GELFOAM
Report
- Report Number
- 1810189-2019-00082
- Event Type
- Injury
- Date Received
- September 18, 2019
- Report Date
- September 2, 2019
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 100 X 6; LOT-#: UNKNOWN. REFERENCE ID NUMBERS: PR ID: 4256868, PR ID: 4256745, PARENT ID: 4193588. (PARENT) UDI-(IF APPL): (B)(4). QA REVIEW & RATIONALE: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. INVESTIGATIONS FINDINGS: SUMMARY OF INVESTIGATION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT. NO LOT-SPECIFIC TREND IDENTIFIED. PARENT SAMPLE STATUS NOT AVAILABLE ON 25OCT2019: SEVERITY OF HARM: UNKNOWN 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 HAZARD/HAZARDOUS SITUATION AND SEVERITY WERE UNKNOWN; THEREFORE, THE COMPLAINT IS INDICATIVE OF A POTENTIALLY REPORTABLE DEVICE COMPLAINT. THE DETAILS OF THE COMPLAINT HAVE BEEN ESCALATED TO PFIZER US SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. ADDITIONALLY, DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE MEDICAL DEVICE COMBINATION PRODUCT (MDCP) TEAM FOR EVALUATION. THE COMPLAINT, ITS PRIORITY, AND ITS CLASSIFICATI...
SEVERITY OF HARM: S3. THE PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 100 X 6; LOT-#: UNKNOWN. REFERENCE ID NUMBERS: PR ID: (B)(4), PR ID: (B)(4), PARENT ID: (B)(4). (PARENT) UDI-(IF APPL): (B)(4).. QA REVIEW & RATIONALE: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. INVESTIGATIONS FINDINGS: SUMMARY OF INVESTIGATION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT. NO LOT-SPECIFIC TREND IDENTIFIED. PARENT SAMPLE STATUS NOT AVAILABLE.
POST-PROCEDURE, THE PATIENT DEVELOPED HEMOPNEUMOTHORAX THAT WAS MANAGED BY SHORT TERM CHEST TUBE [TRAUMATIC HAEMOTHORAX]. CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM RESPIRATORY MEDICINE CASE REPORTS, 2019, VOL 28, ENTITLED "SERIAL TRANSARTERIAL EMBOLIZATION FOR THE MANAGEMENT OF UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA: A CASE REPORT AND REVIEW OF THE LITERATURE." A 37-YEAR-OLD FEMALE PRESENTED TO OUR CANCER CENTER THREE YEARS AGO FOR EVALUATION OF THERAPEUTIC OPTIONS OF UNRESECTABLE PULMONARY HPC. SHE HAS BEEN COMPLAINING OF PROFOUND FATIGUE, RIGHT-SIDED CHEST PAIN, NON-PRODUCTIVE COUGH, UNINTENTIONAL 20 POUND WEIGHT LOSS AND NIGHT SWEATS. HER ONLY PREVIOUS MEDICAL HISTORY WAS AN INCIDENTAL HEART MURMUR DETECTED IN CHILDHOOD. PHYSICAL EXAM WAS UNREMARKABLE WITH THE EXCEPTION OF ABSENT BREATH SOUNDS OVER THE LOWER THIRD OF THE RIGHT HEMITHORAX. DIAGNOSIS WAS PREVIOUSLY MADE WITH CT GUIDED LUNG BIOPSY OF THE THORACIC MASS. HISTOPATHOLOGY REVEALED SPINDLE CELL NEOPLASM WITH OCCASIONAL MITOSES WHICH IS CHARACTERISTIC OF SOLITARY FIBROUS TUMOR/HEMANGIOPERICYTOMA. IMMUNOHISTOCHEMICAL MARKERS WERE STRONGLY POSITIVE FOR CD34, CD99, AND BCL2 AND NEGATIVE FOR KERATIN, CD31, FACTOR VIII, DESMIN, S-100 AND MELANA, CONSISTENT WITH THE DIAGNOSIS OF HEMANGIOPERICYTOMA. CONTRAST ENHANCED CT SCAN OF THE CHEST, ABDOMEN AND PELVIS REVEALED A LARGE 12.4 X 14.0 X 12.5 CM HETEROGENEOUS MASS ON THE ANTERIOR INFERIOR ASPECT OF THE RIGHT HEMITHORAX, NUMEROUS DRAINING VEINS INTO THE LEFT ATRIUM, AND LEFTWARD DEVIATION OF THE MEDIASTINUM CAUSED BY MASS EFFECT. THERE WERE NO SIGNS OF ANY DESTRUCTIVE CHANGES TO THE SURROUNDING RIBS. THE LIVER DEMONSTRATED NUMEROUS ENHANCING LESIONS, THE LARGEST MEASURING 5.6 X 4.6 CM IN THE LEFT HEPATIC LOBE. CT ANGIOGRAPHY SHOWED FEEDER VESSELS FROM THE INFERIOR PHRENIC BRANCH AND INTERCOSTAL VESSELS. ADDITIONAL HYPERVASCULAR MASSES WERE FOUND WITHIN THE LEFT AND RIGHT HEPATIC LOBES. POSITRON EMISSION TOMOGRAPHY (PET) OBTAINED SHOWED NO EVIDENCE OF FLUORODEOXYGLUCOSE (FDG) AVID MALIGNANCY. AFTER MULTIDISCIPLINARY DISCUSSION WITH MEDICAL, RADIATION AND SURGICAL ONCOLOGY, THE TUMOR WAS DEEMED INOPERABLE IN VIEW OF ITS EXTENSIVE VASCULAR BURDEN, RISK OF CATASTROPHIC BLEED AND SPREAD TO THE LIVER. A DECISION TO INITIATE PALLIATIVE CHEMOTHERAPY HAS BEEN DETERMINED. THE PATIENT DID NOT TOLERATE A CHEMOTHERAPY REGIMEN OF TEMOZOLOMIDE AND BEVACIZUMAB DUE TO INTRACTABLE NAUSEA AND VOMITING. TO OFFER LOCAL TUMOUR CONTROL, THE PATIENT UNDERWENT EMBOLIZATION OF THE THORACIC TUMOR FEEDING VESSELS WHICH WERE IDENTIFIED ON ARTERIAL PHASE CT IMAGES AS HYPERTROPHIED ARTERIES. THERE WAS CONCERN FOR NONTARGET EMBOLIZATION WITH EMBOLIZING THESE LARGE BLOOD VESSELS. PRIOR TO EMBOLIZATION, EACH MAJOR TUMOR FEEDING VESSEL IN THE LIVER AND CHEST WAS ASSESSED TO CONFIRM THAT THERE WAS NO LARGE SHUNT. OVERALL, ALTHOUGH THERE WERE MASSIVE DRAINING VEINS, THERE DID NOT SEEM TO BE ANY DIRECT ARTERY TO VEIN SHUNTS THAT WERE NOT AVOIDABLE. INITIAL TAE WAS SUCCESSFULLY PERFORMED ON THE LEFT GASTRIC ARTERY AND RIGHT INFERIOR PHRENIC ARTERY AS WELL AS THE SEGMENT III HEPATIC ARTERY. EMBOLICS USED WERE 40-120, 300-500, 500-700, AND 700-900 MICRON EMBOSPHERES. THESE WERE GIVEN FROM SMALL TO LARGE SEQUENTIALLY UNTIL APPROXIMATELY FIVE HEART BEAT STASIS. ALTHOUGH UNLIKELY THAT THE PULMONARY ARTERY WOULD FEED THIS THORACIC TUMOR ANYWAY, PULMONARY SUPPLY IN FACT WAS CONFIRMED TO NOT BE PRESENT ON CROSS SECTIONAL IMAGING. AS EXPECTED, RECOVERY WAS COMPLICATED BY POSTEMBOLIZATION SYNDROME (PES) THAT REQUIRED HOSPITALIZATION FOR INTRACTABLE NAUSEA AND VOMITING. TWO MONTHS LATER, CT IMAGING OF THE THORAX AND ABDOMEN REVEALED SUCCESSFUL PARTIAL NECROSIS WITH AREAS OF ISCHEMIA WITHIN THE THORACIC MASS ALONG WITH DECREASED SIZE OF THE LIVER LESIONS. HENCE, A SECOND AND THIRD TAE OF THE RIGHT INTERNAL THORACIC ARTERY AND LEFT GASTRIC ARTERY WERE SUBSEQUENTLY PERFORMED FIVE MONTHS APART FOR FURTHER LOCAL TUMOUR CONTROL AND TUMOR NECROSIS. SIX MONTHS FOLLOWING THE LAST TAE, CT SHOWED NEAR COMPLETE REMISSION OF LIVER LESIONS, AND ONLY MINIMAL INCREASE IN THE SIZE OF THE RIGHT THORACIC MASS CRANIOCAUDALLY, MEASURING 19.5 CM AS COMPARED TO PREVIOUSLY 17.7 CM. INCREASED SIZE WAS ATTRIBUTED TO INCREASED NECROTIC FLUID WITHIN THE MASS. THERE WAS A SIMILAR DEGREE OF DRAINING AND SUPPLYING TUMOR VESSLES WITHIN THE ANTERIOR MEDIASTINUM. ALTHOUGH TAE DID NOT LEAD TO COMPLETE REMISSION OF THE TUMOR, HOWEVER, IT PROVIDED LONG TERM CONTROL. CONSEQUENTLY, DECISION HAS BEEN MADE TO INITIATE AN ORAL ANGIOGENESIS INHIBITOR SUNITINIB. PATIENT ELECTED FOR A ONE-YEAR SURVEILLANCE INTERVAL. SUBSEQUENTLY, PET SCAN WAS PERFORMED TO MONITOR DISEASE PROGRESSION. THE THORACIC MASS SHOWED A CURVILINEAR FOCUS OF MILDLY INCREASED FDG UPTAKE ALONG THE SUPERIOR LATERAL ASPECT WITH NO REAL SIGNIFICANT CHANGE OF SIZE. FDG AVID, LOW ATTENUATION OF THE LEFT HEPATIC LOBE LESIONS WERE DEMONSTRATED. CLINICALLY, THE PATIENT WAS THOUGHT TO HAVE DISEASE PROGRESSION AND UNDERWENT THE FOURTH TAE. DURING THE PROCEDURE, SUCCESSFUL BLAND EMBOLIZATION TO SEGMENTS IVA AND IVB LEFT HEPATIC ARTERY BRANCHES, THE RIGHT HEPATIC ARTERY, A BRANCH OF THE INFERIOR PHRENIC ARTERY, THE INFERIOR EPIGASTRIC ARTERY AND THE RIGHT INTERNAL THORACIC ARTERY FOLLOWED BY GELFOAM EMBOLIZATION WERE PERFORMED. THROUGH SONOGRAPHIC GUIDANCE, THE RIGHT FIFTH INTERCOSTAL ARTERY WAS ENTERED, FOLLOWED BY BLAND AND GELFOAM EMBOLIZATION ON THREE DIFFERENT LARGE TUMOR FEEDER DISTRIBUTIONS. POST-PROCEDURE, THE PATIENT DEVELOPED HEMOPNEUMOTHORAX THAT WAS MANAGED BY SHORT TERM CHEST TUBE. TO DATE, THE PATIENT IS BEING FOLLOWED BY THORACIC ONCOLOGY. CONCLUSION THERE ARE LIMITED THERAPEUTIC OPTIONS FOR UNRESECTABLE PULMONARY HPC. THIS CASE HIGHLIGHTS THE POTENTIAL ROLE OF SERIAL TAE COMBINED WITH AN ANGIOGENESIS INHIBITOR IN LONG TERM CONTROL OF THIS DISEASE. FURTHER TRIALS ARE NEEDED TO EXPLORE WHETHER THIS APPROACH IS EFFECTIVE FOR CONTROL OF LOCAL TUMOR AND DISSEMINATED DISEASE. FOLLOW-UP (11SEP2019): THIS IS A FOLLOW-UP REPORT FROM THE PRODUCT QUALITY COMPLAINTS DEPARTMENT (COMPLAINT NUMBER: (B)(4)). A COMPLAINT HAS BEEN RECEIVED BY PFIZER MANUFACTURING SITE WITH NO REASONABLE SUSPICION OF A MALFUNCTION. HAZARDOUS SITUATION, HAZARD NUMBER (WORST CASE), SEVERITY (WORST CASE), AND P2 VALUE: H10-03 (WORST CASE) WERE ALL UNKNOWN. MDR FOR OTHER CASES INVOLVING LITERATURE STUDIES OF THIS TYPE WERE ISSUED PREVIOUSLY THAT WERE NOT ASSOCIATED WITH THIS CASE. FOLLOW-UP (28SEP2019): ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: THE HEMOPNEUMOTHORAX WAS NOT THOUGHT TO BE SECONDARY TO THE GELFOAM. "I CHECKED WITH MY CO-AUTHORS." FOLLOW-UP (02OCT2019 ): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4)), FOR ABSORBABLE GELATIN (GELFOAM). THE PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 100 X 6; LOT-#: UNKNOWN. REFERENCE ID NUMBERS: PR ID: 4256868, PR ID: 4256745, PARENT ID: 4193588. (PARENT) UDI-(IF APPL): (B)(4). QA REVIEW & RATIONALE: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. INVESTIGATIONS FINDINGS: SUMMARY OF INVESTIGATION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. NO LOT-SPECIFIC TREND IDENTIFIED. PARENT SAMPLE STATUS NOT AVAILABLE. AS OF 25OCT2019 SEVERITY OF HARM: UNKNOWN. 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 HAZARD/HAZARDOUS SITUATION AND SEVERITY WERE UNKNOWN; THEREFORE, THE COMPLAINT IS INDICATIVE OF A POTENTIALLY REPORTABLE DEVICE COMPLAINT. THE DETAILS OF THE COMPLAINT HAVE BEEN ESCALATED TO PFIZER US SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. ADDITIONALLY, 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. NO IMMEDIATE CONTAINMENT ACTION IS REQUIRED. AN INVESTIGATION WILL BE PERFORMED. ROOT CAUSE ANALYSIS/IDENTIF: ROOT CAUSE: PFIZER (SITE NAME) QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE (SITE NAME) 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 NAME) SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS UNKNOWN; THEREFORE THE DETAILS OF THE REPORTED COMPLAINT WERE FORWARDED TO PFIZER SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. 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 NAME) CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE / PREVENTIVE ACTION: CORRECTIONS, CORRECTIVE AND PREVENTATIVE ACTIONS: 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 PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF PREVIOUS CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS RELEVANT TO THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. NO PRODUCT QUALITY ISSUES WERE OBSERVED. THE COMPLAINT HAS BEEN ESCALATED TO SAFETY FOR EVALUATION OF REGULATORY REPORTABILITY. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER (SITE NAME) IS NOT REQUIRED. SCOPE OF COMPL. INVESTIGATION: SCOPE: ALL GELFOAM SPONGE AND GELFOAM POWDER BATCHES PRODUCED WITHIN THE 36 MONTHS, THE EXPIRY INTERVAL OF THE PRODUCT, PRIOR TO THE RECEIPT OF THE REPORTED COMPLAINT WERE CONSIDERED TO BE IN SCOPE. A QUERY WITHIN THE COMPLAINTS DATABASE CAPTURED A MINIMUM OF 5 DATA POINTS. THERE WERE NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER DETERMINED TO BE WITHIN SCOPE. 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 AND 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. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. QO BATCH HISTORY REPORT: COMPLETE - ACCEPTABLE. A REVIEW OF BATCH DISPOSITION HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION, AS THERE IS NO KNOWN BATCH NUMBER REPORTED. REFERENCE SAMPLE EXAMINATION: COMPLETE - ACCEPTABLE. AN EXAMINATION OF RETAINED REFERENCE SAMPLES COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, THERE WERE NO PREVIOUSLY INVESTIGATED COMPLAINTS FOR WHICH AN EVALUATION OF PREVIOUS RETAINED REFERENCE SAMPLE EXAMINATIONS COULD BE REVIEWED. LOT TREND ASSMT. & RATIONALE: BATCH SPECIFIC TREND REVIEW: COMPLETE- ACCEPTABLE. THE BATCH NUMBER FOR THE REPORTED COMPLAINT IS UNKNOWN; THEREFORE, AN EVALUATION OF THE BATCH HISTORY COULD NOT BE PERFORMED AS A PART OF THIS INVESTIGATION. OTHER TREND ASSMT. & RATIONALE: MEDICAL DEVICE REPORT REVIEW: A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. PREVIOUS MDR RELEVANT TO THE REPORTED COMPLAINT HAD BEEN ISSUED BY SAFETY; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO PFIZER US AS A REPEATED OCCURRENCE. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. THE COMPLAINT HISTORY FOR PRODUCTS WITH THE PRODUCT CATEGORY DEFINED AS 'ABSORBABLE MATERIAL' AND 'DELIVERY SYSTEM' HAS BEEN REVIEWED. THE FOLLOWING PARAMETERS WERE USED: PRODUCT CATEGORY: ABSORBABLE MATERIAL AND DELIVERY SYSTEM; TIME PERIOD: 03SEP2016-11SEP2019; COMPLAINT CLASSIFICATION: EXTERNAL CAUSE INVESTIGATION; INVESTIGATING SITE: PFIZER KDP. 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 WERE TWO MONTHS (APRIL AND MAY 2019) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS; HOWEVER, THE COMPLAINTS WERE RECEIVED BY PFIZER (SITE NAME) AS A RESULT OF A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION', AND THERE WERE TWO MONTHS (APRIL AND MAY 2019) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS, ALSO AS A RESULT OF THE REMEDIATION BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATIONS. MEDICAL DEVICE COMPONENT TREND: A REVIEW OF TRENDS FOR MEDICAL DEVICE CONSTITUENTS FOR THE REPORTED PRODUCT COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. RETURNED PRODUCT EXAMINATION: PGS (SITE NAME) DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. FOLLOW-UP (24OCT2019): FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. FOLLOW-UP (25OCT2019): NEW INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4)), FOR ABSORBABLE GELATIN (GELFOAM) INCLUDED: SEVERITY OF HARM: UNKNOWN, AND INVESTIGATIONAL RESULT (QA REVIEW & RATIONALE, ROOT CAUSE ANALYSIS/IDENTIF, IMPACT ANALYSIS, CORRECTIVE / PREVENTIVE ACTION, SCOPE OF COMPL. INVESTIGATION, LOT TREND ASSMT. & RATIONALE, OTHER TREND ASSMT. & RATIONALE AND CONCLUSION)., COMMENT: THE UNDERLYING UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA COULD BE THE LEADING CAUSE OF EVENT HEMOPNEUMOTHORAX. AND THE PROCEDURE ITSELF, OPERATION OF TRANSARTERIAL EMBOLIZATION (TAE), COULD BE THE TRIGGER OF THE ONSET OF THE EVENT. CONSIDERING TEMPORAL RELATIONSHIP, A CONTRIBUTION ROLE OF THE USE OF ABSORBABLE GELATIN (GELFOAM) TO THE EVENT CAN NOT BE ENTIRELY EXCLUDED. THE COMPANY CONDUCTED AN INVESTIGATION, AND REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION.
POST-PROCEDURE, THE PATIENT DEVELOPED HEMOPNEUMOTHORAX THAT WAS MANAGED BY SHORT TERM CHEST TUBE [TRAUMATIC HAEMOTHORAX] CASE DESCRIPTION: THIS IS A LITERATURE REPORT FROM THE RESPIRATORY MEDICINE CASE REPORTS, 2019, VOL 28 ENTITLED SERIAL TRANSARTERIAL EMBOLIZATION FOR THE MANAGEMENT OF UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA: A CASE REPORT AND REVIEW OF THE LITERATURE. THIS CASE BELONGS TO A 37-YEAR-OLD FEMALE WHO EXPERIENCED AS HEMOPNEUMOTHORAX WITH SUSPECT DRUG GELFOAM. A 37-YEAR-OLD AFRICAN AMERICAN FEMALE PRESENTED TO OUR CANCER CENTER THREE YEARS AGO FOR EVALUATION OF THERAPEUTIC OPTIONS OF UNRESECTABLE PULMONARY HPC. SHE HAS BEEN COMPLAINING OF PROFOUND FATIGUE, RIGHT-SIDED CHEST PAIN, NON-PRODUCTIVE COUGH, UNINTENTIONAL 20 POUND WEIGHT LOSS AND NIGHT SWEATS. HER ONLY PREVIOUS MEDICAL HISTORY WAS AN INCIDENTAL HEART MURMUR DETECTED IN CHILDHOOD. PHYSICAL EXAM WAS UNREMARKABLE WITH THE EXCEPTION OF ABSENT BREATH SOUNDS OVER THE LOWER THIRD OF THE RIGHT HEMITHORAX. DIAGNOSIS WAS PREVIOUSLY MADE WITH CT GUIDED LUNG BIOPSY OF THE THORACIC MASS. HISTOPATHOLOGY REVEALED SPINDLE CELL NEOPLASM WITH OCCASIONAL MITOSES WHICH IS CHARACTERISTIC OF SOLITARY FIBROUS TUMOR/HEMANGIOPERICYTOMA. IMMUNOHISTOCHEMICAL MARKERS WERE STRONGLY POSITIVE FOR CD34, CD99, AND BCL2 AND NEGATIVE FOR KERATIN, CD31, FACTOR VIII, DESMIN, S-100 AND MELANA, CONSISTENT WITH THE DIAGNOSIS OF HEMANGIOPERICYTOMA. CONTRAST ENHANCED CT SCAN OF THE CHEST, ABDOMEN AND PELVIS REVEALED A LARGE 12.4 X 14.0 X 12.5 CM HETEROGENEOUS MASS ON THE ANTERIOR INFERIOR ASPECT OF THE RIGHT HEMITHORAX, NUMEROUS DRAINING VEINS INTO THE LEFT ATRIUM, AND LEFTWARD DEVIATION OF THE MEDIASTINUM CAUSED BY MASS EFFECT. THERE WERE NO SIGNS OF ANY DESTRUCTIVE CHANGES TO THE SURROUNDING RIBS. THE LIVER DEMONSTRATED NUMEROUS ENHANCING LESIONS, THE LARGEST MEASURING 5.6 X 4.6 CM IN THE LEFT HEPATIC LOBE. CT ANGIOGRAPHY SHOWED FEEDER VESSELS FROM THE INFERIOR PHRENIC BRANCH AND INTERCOSTAL VESSELS. ADDITIONAL HYPERVASCULAR MASSES WERE FOUND WITHIN THE LEFT AND RIGHT HEPATIC LOBES. POSITRON EMISSION TOMOGRAPHY (PET) OBTAINED SHOWED NO EVIDENCE OF FLUORODEOXYGLUCOSE (FDG) AVID MALIGNANCY. AFTER MULTIDISCIPLINARY DISCUSSION WITH MEDICAL, RADIATION AND SURGICAL ONCOLOGY, THE TUMOR WAS DEEMED INOPERABLE IN VIEW OF ITS EXTENSIVE VASCULAR BURDEN, RISK OF CATASTROPHIC BLEED AND SPREAD TO THE LIVER. A DECISION TO INITIATE PALLIATIVE CHEMOTHERAPY HAS BEEN DETERMINED. THE PATIENT DID NOT TOLERATE A CHEMOTHERAPY REGIMEN OF TEMOZOLOMIDE AND BEVACIZUMAB DUE TO INTRACTABLE NAUSEA AND VOMITING TO OFFER LOCAL TUMOUR CONTROL, THE PATIENT UNDERWENT EMBOLIZATION OF THE THORACIC TUMOR FEEDING VESSELS WHICH WERE IDENTIFIED ON ARTERIAL PHASE CT IMAGES AS HYPERTROPHIED ARTERIES. THERE WAS CONCERN FOR NONTARGET EMBOLIZATION WITH EMBOLIZING THESE LARGE BLOOD VESSELS. PRIOR TO EMBOLIZATION, EACH MAJOR TUMOR FEEDING VESSEL IN THE LIVER AND CHEST WAS ASSESSED TO CONFIRM THAT THERE WAS NO LARGE SHUNT. OVERALL, ALTHOUGH THERE WERE MASSIVE DRAINING VEINS, THERE DID NOT SEEM TO BE ANY DIRECT ARTERY TO VEIN SHUNTS THAT WERE NOT AVOIDABLE. INITIAL TAE WAS SUCCESSFULLY PERFORMED ON THE LEFT GASTRIC ARTERY AND RIGHT INFERIOR PHRENIC ARTERY AS WELL AS THE SEGMENT III HEPATIC ARTERY. EMBOLICS USED WERE 40-120, 300-500, 500-700, AND 700-900 MICRON EMBOSPHERES. THESE WERE GIVEN FROM SMALL TO LARGE SEQUENTIALLY UNTIL APPROXIMATELY FIVE HEART BEAT STASIS. ALTHOUGH UNLIKELY THAT THE PULMONARY ARTERY WOULD FEED THIS THORACIC TUMOR ANYWAY, PULMONARY SUPPLY IN FACT WAS CONFIRMED TO NOT BE PRESENT ON CROSS SECTIONAL IMAGING. AS EXPECTED, RECOVERY WAS COMPLICATED BY POSTEMBOLIZATION SYNDROME (PES) THAT REQUIRED HOSPITALIZATION FOR INTRACTABLE NAUSEA AND VOMITING. TWO MONTHS LATER, CT IMAGING OF THE THORAX AND ABDOMEN REVEALED SUCCESSFUL PARTIAL NECROSIS WITH AREAS OF ISCHEMIA WITHIN THE THORACIC MASS ALONG WITH DECREASED SIZE OF THE LIVER LESIONS. HENCE, A SECOND AND THIRD TAE OF THE RIGHT INTERNAL THORACIC ARTERY AND LEFT GASTRIC ARTERY WERE SUBSEQUENTLY PERFORMED FIVE MONTHS APART FOR FURTHER LOCAL TUMOUR CONTROL AND TUMOR NECROSIS. SIX MONTHS FOLLOWING THE LAST TAE, CT SHOWED NEAR COMPLETE REMISSION OF LIVER LESIONS, AND ONLY MINIMAL INCREASE IN THE SIZE OF THE RIGHT THORACIC MASS CRANIOCAUDALLY, MEASURING 19.5 CM AS COMPARED TO PREVIOUSLY 17.7 CM. INCREASED SIZE WAS ATTRIBUTED TO INCREASED NECROTIC FLUID WITHIN THE MASS. THERE WAS A SIMILAR DEGREE OF DRAINING AND SUPPLYING TUMOR VESSLES WITHIN THE ANTERIOR MEDIASTINUM. ALTHOUGH TAE DID NOT LEAD TO COMPLETE REMISSION OF THE TUMOR, HOWEVER, IT PROVIDED LONG TERM CONTROL. CONSEQUENTLY, DECISION HAS BEEN MADE TO INITIATE AN ORAL ANGIOGENESIS INHIBITOR SUNITINIB. PATIENT ELECTED FOR A ONE-YEAR SURVEILLANCE INTERVAL. SUBSEQUENTLY, PET SCAN WAS PERFORMED TO MONITOR DISEASE PROGRESSION. THE THORACIC MASS SHOWED A CURVILINEAR FOCUS OF MILDLY INCREASED FDG UPTAKE ALONG THE SUPERIOR LATERAL ASPECT WITH NO REAL SIGNIFICANT CHANGE OF SIZE. FDG AVID, LOW ATTENUATION OF THE LEFT HEPATIC LOBE LESIONS WERE DEMONSTRATED. CLINICALLY, THE PATIENT WAS THOUGHT TO HAVE DISEASE PROGRESSION AND UNDERWENT THE FOURTH TAE. DURING THE PROCEDURE, SUCCESSFUL BLAND EMBOLIZATION TO SEGMENTS IVA AND IVB LEFT HEPATIC ARTERY BRANCHES, THE RIGHT HEPATIC ARTERY, A BRANCH OF THE INFERIOR PHRENIC ARTERY, THE INFERIOR EPIGASTRIC ARTERY AND THE RIGHT INTERNAL THORACIC ARTERY FOLLOWED BY GELFOAM EMBOLIZATION WERE PERFORMED. THROUGH SONOGRAPHIC GUIDANCE, THE RIGHT FIFTH INTERCOSTAL ARTERY WAS ENTERED, FOLLOWED BY BLAND AND GELFOAM EMBOLIZATION ON THREE DIFFERENT LARGE TUMOR FEEDER DISTRIBUTIONS. POST-PROCEDURE, THE PATIENT DEVELOPED HEMOPNEUMOTHORAX THAT WAS MANAGED BY SHORT TERM CHEST TUBE. TO DATE, THE PATIENT IS BEING FOLLOWED BY THORACIC ONCOLOGY. CONCLUSION THERE ARE LIMITED THERAPEUTIC OPTIONS FOR UNRESECTABLE PULMONARY HPC. THIS CASE HIGHLIGHTS THE POTENTIAL ROLE OF SERIAL TAE COMBINED WITH AN ANGIOGENESIS INHIBITOR IN LONG TERM CONTROL OF THIS DISEASE. FURTHER TRIALS ARE NEEDED TO EXPLORE WHETHER THIS APPROACH IS EFFECTIVE FOR CONTROL OF LOCAL TUMOR AND DISSEMINATED DISEASE. COMMENT: THE UNDERLYING UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA COULD THE LEADING CAUSE OF EVENT HEMOPNEUMOTHORAX. AND THE PROCEDURE ITSELF, OPERATION OF TRANSARTERIAL EMBOLIZATION (TAE), COULD BE THE TRIGGER OF THE ONSET OF THE EVENT. CONSIDERING TEMPORAL RELATIONSHIP, A CONTRIBUTION ROLE OF THE USE OF ABSORBABLE GELATIN (GELFOAM)TO THE EVENT CAN NOT BE ENTIRELY EXCLUDED. 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] POST-PROCEDURE, THE PATIENT DEVELOPED HEMOPNEUMOTHORAX THAT WAS MANAGED BY SHORT TERM CHEST TUBE [TRAUMATIC HAEMOTHORAX]. CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM RESPIRATORY MEDICINE CASE REPORTS, 2019, VOL 28, ENTITLED "SERIAL TRANSARTERIAL EMBOLIZATION FOR THE MANAGEMENT OF UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA: A CASE REPORT AND REVIEW OF THE LITERATURE". A 37-YEAR-OLD AFRICAN AMERICAN FEMALE PRESENTED TO OUR CANCER CENTER THREE YEARS AGO FOR EVALUATION OF THERAPEUTIC OPTIONS OF UNRESECTABLE PULMONARY HPC. SHE HAS BEEN COMPLAINING OF PROFOUND FATIGUE, RIGHT-SIDED CHEST PAIN, NON-PRODUCTIVE COUGH, UNINTENTIONAL 20 POUND WEIGHT LOSS AND NIGHT SWEATS. HER ONLY PREVIOUS MEDICAL HISTORY WAS AN INCIDENTAL HEART MURMUR DETECTED IN CHILDHOOD. PHYSICAL EXAM WAS UNREMARKABLE WITH THE EXCEPTION OF ABSENT BREATH SOUNDS OVER THE LOWER THIRD OF THE RIGHT HEMITHORAX. DIAGNOSIS WAS PREVIOUSLY MADE WITH CT GUIDED LUNG BIOPSY OF THE THORACIC MASS. HISTOPATHOLOGY REVEALED SPINDLE CELL NEOPLASM WITH OCCASIONAL MITOSES WHICH IS CHARACTERISTIC OF SOLITARY FIBROUS TUMOR/HEMANGIOPERICYTOMA. IMMUNOHISTOCHEMICAL MARKERS WERE STRONGLY POSITIVE FOR CD34, CD99, AND BCL2 AND NEGATIVE FOR KERATIN, CD31, FACTOR VIII, DESMIN, S-100 AND MELANA, CONSISTENT WITH THE DIAGNOSIS OF HEMANGIOPERICYTOMA. CONTRAST ENHANCED CT SCAN OF THE CHEST, ABDOMEN AND PELVIS REVEALED A LARGE 12.4 X 14.0 X 12.5 CM HETEROGENEOUS MASS ON THE ANTERIOR INFERIOR ASPECT OF THE RIGHT HEMITHORAX, NUMEROUS DRAINING VEINS INTO THE LEFT ATRIUM, AND LEFTWARD DEVIATION OF THE MEDIASTINUM CAUSED BY MASS EFFECT. THERE WERE NO SIGNS OF ANY DESTRUCTIVE CHANGES TO THE SURROUNDING RIBS. THE LIVER DEMONSTRATED NUMEROUS ENHANCING LESIONS, THE LARGEST MEASURING 5.6 X 4.6 CM IN THE LEFT HEPATIC LOBE. CT ANGIOGRAPHY SHOWED FEEDER VESSELS FROM THE INFERIOR PHRENIC BRANCH AND INTERCOSTAL VESSELS. ADDITIONAL HYPERVASCULAR MASSES WERE FOUND WITHIN THE LEFT AND RIGHT HEPATIC LOBES. POSITRON EMISSION TOMOGRAPHY (PET) OBTAINED SHOWED NO EVIDENCE OF FLUORODEOXYGLUCOSE (FDG) AVID MALIGNANCY. AFTER MULTIDISCIPLINARY DISCUSSION WITH MEDICAL, RADIATION AND SURGICAL ONCOLOGY, THE TUMOR WAS DEEMED INOPERABLE IN VIEW OF ITS EXTENSIVE VASCULAR BURDEN, RISK OF CATASTROPHIC BLEED AND SPREAD TO THE LIVER. A DECISION TO INITIATE PALLIATIVE CHEMOTHERAPY HAS BEEN DETERMINED. THE PATIENT DID NOT TOLERATE A CHEMOTHERAPY REGIMEN OF TEMOZOLOMIDE AND BEVACIZUMAB DUE TO INTRACTABLE NAUSEA AND VOMITING. TO OFFER LOCAL TUMOUR CONTROL, THE PATIENT UNDERWENT EMBOLIZATION OF THE THORACIC TUMOR FEEDING VESSELS WHICH WERE IDENTIFIED ON ARTERIAL PHASE CT IMAGES AS HYPERTROPHIED ARTERIES. THERE WAS CONCERN FOR NONTARGET EMBOLIZATION WITH EMBOLIZING THESE LARGE BLOOD VESSELS. PRIOR TO EMBOLIZATION, EACH MAJOR TUMOR FEEDING VESSEL IN THE LIVER AND CHEST WAS ASSESSED TO CONFIRM THAT THERE WAS NO LARGE SHUNT. OVERALL, ALTHOUGH THERE WERE MASSIVE DRAINING VEINS, THERE DID NOT SEEM TO BE ANY DIRECT ARTERY TO VEIN SHUNTS THAT WERE NOT AVOIDABLE. INITIAL TAE WAS SUCCESSFULLY PERFORMED ON THE LEFT GASTRIC ARTERY AND RIGHT INFERIOR PHRENIC ARTERY AS WELL AS THE SEGMENT III HEPATIC ARTERY. EMBOLICS USED WERE 40-120, 300-500, 500-700, AND 700-900 MICRON EMBOSPHERES. THESE WERE GIVEN FROM SMALL TO LARGE SEQUENTIALLY UNTIL APPROXIMATELY FIVE HEART BEAT STASIS. ALTHOUGH UNLIKELY THAT THE PULMONARY ARTERY WOULD FEED THIS THORACIC TUMOR ANYWAY, PULMONARY SUPPLY IN FACT WAS CONFIRMED TO NOT BE PRESENT ON CROSS SECTIONAL IMAGING. AS EXPECTED, RECOVERY WAS COMPLICATED BY POSTEMBOLIZATION SYNDROME (PES) THAT REQUIRED HOSPITALIZATION FOR INTRACTABLE NAUSEA AND VOMITING. TWO MONTHS LATER, CT IMAGING OF THE THORAX AND ABDOMEN REVEALED SUCCESSFUL PARTIAL NECROSIS WITH AREAS OF ISCHEMIA WITHIN THE THORACIC MASS ALONG WITH DECREASED SIZE OF THE LIVER LESIONS. HENCE, A SECOND AND THIRD TAE OF THE RIGHT INTERNAL THORACIC ARTERY AND LEFT GASTRIC ARTERY WERE SUBSEQUENTLY PERFORMED FIVE MONTHS APART FOR FURTHER LOCAL TUMOUR CONTROL AND TUMOR NECROSIS. SIX MONTHS FOLLOWING THE LAST TAE, CT SHOWED NEAR COMPLETE REMISSION OF LIVER LESIONS, AND ONLY MINIMAL INCREASE IN THE SIZE OF THE RIGHT THORACIC MASS CRANIOCAUDALLY, MEASURING 19.5 CM AS COMPARED TO PREVIOUSLY 17.7 CM. INCREASED SIZE WAS ATTRIBUTED TO INCREASED NECROTIC FLUID WITHIN THE MASS. THERE WAS A SIMILAR DEGREE OF DRAINING AND SUPPLYING TUMOR VESSLES WITHIN THE ANTERIOR MEDIASTINUM. ALTHOUGH TAE DID NOT LEAD TO COMPLETE REMISSION OF THE TUMOR, HOWEVER, IT PROVIDED LONG TERM CONTROL. CONSEQUENTLY, DECISION HAS BEEN MADE TO INITIATE AN ORAL ANGIOGENESIS INHIBITOR SUNITINIB. PATIENT ELECTED FOR A ONE-YEAR SURVEILLANCE INTERVAL. SUBSEQUENTLY, PET SCAN WAS PERFORMED TO MONITOR DISEASE PROGRESSION. THE THORACIC MASS SHOWED A CURVILINEAR FOCUS OF MILDLY INCREASED FDG UPTAKE ALONG THE SUPERIOR LATERAL ASPECT WITH NO REAL SIGNIFICANT CHANGE OF SIZE. FDG AVID, LOW ATTENUATION OF THE LEFT HEPATIC LOBE LESIONS WERE DEMONSTRATED. CLINICALLY, THE PATIENT WAS THOUGHT TO HAVE DISEASE PROGRESSION AND UNDERWENT THE FOURTH TAE. DURING THE PROCEDURE, SUCCESSFUL BLAND EMBOLIZATION TO SEGMENTS IVA AND IVB LEFT HEPATIC ARTERY BRANCHES, THE RIGHT HEPATIC ARTERY, A BRANCH OF THE INFERIOR PHRENIC ARTERY, THE INFERIOR EPIGASTRIC ARTERY AND THE RIGHT INTERNAL THORACIC ARTERY FOLLOWED BY GELFOAM EMBOLIZATION WERE PERFORMED. THROUGH SONOGRAPHIC GUIDANCE, THE RIGHT FIFTH INTERCOSTAL ARTERY WAS ENTERED, FOLLOWED BY BLAND AND GELFOAM EMBOLIZATION ON THREE DIFFERENT LARGE TUMOR FEEDER DISTRIBUTIONS. POST-PROCEDURE, THE PATIENT DEVELOPED HEMOPNEUMOTHORAX THAT WAS MANAGED BY SHORT TERM CHEST TUBE. TO DATE, THE PATIENT IS BEING FOLLOWED BY THORACIC ONCOLOGY. CONCLUSION THERE ARE LIMITED THERAPEUTIC OPTIONS FOR UNRESECTABLE PULMONARY HPC. THIS CASE HIGHLIGHTS THE POTENTIAL ROLE OF SERIAL TAE COMBINED WITH AN ANGIOGENESIS INHIBITOR IN LONG TERM CONTROL OF THIS DISEASE. FURTHER TRIALS ARE NEEDED TO EXPLORE WHETHER THIS APPROACH IS EFFECTIVE FOR CONTROL OF LOCAL TUMOR AND DISSEMINATED DISEASE. FOLLOW-UP (11SEP2019): THIS IS A FOLLOW-UP REPORT FROM THE PRODUCT QUALITY COMPLAINTS DEPARTMENT (COMPLAINT NUMBER: (B)(4)). A COMPLAINT HAS BEEN RECEIVED BY PFIZER MANUFACTURING SITE WITH NO REASONABLE SUSPICION OF A MALFUNCTION. HAZARDOUS SITUATION, HAZARD NUMBER (WORST CASE), SEVERITY (WORST CASE), AND P2 VALUE: H10-03 (WORST CASE) WERE ALL UNKNOWN. MDR FOR OTHER CASES INVOLVING LITERATURE STUDIES OF THIS TYPE WERE ISSUED PREVIOUSLY THAT WERE NOT ASSOCIATED WITH THIS CASE. CASE COMMENT: THE UNDERLYING UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA COULD THE LEADING CAUSE OF EVENT HEMOPNEUMOTHORAX. AND THE PROCEDURE ITSELF, OPERATION OF TRANSARTERIAL EMBOLIZATION (TAE), COULD BE THE TRIGGER OF THE ONSET OF THE EVENT. CONSIDERING TEMPORAL RELATIONSHIP, A CONTRIBUTION ROLE OF THE USE OF ABSORBABLE GELATIN (GELFOAM) TO THE EVENT CAN NOT BE ENTIRELY EXCLUDED. ON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION. 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., COMMENT: THE UNDERLYING UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA COULD THE LEADING CAUSE OF EVENT HEMOPNEUMOTHORAX. AND THE PROCEDURE ITSELF, OPERATION OF TRANSARTERIAL EMBOLIZATION (TAE), COULD BE THE TRIGGER OF THE ONSET OF THE EVENT. CONSIDERING TEMPORAL RELATIONSHIP, A CONTRIBUTION ROLE OF THE USE OF ABSORBABLE GELATIN (GELFOAM) TO THE EVENT CAN NOT BE ENTIRELY EXCLUDED. ON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION. 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] POST-PROCEDURE, THE PATIENT DEVELOPED HEMOPNEUMOTHORAX THAT WAS MANAGED BY SHORT TERM CHEST TUBE [TRAUMATIC HAEMOTHORAX] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM RESPIRATORY MEDICINE CASE REPORTS, 2019, VOL 28, ENTITLED "SERIAL TRANSARTERIAL EMBOLIZATION FOR THE MANAGEMENT OF UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA: A CASE REPORT AND REVIEW OF THE LITERATURE." A 37-YEAR-OLD AFRICAN AMERICAN FEMALE PRESENTED TO OUR CANCER CENTER THREE YEARS AGO FOR EVALUATION OF THERAPEUTIC OPTIONS OF UNRESECTABLE PULMONARY HPC. SHE HAS BEEN COMPLAINING OF PROFOUND FATIGUE, RIGHT-SIDED CHEST PAIN, NON-PRODUCTIVE COUGH, UNINTENTIONAL 20 POUND WEIGHT LOSS AND NIGHT SWEATS. HER ONLY PREVIOUS MEDICAL HISTORY WAS AN INCIDENTAL HEART MURMUR DETECTED IN CHILDHOOD. PHYSICAL EXAM WAS UNREMARKABLE WITH THE EXCEPTION OF ABSENT BREATH SOUNDS OVER THE LOWER THIRD OF THE RIGHT HEMITHORAX. DIAGNOSIS WAS PREVIOUSLY MADE WITH CT GUIDED LUNG BIOPSY OF THE THORACIC MASS. HISTOPATHOLOGY REVEALED SPINDLE CELL NEOPLASM WITH OCCASIONAL MITOSES WHICH IS CHARACTERISTIC OF SOLITARY FIBROUS TUMOR/HEMANGIOPERICYTOMA. IMMUNOHISTOCHEMICAL MARKERS WERE STRONGLY POSITIVE FOR CD34, CD99, AND BCL2 AND NEGATIVE FOR KERATIN, CD31, FACTOR VIII, DESMIN, S-100 AND MELANA, CONSISTENT WITH THE DIAGNOSIS OF HEMANGIOPERICYTOMA. CONTRAST ENHANCED CT SCAN OF THE CHEST, ABDOMEN AND PELVIS REVEALED A LARGE 12.4 X 14.0 X 12.5 CM HETEROGENEOUS MASS ON THE ANTERIOR INFERIOR ASPECT OF THE RIGHT HEMITHORAX, NUMEROUS DRAINING VEINS INTO THE LEFT ATRIUM, AND LEFTWARD DEVIATION OF THE MEDIASTINUM CAUSED BY MASS EFFECT. THERE WERE NO SIGNS OF ANY DESTRUCTIVE CHANGES TO THE SURROUNDING RIBS. THE LIVER DEMONSTRATED NUMEROUS ENHANCING LESIONS, THE LARGEST MEASURING 5.6 X 4.6 CM IN THE LEFT HEPATIC LOBE. CT ANGIOGRAPHY SHOWED FEEDER VESSELS FROM THE INFERIOR PHRENIC BRANCH AND INTERCOSTAL VESSELS. ADDITIONAL HYPERVASCULAR MASSES WERE FOUND WITHIN THE LEFT AND RIGHT HEPATIC LOBES. POSITRON EMISSION TOMOGRAPHY (PET) OBTAINED SHOWED NO EVIDENCE OF FLUORODEOXYGLUCOSE (FDG) AVID MALIGNANCY. AFTER MULTIDISCIPLINARY DISCUSSION WITH MEDICAL, RADIATION AND SURGICAL ONCOLOGY, THE TUMOR WAS DEEMED INOPERABLE IN VIEW OF ITS EXTENSIVE VASCULAR BURDEN, RISK OF CATASTROPHIC BLEED AND SPREAD TO THE LIVER. A DECISION TO INITIATE PALLIATIVE CHEMOTHERAPY HAS BEEN DETERMINED. THE PATIENT DID NOT TOLERATE A CHEMOTHERAPY REGIMEN OF TEMOZOLOMIDE AND BEVACIZUMAB DUE TO INTRACTABLE NAUSEA AND VOMITING. TO OFFER LOCAL TUMOUR CONTROL, THE PATIENT UNDERWENT EMBOLIZATION OF THE THORACIC TUMOR FEEDING VESSELS WHICH WERE IDENTIFIED ON ARTERIAL PHASE CT IMAGES AS HYPERTROPHIED ARTERIES. THERE WAS CONCERN FOR NONTARGET EMBOLIZATION WITH EMBOLIZING THESE LARGE BLOOD VESSELS. PRIOR TO EMBOLIZATION, EACH MAJOR TUMOR FEEDING VESSEL IN THE LIVER AND CHEST WAS ASSESSED TO CONFIRM THAT THERE WAS NO LARGE SHUNT. OVERALL, ALTHOUGH THERE WERE MASSIVE DRAINING VEINS, THERE DID NOT SEEM TO BE ANY DIRECT ARTERY TO VEIN SHUNTS THAT WERE NOT AVOIDABLE. INITIAL TAE WAS SUCCESSFULLY PERFORMED ON THE LEFT GASTRIC ARTERY AND RIGHT INFERIOR PHRENIC ARTERY AS WELL AS THE SEGMENT III HEPATIC ARTERY. EMBOLICS USED WERE 40-120, 300-500, 500-700, AND 700-900 MICRON EMBOSPHERES. THESE WERE GIVEN FROM SMALL TO LARGE SEQUENTIALLY UNTIL APPROXIMATELY FIVE HEART BEAT STASIS. ALTHOUGH UNLIKELY THAT THE PULMONARY ARTERY WOULD FEED THIS THORACIC TUMOR ANYWAY, PULMONARY SUPPLY IN FACT WAS CONFIRMED TO NOT BE PRESENT ON CROSS SECTIONAL IMAGING. AS EXPECTED, RECOVERY WAS COMPLICATED BY POSTEMBOLIZATION SYNDROME (PES) THAT REQUIRED HOSPITALIZATION FOR INTRACTABLE NAUSEA AND VOMITING. TWO MONTHS LATER, CT IMAGING OF THE THORAX AND ABDOMEN REVEALED SUCCESSFUL PARTIAL NECROSIS WITH AREAS OF ISCHEMIA WITHIN THE THORACIC MASS ALONG WITH DECREASED SIZE OF THE LIVER LESIONS. HENCE, A SECOND AND THIRD TAE OF THE RIGHT INTERNAL THORACIC ARTERY AND LEFT GASTRIC ARTERY WERE SUBSEQUENTLY PERFORMED FIVE MONTHS APART FOR FURTHER LOCAL TUMOUR CONTROL AND TUMOR NECROSIS. SIX MONTHS FOLLOWING THE LAST TAE, CT SHOWED NEAR COMPLETE REMISSION OF LIVER LESIONS, AND ONLY MINIMAL INCREASE IN THE SIZE OF THE RIGHT THORACIC MASS CRANIOCAUDALLY, MEASURING 19.5 CM AS COMPARED TO PREVIOUSLY 17.7 CM. INCREASED SIZE WAS ATTRIBUTED TO INCREASED NECROTIC FLUID WITHIN THE MASS. THERE WAS A SIMILAR DEGREE OF DRAINING AND SUPPLYING TUMOR VESSLES WITHIN THE ANTERIOR MEDIASTINUM. ALTHOUGH TAE DID NOT LEAD TO COMPLETE REMISSION OF THE TUMOR, HOWEVER, IT PROVIDED LONG TERM CONTROL. CONSEQUENTLY, DECISION HAS BEEN MADE TO INITIATE AN ORAL ANGIOGENESIS INHIBITOR SUNITINIB. PATIENT ELECTED FOR A ONE-YEAR SURVEILLANCE INTERVAL. SUBSEQUENTLY, PET SCAN WAS PERFORMED TO MONITOR DISEASE PROGRESSION. THE THORACIC MASS SHOWED A CURVILINEAR FOCUS OF MILDLY INCREASED FDG UPTAKE ALONG THE SUPERIOR LATERAL ASPECT WITH NO REAL SIGNIFICANT CHANGE OF SIZE. FDG AVID, LOW ATTENUATION OF THE LEFT HEPATIC LOBE LESIONS WERE DEMONSTRATED. CLINICALLY, THE PATIENT WAS THOUGHT TO HAVE DISEASE PROGRESSION AND UNDERWENT THE FOURTH TAE. DURING THE PROCEDURE, SUCCESSFUL BLAND EMBOLIZATION TO SEGMENTS IVA AND IVB LEFT HEPATIC ARTERY BRANCHES, THE RIGHT HEPATIC ARTERY, A BRANCH OF THE INFERIOR PHRENIC ARTERY, THE INFERIOR EPIGASTRIC ARTERY AND THE RIGHT INTERNAL THORACIC ARTERY FOLLOWED BY GELFOAM EMBOLIZATION WERE PERFORMED. THROUGH SONOGRAPHIC GUIDANCE, THE RIGHT FIFTH INTERCOSTAL ARTERY WAS ENTERED, FOLLOWED BY BLAND AND GELFOAM EMBOLIZATION ON THREE DIFFERENT LARGE TUMOR FEEDER DISTRIBUTIONS. POST-PROCEDURE, THE PATIENT DEVELOPED HEMOPNEUMOTHORAX THAT WAS MANAGED BY SHORT TERM CHEST TUBE. TO DATE, THE PATIENT IS BEING FOLLOWED BY THORACIC ONCOLOGY. CONCLUSION THERE ARE LIMITED THERAPEUTIC OPTIONS FOR UNRESECTABLE PULMONARY HPC. THIS CASE HIGHLIGHTS THE POTENTIAL ROLE OF SERIAL TAE COMBINED WITH AN ANGIOGENESIS INHIBITOR IN LONG TERM CONTROL OF THIS DISEASE. FURTHER TRIALS ARE NEEDED TO EXPLORE WHETHER THIS APPROACH IS EFFECTIVE FOR CONTROL OF LOCAL TUMOR AND DISSEMINATED DISEASE. FOLLOW-UP (11SEP2019): THIS IS A FOLLOW-UP REPORT FROM THE PRODUCT QUALITY COMPLAINTS DEPARTMENT (COMPLAINT NUMBER: (B)(4)). A COMPLAINT HAS BEEN RECEIVED BY PFIZER MANUFACTURING SITE WITH NO REASONABLE SUSPICION OF A MALFUNCTION. HAZARDOUS SITUATION, HAZARD NUMBER (WORST CASE), SEVERITY (WORST CASE), AND P2 VALUE: H10-03 (WORST CASE) WERE ALL UNKNOWN. MDR FOR OTHER CASES INVOLVING LITERATURE STUDIES OF THIS TYPE WERE ISSUED PREVIOUSLY THAT WERE NOT ASSOCIATED WITH THIS CASE. FOLLOW-UP (28SEP2019): ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: THE HEMOPNEUMOTHORAX WAS NOT THOUGHT TO BE SECONDARY TO THE GELFOAM. "I CHECKED WITH MY CO-AUTHORS." FOLLOW-UP (02OCT2019 ): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4)), FOR ABSORBABLE GELATIN (GELFOAM). SEVERITY OF HARM: S3. THE PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 100 X 6; LOT-#: UNKNOWN. REFERENCE ID NUMBERS: PR ID: (B)(4), PR ID: (B)(4), PARENT ID: (B)(4). (PARENT) UDI-(IF APPL): (B)(4). QA REVIEW & RATIONALE: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. INVESTIGATIONS FINDINGS: SUMMARY OF INVESTIGATION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT SUSTAINED A HEMOPNEUMOTHORAX (BLOOD AND AIR IN CHEST CAVITY) AS A COMPLICATION DURING A SURGICAL PROCEDURE. GELFOAM WAS USED TO STOP BLEEDING DURING THE EVENT THEREFORE MAKING IT A SUSPECT PRODUCT BY TEMPORAL RELATION. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. NO LOT-SPECIFIC TREND IDENTIFIED. PARENT SAMPLE STATUS NOT AVAILABLE. CASE COMMENT: THE UNDERLYING UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA COULD THE LEADING CAUSE OF EVENT HEMOPNEUMOTHORAX. AND THE PROCEDURE ITSELF, OPERATION OF TRANSARTERIAL EMBOLIZATION (TAE), COULD BE THE TRIGGER OF THE ONSET OF THE EVENT. CONSIDERING TEMPORAL RELATIONSHIP, A CONTRIBUTION ROLE OF THE USE OF ABSORBABLE GELATIN (GELFOAM) TO THE EVENT CAN NOT BE ENTIRELY EXCLUDED. ON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION. 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., COMMENT: THE UNDERLYING UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA COULD THE LEADING CAUSE OF EVENT HEMOPNEUMOTHORAX. AND THE PROCEDURE ITSELF, OPERATION OF TRANSARTERIAL EMBOLIZATION (TAE), COULD BE THE TRIGGER OF THE ONSET OF THE EVENT. CONSIDERING TEMPORAL RELATIONSHIP, A CONTRIBUTION ROLE OF THE USE OF ABSORBABLE GELATIN (GELFOAM) TO THE EVENT CAN NOT BE ENTIRELY EXCLUDED. ON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION. 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] POST-PROCEDURE, THE PATIENT DEVELOPED HEMOPNEUMOTHORAX THAT WAS MANAGED BY SHORT TERM CHEST TUBE [TRAUMATIC HAEMOTHORAX]. CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE RESPIRATORY MEDICINE CASE REPORTS, 2019, VOL 28 ENTITLED SERIAL TRANSARTERIAL EMBOLIZATION FOR THE MANAGEMENT OF UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA: A CASE REPORT AND REVIEW OF THE LITERATURE. THIS CASE BELONGS TO A (B)(6) FEMALE WHO EXPERIENCED AS HEMOPNEUMOTHORAX WITH SUSPECT DRUG GELFOAM. A (B)(6) AFRICAN AMERICAN FEMALE PRESENTED TO OUR CANCER CENTER THREE YEARS AGO FOR EVALUATION OF THERAPEUTIC OPTIONS OF UNRESECTABLE PULMONARY HPC. SHE HAS BEEN COMPLAINING OF PROFOUND FATIGUE, RIGHT-SIDED CHEST PAIN, NON-PRODUCTIVE COUGH, UNINTENTIONAL 20 POUND WEIGHT LOSS AND NIGHT SWEATS. HER ONLY PREVIOUS MEDICAL HISTORY WAS AN INCIDENTAL HEART MURMUR DETECTED IN CHILDHOOD. PHYSICAL EXAM WAS UNREMARKABLE WITH THE EXCEPTION OF ABSENT BREATH SOUNDS OVER THE LOWER THIRD OF THE RIGHT HEMITHORAX. DIAGNOSIS WAS PREVIOUSLY MADE WITH CT GUIDED LUNG BIOPSY OF THE THORACIC MASS. HISTOPATHOLOGY REVEALED SPINDLE CELL NEOPLASM WITH OCCASIONAL MITOSES WHICH IS CHARACTERISTIC OF SOLITARY FIBROUS TUMOR/HEMANGIOPERICYTOMA. IMMUNOHISTOCHEMICAL MARKERS WERE STRONGLY POSITIVE FOR CD34, CD99, AND BCL2 AND NEGATIVE FOR KERATIN, CD31, FACTOR VIII, DESMIN, S-100 AND MELANA, CONSISTENT WITH THE DIAGNOSIS OF HEMANGIOPERICYTOMA. CONTRAST ENHANCED CT SCAN OF THE CHEST, ABDOMEN AND PELVIS REVEALED A LARGE 12.4 X 14.0 X 12.5 CM HETEROGENEOUS MASS ON THE ANTERIOR INFERIOR ASPECT OF THE RIGHT HEMITHORAX, NUMEROUS DRAINING VEINS INTO THE LEFT ATRIUM, AND LEFTWARD DEVIATION OF THE MEDIASTINUM CAUSED BY MASS EFFECT. THERE WERE NO SIGNS OF ANY DESTRUCTIVE CHANGES TO THE SURROUNDING RIBS. THE LIVER DEMONSTRATED NUMEROUS ENHANCING LESIONS, THE LARGEST MEASURING 5.6 X 4.6 CM IN THE LEFT HEPATIC LOBE. CT ANGIOGRAPHY SHOWED FEEDER VESSELS FROM THE INFERIOR PHRENIC BRANCH AND INTERCOSTAL VESSELS. ADDITIONAL HYPERVASCULAR MASSES WERE FOUND WITHIN THE LEFT AND RIGHT HEPATIC LOBES. POSITRON EMISSION TOMOGRAPHY (PET) OBTAINED SHOWED NO EVIDENCE OF FLUORODEOXYGLUCOSE (FDG) AVID MALIGNANCY. AFTER MULTIDISCIPLINARY DISCUSSION WITH MEDICAL, RADIATION AND SURGICAL ONCOLOGY, THE TUMOR WAS DEEMED INOPERABLE IN VIEW OF ITS EXTENSIVE VASCULAR BURDEN, RISK OF CATASTROPHIC BLEED AND SPREAD TO THE LIVER. A DECISION TO INITIATE PALLIATIVE CHEMOTHERAPY HAS BEEN DETERMINED. THE PATIENT DID NOT TOLERATE A CHEMOTHERAPY REGIMEN OF TEMOZOLOMIDE AND BEVACIZUMAB DUE TO INTRACTABLE NAUSEA AND VOMITING TO OFFER LOCAL TUMOUR CONTROL, THE PATIENT UNDERWENT EMBOLIZATION OF THE THORACIC TUMOR FEEDING VESSELS WHICH WERE IDENTIFIED ON ARTERIAL PHASE CT IMAGES AS HYPERTROPHIED ARTERIES. THERE WAS CONCERN FOR NONTARGET EMBOLIZATION WITH EMBOLIZING THESE LARGE BLOOD VESSELS. PRIOR TO EMBOLIZATION, EACH MAJOR TUMOR FEEDING VESSEL IN THE LIVER AND CHEST WAS ASSESSED TO CONFIRM THAT THERE WAS NO LARGE SHUNT. OVERALL, ALTHOUGH THERE WERE MASSIVE DRAINING VEINS, THERE DID NOT SEEM TO BE ANY DIRECT ARTERY TO VEIN SHUNTS THAT WERE NOT AVOIDABLE. INITIAL TAE WAS SUCCESSFULLY PERFORMED ON THE LEFT GASTRIC ARTERY AND RIGHT INFERIOR PHRENIC ARTERY AS WELL AS THE SEGMENT III HEPATIC ARTERY. EMBOLICS USED WERE 40-120, 300-500, 500-700, AND 700-900 MICRON EMBOSPHERES. THESE WERE GIVEN FROM SMALL TO LARGE SEQUENTIALLY UNTIL APPROXIMATELY FIVE HEART BEAT STASIS. ALTHOUGH UNLIKELY THAT THE PULMONARY ARTERY WOULD FEED THIS THORACIC TUMOR ANYWAY, PULMONARY SUPPLY IN FACT WAS CONFIRMED TO NOT BE PRESENT ON CROSS SECTIONAL IMAGING. AS EXPECTED, RECOVERY WAS COMPLICATED BY POSTEMBOLIZATION SYNDROME (PES) THAT REQUIRED HOSPITALIZATION FOR INTRACTABLE NAUSEA AND VOMITING. TWO MONTHS LATER, CT IMAGING OF THE THORAX AND ABDOMEN REVEALED SUCCESSFUL PARTIAL NECROSIS WITH AREAS OF ISCHEMIA WITHIN THE THORACIC MASS ALONG WITH DECREASED SIZE OF THE LIVER LESIONS. HENCE, A SECOND AND THIRD TAE OF THE RIGHT INTERNAL THORACIC ARTERY AND LEFT GASTRIC ARTERY WERE SUBSEQUENTLY PERFORMED FIVE MONTHS APART FOR FURTHER LOCAL TUMOUR CONTROL AND TUMOR NECROSIS. SIX MONTHS FOLLOWING THE LAST TAE, CT SHOWED NEAR COMPLETE REMISSION OF LIVER LESIONS, AND ONLY MINIMAL INCREASE IN THE SIZE OF THE RIGHT THORACIC MASS CRANIOCAUDALLY, MEASURING 19.5 CM AS COMPARED TO PREVIOUSLY 17.7 CM. INCREASED SIZE WAS ATTRIBUTED TO INCREASED NECROTIC FLUID WITHIN THE MASS. THERE WAS A SIMILAR DEGREE OF DRAINING AND SUPPLYING TUMOR VESSELS WITHIN THE ANTERIOR MEDIASTINUM. ALTHOUGH TAE DID NOT LEAD TO COMPLETE REMISSION OF THE TUMOR, HOWEVER, IT PROVIDED LONG TERM CONTROL. CONSEQUENTLY, DECISION HAS BEEN MADE TO INITIATE AN ORAL ANGIOGENESIS INHIBITOR SUNITINIB. PATIENT ELECTED FOR A ONE-YEAR SURVEILLANCE INTERVAL. SUBSEQUENTLY, PET SCAN WAS PERFORMED TO MONITOR DISEASE PROGRESSION. THE THORACIC MASS SHOWED A CURVILINEAR FOCUS OF MILDLY INCREASED FDG UPTAKE ALONG THE SUPERIOR LATERAL ASPECT WITH NO REAL SIGNIFICANT CHANGE OF SIZE. FDG AVID, LOW ATTENUATION OF THE LEFT HEPATIC LOBE LESIONS WERE DEMONSTRATED. CLINICALLY, THE PATIENT WAS THOUGHT TO HAVE DISEASE PROGRESSION AND UNDERWENT THE FOURTH TAE. DURING THE PROCEDURE, SUCCESSFUL BLAND EMBOLIZATION TO SEGMENTS IVA AND IVB LEFT HEPATIC ARTERY BRANCHES, THE RIGHT HEPATIC ARTERY, A BRANCH OF THE INFERIOR PHRENIC ARTERY, THE INFERIOR EPIGASTRIC ARTERY AND THE RIGHT INTERNAL THORACIC ARTERY FOLLOWED BY GELFOAM EMBOLIZATION WERE PERFORMED. THROUGH SONOGRAPHIC GUIDANCE, THE RIGHT FIFTH INTERCOSTAL ARTERY WAS ENTERED, FOLLOWED BY BLAND AND GELFOAM EMBOLIZATION ON THREE DIFFERENT LARGE TUMOR FEEDER DISTRIBUTIONS. POST-PROCEDURE, THE PATIENT DEVELOPED HEMOPNEUMOTHORAX THAT WAS MANAGED BY SHORT TERM CHEST TUBE. TO DATE, THE PATIENT IS BEING FOLLOWED BY THORACIC ONCOLOGY. CONCLUSION THERE ARE LIMITED THERAPEUTIC OPTIONS FOR UNRESECTABLE PULMONARY HPC. THIS CASE HIGHLIGHTS THE POTENTIAL ROLE OF SERIAL TAE COMBINED WITH AN ANGIOGENESIS INHIBITOR IN LONG TERM CONTROL OF THIS DISEASE. FURTHER TRIALS ARE NEEDED TO EXPLORE WHETHER THIS APPROACH IS EFFECTIVE FOR CONTROL OF LOCAL TUMOR AND DISSEMINATED DISEASE., COMMENT: THE UNDERLYING UNRESECTABLE MALIGNANT PULMONARY HEMANGIOPERICYTOMA COULD THE LEADING CAUSE OF EVENT HEMOPNEUMOTHORAX. AND THE PROCEDURE ITSELF, OPERATION OF TRANSARTERIAL EMBOLIZATION (TAE), COULD BE THE TRIGGER OF THE ONSET OF THE EVENT. CONSIDERING TEMPORAL RELATIONSHIP, A CONTRIBUTION ROLE OF THE USE OF ABSORBABLE GELATIN (GELFOAM) TO THE EVENT CAN NOT BE ENTIRELY EXCLUDED. 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 |
|---|---|---|---|---|---|---|---|
| 878887 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Required Intervention| O | BEVACIZUMAB| BEVACIZUMAB| BEVACIZUMAB| BEVACIZUMAB| BEVACIZUMAB| SUNITINIB| SUNITINIB| SUNITINIB| TEMOZOLOMIDE| TEMOZOLOMIDE| TEMOZOLOMIDE| TEMOZOLOMIDE| TEMOZOLOMIDE |