF LABEL USE OF ABSORBABLE GELATIN SPONGE FOR TAE. THE CO-SUSPECT PRODUCT COIL MAY HAVE PLAYED THE MOST IMPORTANT ROLE TO THE LONG-LASTING LEG PARALYSIS. 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 |
|---|---|---|---|---|---|---|---|
| 864301 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other| R |