GELFOAM
Report
- Report Number
- 1810189-2019-00038
- Event Type
- Injury
- Date Received
- June 3, 2019
- Report Date
- May 21, 2019
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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 IS NOT REQUIRED.
[1810189-20190603224043_LIT.PDF].
ON 23OCT2019 FROM PQC SITE: SEVERITY OF HARM WAS S5. SAMPLES, PHOTOS WERE NOT AVAILABLE, SITE HAS NOT RECEIVED SAMPLE. PACKAGING RECORDS: COMPLETE -ACCEPTABLE. 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. PER REVIEW OF THE APRR REPORTS OVER THE EXPIRY INTERVAL REACHING BACK FROM THE RECEIPT OF THE COMPLIANT, THERE WERE NO BATCHES PRODUCED WITH ANALYTICAL TESTING RESULTS THAT WERE OUTSIDE OF REGISTERED SPECIFICATIONS PRIOR TO RELEASE. RSRV. SAMPLE EVALUATION WAS NOT REQUIRED AS THE BATCH NUMBER IS UNKNOWN. REFERENCE SAMPLE EXAMINATION: COMPLETE -ACCEPTABLE. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT DEVELOPED PERIGRAFT AIR LEADING TO AN INFECTION/ABSCESS IN THE AREA OF PRODUCT USE. ALTHOUGH AIR TRAPPED BETWEEN TISSUES IMMEDIATELY AFTER A PROCEDURE IS A COMMON FINDING, INCREASE IN INFLAMMATORY MARKERS AND SYMPTOMS DURING THE LATER PHASE POST OPERATIVE, IS SUGGESTIVE OF AN INFECTION. THE OUTCOME OF THE EVENT IS UNKNOWN. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. THE FIELD FOR DEVICE MALFUNCTION IN CITI IS REQUIRED TO CONDITIONALLY POPULATE THE SEVERITY RANKING. ON 13JUL2019, 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 IS NOT REQUIRED.
EVENT VERBATIM [PREFERRED TERM] STERILE MEDIASTINAL GAS [PNEUMOMEDIASTINUM] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE RADIOLOGY CASE REPORTS, 2018, VOL 13(2); PP 343-346, ENTITLED PERIGRAFT AIR MIMICKING INFECTION ON CT ANGIOGRAPHY FOLLOWING OPEN ABDOMINAL AORTIC ANEURYSM REPAIR, WHICH REFERENCED AN UNKNOWN PATIENT TAKING GELFOAM AND EXPERIENCED STERILE MEDIASTINAL GAS WAS IDENTIFIED IN THE REFERENCE SECTION. THE ARTICLE THAT FULLY DISCUSSES THIS PATIENT IS FOUND IN THE CHEST, 1992, VOL 102(6); PP 1911-13, ENTITLED STERILE MEDIASTINAL GAS MIMICKING ABSCESS IN AORTIC ANEURYSM REPAIR. THE FULL PUBLICATION OF THE REFERENCE ARTICLE HAS BEEN REQUESTED. A CASE REPORT DID LOOK AT THE POSSIBLE ROLE OF GELFOAM IN A PATIENT WHO PRESENTED 6 WEEKS POSTOPERATIVELY AFTER AN OPEN ASCENDING AORTIC ANEURYSM REPAIR WITH A 1-WEEK HISTORY OF NIGHT SWEATS, FEVER, AND CHILLS, WHOM THEY SUSPECTED OF HAVING AN ABSCESS AT THE SITE OF REPAIR. AFTER AN EXTENSIVE WORKUP, INCLUDING A NEGATIVE WBC SCAN AND NEGATIVE EXPLORATORY LAPAROTOMY, THEY CONCLUDED THAT THE REGION OF EXTENSIVE ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE CORRESPONDED TO THE SITE OF THE GAS COLLECTION DEMONSTRATED, AND LIKELY THE CAUSATION OF POSTOPERATIVE AIR. FOLLOW-UP (31MAY2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4)). SEVERITY LEVEL, HAZARDOUS SITUATION AND P2 VALUE. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH REASONABLE OF A MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY OF S5, AND THEREFORE REQUIRES ESCALATION TO PFIZER US SAFETY. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. THE COMPLAINT VERBATIM IS AS FOLLOWS: "AORTIC GRAFT INFECTION IS A FEARED COMPLICATION AFTER OPEN ABDOMINAL AORTIC ANEURYSM REPAIR SECONDARY TO ITS HIGH MORTALITY. PERIGRAFT AIR IS A COMMON FINDING AFTER OPEN AORTIC ANEURYSM REPAIR; HOWEVER, IT IS ALSO ASSOCIATED WITH AORTIC GRAFT INFECTION. DELINEATING BETWEEN GRAFT INFECTION AND COMMON POSTOPERATIVE FINDING IS A CHALLENGE. THIS IS FURTHER COMPLICATED BY USE OF HEMOSTATIC AGENTS SUCH AS GELFOAM, WHICH IS ALSO DOCUMENTED TO CAUSE PERIGRAFT AIR. CORRECT DIAGNOSIS HAS CRUCIAL IMPLICATIONS IN MANAGEMENT OF POTENTIAL AORTIC GRAFT INFECTION, WHICH IS A VASCULAR EMERGENCY. WE REPORT A CASE OF PERIGRAFT AIR IN A PATIENT STATUS AFTER OPEN AORTIC ANEURYSM REPAIR WITH ASSOCIATED CLINICAL MANIFESTATIONS OF INFECTION IN WHOM CONSERVATIVE MANAGEMENT AND SURVEILLANCE WAS SELECTED FOR TREATMENT. WE THEN DISCUSS THE TIMELINE OF PERIGRAFT AIR, POTENTIAL CAUSATION, IMPORTANCE OF HISTORY, AND PHYSICAL EXAMINATION, AND FINALLY, WE DISCUSS HOW SPECIFIC FINDINGS ON COMPUTED TOMOGRAPHY IMAGING FOR INFECTION IN OTHER AREAS MAY BE USEFUL IN AORTIC GRAFT INFECTION." HAZARDOUS SITUATION (WORST CASE SEVERITY S5): PATHOGEN CONTAMINATION (BACTERIAL, VIRAL, FUNGAL, PROTISTIC, OR OTHER HIGHLY RESISTANT PATHOGENS). HAZARD NUMBER: H02-01. P2 VALUE FOR A SEVERITY OF S3: 0.789; P2 VALUE FOR A SEVERITY OF S4: 0.21; P2 VALUE FOR A SEVERITY OF S5: 0. FOLLOW-UP (13JUL2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS GROUP. 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. PGS DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. AN EXPANDED TIME PERIOD WAS USED FOR THE ANALYSIS OF TRENDING TO CAPTURE COMPLAINTS THAT HAVE BEEN RECEIVED BY PFIZER KALAMAZOO AS A RESULT OF A REMEDIATION EFFORT BY PFIZER US SAFETY, THEIR FULL RANGE OF COMPLAINT CONTACT DATES, AND THE ASSOCIATED PRODUCT EXPIRY WINDOWS. 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, THIS IS DUE TO THE REMEDIATION EFFORT NOTED ABOVE. 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 REMEDIATION BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATIONS ROOT CAUSE: PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. A REVIEW OF THE APRR REPORTS, DEVIATIONS, AND AN EVALUATION OF TRENDS INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. IMPACT ANALYSIS: BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDED THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. 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 IS NOT REQUIRED. FOLLOW-UP (12JUL2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4)), FOR ABSORBABLE GELATIN (GELFOAM). PR ID WAS 3941357 REPORTING REASONABLY SUGGEST DEVICE MALFUNCTION WAS YES, SEVERITY OF HARM WAS S5, COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION, COMPLAINT SUB-CLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE EXCLUDED. PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. NO CORRECTIVE ACTION OR FURTHER ACTION REQUIRED PER INVESTIGATION RESULT. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PRODUCT PROBLEM CHECKED ON THE MEDWATCH INFORMATION PAGE., COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE EXCLUDED. PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. NO CORRECTIVE ACTION OR FURTHER ACTION REQUIRED PER INVESTIGATION RESULT.
STERILE MEDIASTINAL GAS [PNEUMOMEDIASTINUM]. CASE DESCRIPTION: THIS IS A LITERATURE REPORT FROM THE RADIOLOGY CASE REPORTS, 2018, VOL 13(2); PP 343-346, ENTITLED PERIGRAFT AIR MIMICKING INFECTION ON CT ANGIOGRAPHY FOLLOWING OPEN ABDOMINAL AORTIC ANEURYSM REPAIR, WHICH REFERENCED AN UNKNOWN PATIENT TAKING GELFOAM AND EXPERIENCED STERILE MEDIASTINAL GAS WAS IDENTIFIED IN THE REFERENCE SECTION. THE ARTICLE THAT FULLY DISCUSSES THIS PATIENT IS FOUND IN THE CHEST, 1992, VOL 102(6); PP 1911-13, ENTITLED STERILE MEDIASTINAL GAS MIMICKING ABSCESS IN AORTIC ANEURYSM REPAIR. THE FULL PUBLICATION OF THE REFERENCE ARTICLE HAS BEEN REQUESTED. A CASE REPORT DID LOOK AT THE POSSIBLE ROLE OF GELFOAM IN A PATIENT WHO PRESENTED 6 WEEKS POSTOPERATIVELY AFTER AN OPEN ASCENDING AORTIC ANEURYSM REPAIR WITH A 1-WEEK HISTORY OF NIGHT SWEATS, FEVER, AND CHILLS, WHOM THEY SUSPECTED OF HAVING AN ABSCESS AT THE SITE OF REPAIR. AFTER AN EXTENSIVE WORKUP, INCLUDING A NEGATIVE WBC SCAN AND NEGATIVE EXPLORATORY LAPAROTOMY, THEY CONCLUDED THAT THE REGION OF EXTENSIVE ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE CORRESPONDED TO THE SITE OF THE GAS COLLECTION DEMONSTRATED, AND LIKELY THE CAUSATION OF POSTOPERATIVE AIR. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE EXCLUDED. THIS CASE WILL BE REASSESSED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM] STERILE MEDIASTINAL GAS [PNEUMOMEDIASTINUM] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE RADIOLOGY CASE REPORTS, 2018, VOL 13(2); PP 343-346, ENTITLED PERIGRAFT AIR MIMICKING INFECTION ON CT ANGIOGRAPHY FOLLOWING OPEN ABDOMINAL AORTIC ANEURYSM REPAIR, WHICH REFERENCED AN UNKNOWN PATIENT TAKING GELFOAM AND EXPERIENCED STERILE MEDIASTINAL GAS WAS IDENTIFIED IN THE REFERENCE SECTION. THE ARTICLE THAT FULLY DISCUSSES THIS PATIENT IS FOUND IN THE CHEST, 1992, VOL 102(6); PP 1911-13, ENTITLED STERILE MEDIASTINAL GAS MIMICKING ABSCESS IN AORTIC ANEURYSM REPAIR. THE FULL PUBLICATION OF THE REFERENCE ARTICLE HAS BEEN REQUESTED. A CASE REPORT DID LOOK AT THE POSSIBLE ROLE OF GELFOAM IN A PATIENT WHO PRESENTED 6 WEEKS POSTOPERATIVELY AFTER AN OPEN ASCENDING AORTIC ANEURYSM REPAIR WITH A 1-WEEK HISTORY OF NIGHT SWEATS, FEVER, AND CHILLS, WHOM THEY SUSPECTED OF HAVING AN ABSCESS AT THE SITE OF REPAIR. AFTER AN EXTENSIVE WORKUP, INCLUDING A NEGATIVE WBC SCAN AND NEGATIVE EXPLORATORY LAPAROTOMY, THEY CONCLUDED THAT THE REGION OF EXTENSIVE ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE CORRESPONDED TO THE SITE OF THE GAS COLLECTION DEMONSTRATED, AND LIKELY THE CAUSATION OF POSTOPERATIVE AIR. FOLLOW-UP (31MAY2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4). SEVERITY LEVEL, HAZARDOUS SITUATION AND P2 VALUE. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH REASONABLE OF A MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY OF S5, AND THEREFORE REQUIRES ESCALATION TO PFIZER US SAFETY. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. THE COMPLAINT VERBATIM IS AS FOLLOWS: "AORTIC GRAFT INFECTION IS A FEARED COMPLICATION AFTER OPEN ABDOMINAL AORTIC ANEURYSM REPAIR SECONDARY TO ITS HIGH MORTALITY. PERIGRAFT AIR IS A COMMON FINDING AFTER OPEN AORTIC ANEURYSM REPAIR; HOWEVER, IT IS ALSO ASSOCIATED WITH AORTIC GRAFT INFECTION. DELINEATING BETWEEN GRAFT INFECTION AND COMMON POSTOPERATIVE FINDING IS A CHALLENGE. THIS IS FURTHER COMPLICATED BY USE OF HEMOSTATIC AGENTS SUCH AS GELFOAM, WHICH IS ALSO DOCUMENTED TO CAUSE PERIGRAFT AIR. CORRECT DIAGNOSIS HAS CRUCIAL IMPLICATIONS IN MANAGEMENT OF POTENTIAL AORTIC GRAFT INFECTION, WHICH IS A VASCULAR EMERGENCY. WE REPORT A CASE OF PERIGRAFT AIR IN A PATIENT STATUS AFTER OPEN AORTIC ANEURYSM REPAIR WITH ASSOCIATED CLINICAL MANIFESTATIONS OF INFECTION IN WHOM CONSERVATIVE MANAGEMENT AND SURVEILLANCE WAS SELECTED FOR TREATMENT. WE THEN DISCUSS THE TIMELINE OF PERIGRAFT AIR, POTENTIAL CAUSATION, IMPORTANCE OF HISTORY, AND PHYSICAL EXAMINATION, AND FINALLY, WE DISCUSS HOW SPECIFIC FINDINGS ON COMPUTED TOMOGRAPHY IMAGING FOR INFECTION IN OTHER AREAS MAY BE USEFUL IN AORTIC GRAFT INFECTION." HAZARDOUS SITUATION (WORST CASE SEVERITY S5): PATHOGEN CONTAMINATION (BACTERIAL, VIRAL, FUNGAL, PROTISTIC, OR OTHER HIGHLY RESISTANT PATHOGENS). HAZARD NUMBER: H02-01. P2 VALUE FOR A SEVERITY OF S3: 0.789; P2 VALUE FOR A SEVERITY OF S4: 0.21; P2 VALUE FOR A SEVERITY OF S5: 0. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE 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., COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE 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.
STERILE MEDIASTINAL GAS [PNEUMOMEDIASTINUM]. CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE RADIOLOGY CASE REPORTS, 2018, VOL 13(2); PP 343-346, ENTITLED PERIGRAFT AIR MIMICKING INFECTION ON CT ANGIOGRAPHY FOLLOWING OPEN ABDOMINAL AORTIC ANEURYSM REPAIR, WHICH REFERENCED AN UNKNOWN PATIENT TAKING GELFOAM AND EXPERIENCED STERILE MEDIASTINAL GAS WAS IDENTIFIED IN THE REFERENCE SECTION. THE ARTICLE THAT FULLY DISCUSSES THIS PATIENT IS FOUND IN THE CHEST, 1992, VOL 102(6); PP 1911-13, ENTITLED STERILE MEDIASTINAL GAS MIMICKING ABSCESS IN AORTIC ANEURYSM REPAIR. THE FULL PUBLICATION OF THE REFERENCE ARTICLE HAS BEEN REQUESTED. A CASE REPORT DID LOOK AT THE POSSIBLE ROLE OF GELFOAM IN A PATIENT WHO PRESENTED 6 WEEKS POSTOPERATIVELY AFTER AN OPEN ASCENDING AORTIC ANEURYSM REPAIR WITH A 1-WEEK HISTORY OF NIGHT SWEATS, FEVER, AND CHILLS, WHOM THEY SUSPECTED OF HAVING AN ABSCESS AT THE SITE OF REPAIR. AFTER AN EXTENSIVE WORKUP, INCLUDING A NEGATIVE WBC SCAN AND NEGATIVE EXPLORATORY LAPAROTOMY, THEY CONCLUDED THAT THE REGION OF EXTENSIVE ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE CORRESPONDED TO THE SITE OF THE GAS COLLECTION DEMONSTRATED, AND LIKELY THE CAUSATION OF POSTOPERATIVE AIR. FOLLOW-UP (31MAY2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4)). SEVERITY LEVEL, HAZARDOUS SITUATION AND P2 VALUE. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH REASONABLE OF A MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY OF S5, AND THEREFORE REQUIRES ESCALATION TO PFIZER US SAFETY. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. THE COMPLAINT VERBATIM IS AS FOLLOWS: "AORTIC GRAFT INFECTION IS A FEARED COMPLICATION AFTER OPEN ABDOMINAL AORTIC ANEURYSM REPAIR SECONDARY TO ITS HIGH MORTALITY. PERIGRAFT AIR IS A COMMON FINDING AFTER OPEN AORTIC ANEURYSM REPAIR; HOWEVER, IT IS ALSO ASSOCIATED WITH AORTIC GRAFT INFECTION. DELINEATING BETWEEN GRAFT INFECTION AND COMMON POSTOPERATIVE FINDING IS A CHALLENGE. THIS IS FURTHER COMPLICATED BY USE OF HEMOSTATIC AGENTS SUCH AS GELFOAM, WHICH IS ALSO DOCUMENTED TO CAUSE PERIGRAFT AIR. CORRECT DIAGNOSIS HAS CRUCIAL IMPLICATIONS IN MANAGEMENT OF POTENTIAL AORTIC GRAFT INFECTION, WHICH IS A VASCULAR EMERGENCY. WE REPORT A CASE OF PERIGRAFT AIR IN A PATIENT STATUS AFTER OPEN AORTIC ANEURYSM REPAIR WITH ASSOCIATED CLINICAL MANIFESTATIONS OF INFECTION IN WHOM CONSERVATIVE MANAGEMENT AND SURVEILLANCE WAS SELECTED FOR TREATMENT. WE THEN DISCUSS THE TIMELINE OF PERIGRAFT AIR, POTENTIAL CAUSATION, IMPORTANCE OF HISTORY, AND PHYSICAL EXAMINATION, AND FINALLY, WE DISCUSS HOW SPECIFIC FINDINGS ON COMPUTED TOMOGRAPHY IMAGING FOR INFECTION IN OTHER AREAS MAY BE USEFUL IN AORTIC GRAFT INFECTION." HAZARDOUS SITUATION (WORST CASE SEVERITY S5): PATHOGEN CONTAMINATION (BACTERIAL, VIRAL, FUNGAL, PROTISTIC, OR OTHER HIGHLY RESISTANT PATHOGENS). HAZARD NUMBER: H02-01. P2 VALUE FOR A SEVERITY OF S3: 0.789; P2 VALUE FOR A SEVERITY OF S4: 0.21; P2 VALUE FOR A SEVERITY OF S5: 0. FOLLOW-UP (13JUL2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS GROUP. 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. PGS DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. AN EXPANDED TIME PERIOD WAS USED FOR THE ANALYSIS OF TRENDING TO CAPTURE COMPLAINTS THAT HAVE BEEN RECEIVED BY PFIZER KALAMAZOO AS A RESULT OF A REMEDIATION EFFORT BY PFIZER US SAFETY, THEIR FULL RANGE OF COMPLAINT CONTACT DATES, AND THE ASSOCIATED PRODUCT EXPIRY WINDOWS. 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, THIS IS DUE TO THE REMEDIATION EFFORT NOTED ABOVE. 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 REMEDIATION BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATIONS ROOT CAUSE: PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. A REVIEW OF THE APRR REPORTS, DEVIATIONS, AND AN EVALUATION OF TRENDS INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. IMPACT ANALYSIS: BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDED THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. 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 IS NOT REQUIRED. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE EXCLUDED. PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. NO CORRECTIVE ACTION OR FURTHER ACTION REQUIRED PER INVESTIGATION RESULT., COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE EXCLUDED. PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. NO CORRECTIVE ACTION OR FURTHER ACTION REQUIRED PER INVESTIGATION RESULT.
EVENT VERBATIM [PREFERRED TERM] STERILE MEDIASTINAL GAS [PNEUMOMEDIASTINUM] , . CASE NARRATIVE:THIS IS A LITERATURE REPORT FROM THE RADIOLOGY CASE REPORTS, 2018, VOL 13(2); PP 343-346, ENTITLED PERIGRAFT AIR MIMICKING INFECTION ON CT ANGIOGRAPHY FOLLOWING OPEN ABDOMINAL AORTIC ANEURYSM REPAIR, WHICH REFERENCED AN UNKNOWN PATIENT TAKING GELFOAM AND EXPERIENCED STERILE MEDIASTINAL GAS WAS IDENTIFIED IN THE REFERENCE SECTION. THE ARTICLE THAT FULLY DISCUSSES THIS PATIENT IS FOUND IN THE CHEST, 1992, VOL 102(6); PP 1911-13, ENTITLED STERILE MEDIASTINAL GAS MIMICKING ABSCESS IN AORTIC ANEURYSM REPAIR. THE FULL PUBLICATION OF THE REFERENCE ARTICLE HAS BEEN REQUESTED. A CASE REPORT DID LOOK AT THE POSSIBLE ROLE OF GELFOAM IN A PATIENT WHO PRESENTED 6 WEEKS POSTOPERATIVELY AFTER AN OPEN ASCENDING AORTIC ANEURYSM REPAIR WITH A 1-WEEK HISTORY OF NIGHT SWEATS, FEVER, AND CHILLS, WHOM THEY SUSPECTED OF HAVING AN ABSCESS AT THE SITE OF REPAIR. AFTER AN EXTENSIVE WORKUP, INCLUDING A NEGATIVE WBC SCAN AND NEGATIVE EXPLORATORY LAPAROTOMY, THEY CONCLUDED THAT THE REGION OF EXTENSIVE ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE CORRESPONDED TO THE SITE OF THE GAS COLLECTION DEMONSTRATED, AND LIKELY THE CAUSATION OF POSTOPERATIVE AIR. FOLLOW-UP (31MAY2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: 2019-05-0036188-US). SEVERITY LEVEL, HAZARDOUS SITUATION AND P2 VALUE. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH REASONABLE OF A MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY OF S5, AND THEREFORE REQUIRES ESCALATION TO PFIZER US SAFETY. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. THE COMPLAINT VERBATIM IS AS FOLLOWS: "AORTIC GRAFT INFECTION IS A FEARED COMPLICATION AFTER OPEN ABDOMINAL AORTIC ANEURYSM REPAIR SECONDARY TO ITS HIGH MORTALITY. PERIGRAFT AIR IS A COMMON FINDING AFTER OPEN AORTIC ANEURYSM REPAIR; HOWEVER, IT IS ALSO ASSOCIATED WITH AORTIC GRAFT INFECTION. DELINEATING BETWEEN GRAFT INFECTION AND COMMON POSTOPERATIVE FINDING IS A CHALLENGE. THIS IS FURTHER COMPLICATED BY USE OF HEMOSTATIC AGENTS SUCH AS GELFOAM, WHICH IS ALSO DOCUMENTED TO CAUSE PERIGRAFT AIR. CORRECT DIAGNOSIS HAS CRUCIAL IMPLICATIONS IN MANAGEMENT OF POTENTIAL AORTIC GRAFT INFECTION, WHICH IS A VASCULAR EMERGENCY. WE REPORT A CASE OF PERIGRAFT AIR IN A PATIENT STATUS AFTER OPEN AORTIC ANEURYSM REPAIR WITH ASSOCIATED CLINICAL MANIFESTATIONS OF INFECTION IN WHOM CONSERVATIVE MANAGEMENT AND SURVEILLANCE WAS SELECTED FOR TREATMENT. WE THEN DISCUSS THE TIMELINE OF PERIGRAFT AIR, POTENTIAL CAUSATION, IMPORTANCE OF HISTORY, AND PHYSICAL EXAMINATION, AND FINALLY, WE DISCUSS HOW SPECIFIC FINDINGS ON COMPUTED TOMOGRAPHY IMAGING FOR INFECTION IN OTHER AREAS MAY BE USEFUL IN AORTIC GRAFT INFECTION." HAZARDOUS SITUATION (WORST CASE SEVERITY S5): PATHOGEN CONTAMINATION (BACTERIAL, VIRAL, FUNGAL, PROTISTIC, OR OTHER HIGHLY RESISTANT PATHOGENS). HAZARD NUMBER: H02-01. P2 VALUE FOR A SEVERITY OF S3: 0.789; P2 VALUE FOR A SEVERITY OF S4: 0.21; P2 VALUE FOR A SEVERITY OF S5: 0. FOLLOW-UP (13JUL2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS GROUP. 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. PGS DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. AN EXPANDED TIME PERIOD WAS USED FOR THE ANALYSIS OF TRENDING TO CAPTURE COMPLAINTS THAT HAVE BEEN RECEIVED BY PFIZER KALAMAZOO AS A RESULT OF A REMEDIATION EFFORT BY PFIZER US SAFETY, THEIR FULL RANGE OF COMPLAINT CONTACT DATES, AND THE ASSOCIATED PRODUCT EXPIRY WINDOWS. 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, THIS IS DUE TO THE REMEDIATION EFFORT NOTED ABOVE. 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 REMEDIATION BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATIONS ROOT CAUSE: PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. A REVIEW OF THE APRR REPORTS, DEVIATIONS, AND AN EVALUATION OF TRENDS INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. IMPACT ANALYSIS: BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDED THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. 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 IS NOT REQUIRED. FOLLOW-UP (12JUL2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: PQC-2019-05-8934141-US), FOR ABSORBABLE GELATIN (GELFOAM). PR ID WAS 3941357 REPORTING REASONABLY SUGGEST DEVICE MALFUNCTION WAS YES, SEVERITY OF HARM WAS S5, COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION, COMPLAINT SUB-CLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE EXCLUDED. PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. NO CORRECTIVE ACTION OR FURTHER ACTION REQUIRED PER INVESTIGATION RESULT., COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE EXCLUDED. PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. NO CORRECTIVE ACTION OR FURTHER ACTION REQUIRED PER INVESTIGATION RESULT.
STERILE MEDIASTINAL GAS [PNEUMOMEDIASTINUM]. CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE RADIOLOGY CASE REPORTS, 2018, VOL 13(2); PP 343-346, ENTITLED PERIGRAFT AIR MIMICKING INFECTION ON CT ANGIOGRAPHY FOLLOWING OPEN ABDOMINAL AORTIC ANEURYSM REPAIR, WHICH REFERENCED AN UNKNOWN PATIENT TAKING GELFOAM AND EXPERIENCED STERILE MEDIASTINAL GAS WAS IDENTIFIED IN THE REFERENCE SECTION. THE ARTICLE THAT FULLY DISCUSSES THIS PATIENT IS FOUND IN THE CHEST, 1992, VOL 102(6); PP 1911-13, ENTITLED STERILE MEDIASTINAL GAS MIMICKING ABSCESS IN AORTIC ANEURYSM REPAIR. THE FULL PUBLICATION OF THE REFERENCE ARTICLE HAS BEEN REQUESTED. A CASE REPORT DID LOOK AT THE POSSIBLE ROLE OF GELFOAM IN A PATIENT WHO PRESENTED 6 WEEKS POSTOPERATIVELY AFTER AN OPEN ASCENDING AORTIC ANEURYSM REPAIR WITH A 1-WEEK HISTORY OF NIGHT SWEATS, FEVER, AND CHILLS, WHOM THEY SUSPECTED OF HAVING AN ABSCESS AT THE SITE OF REPAIR. AFTER AN EXTENSIVE WORKUP, INCLUDING A NEGATIVE WBC SCAN AND NEGATIVE EXPLORATORY LAPAROTOMY, THEY CONCLUDED THAT THE REGION OF EXTENSIVE ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE CORRESPONDED TO THE SITE OF THE GAS COLLECTION DEMONSTRATED, AND LIKELY THE CAUSATION OF POSTOPERATIVE AIR. FOLLOW-UP (31MAY2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4). SEVERITY LEVEL, HAZARDOUS SITUATION AND P2 VALUE. A COMPLAINT HAS BEEN RECEIVED BY PFIZER WITH REASONABLE OF A MALFUNCTION WITH AN ASSOCIATED WORST CASE SEVERITY OF S5, AND THEREFORE REQUIRES ESCALATION TO PFIZER US SAFETY. IMPACT TO THE DEVICE: POSSIBLE ADVERSE EVENT. THE COMPLAINT IS AS FOLLOWS: "AORTIC GRAFT INFECTION IS A FEARED COMPLICATION AFTER OPEN ABDOMINAL AORTIC ANEURYSM REPAIR SECONDARY TO ITS HIGH MORTALITY. PERIGRAFT AIR IS A COMMON FINDING AFTER OPEN AORTIC ANEURYSM REPAIR; HOWEVER, IT IS ALSO ASSOCIATED WITH AORTIC GRAFT INFECTION. DELINEATING BETWEEN GRAFT INFECTION AND COMMON POSTOPERATIVE FINDING IS A CHALLENGE. THIS IS FURTHER COMPLICATED BY USE OF HEMOSTATIC AGENTS SUCH AS GELFOAM, WHICH IS ALSO DOCUMENTED TO CAUSE PERIGRAFT AIR. CORRECT DIAGNOSIS HAS CRUCIAL IMPLICATIONS IN MANAGEMENT OF POTENTIAL AORTIC GRAFT INFECTION, WHICH IS A VASCULAR EMERGENCY. WE REPORT A CASE OF PERIGRAFT AIR IN A PATIENT STATUS AFTER OPEN AORTIC ANEURYSM REPAIR WITH ASSOCIATED CLINICAL MANIFESTATIONS OF INFECTION IN WHOM CONSERVATIVE MANAGEMENT AND SURVEILLANCE WAS SELECTED FOR TREATMENT. WE THEN DISCUSS THE TIMELINE OF PERIGRAFT AIR, POTENTIAL CAUSATION, IMPORTANCE OF HISTORY, AND PHYSICAL EXAMINATION, AND FINALLY, WE DISCUSS HOW SPECIFIC FINDINGS ON COMPUTED TOMOGRAPHY IMAGING FOR INFECTION IN OTHER AREAS MAY BE USEFUL IN AORTIC GRAFT INFECTION." HAZARDOUS SITUATION (WORST CASE SEVERITY S5): PATHOGEN CONTAMINATION (BACTERIAL, VIRAL, FUNGAL, PROTISTIC, OR OTHER HIGHLY RESISTANT PATHOGENS). HAZARD NUMBER: H02-01. P2 VALUE FOR A SEVERITY OF S3: 0.789; P2 VALUE FOR A SEVERITY OF S4: 0.21; P2 VALUE FOR A SEVERITY OF S5: 0. FOLLOW-UP (13JUL2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS GROUP. 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. PGS DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. AN EXPANDED TIME PERIOD WAS USED FOR THE ANALYSIS OF TRENDING TO CAPTURE COMPLAINTS THAT HAVE BEEN RECEIVED BY PFIZER KALAMAZOO AS A RESULT OF A REMEDIATION EFFORT BY PFIZER US SAFETY, THEIR FULL RANGE OF COMPLAINT CONTACT DATES, AND THE ASSOCIATED PRODUCT EXPIRY WINDOWS. 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, THIS IS DUE TO THE REMEDIATION EFFORT NOTED ABOVE. 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 REMEDIATION BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATIONS ROOT CAUSE: PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. A REVIEW OF THE APRR REPORTS, DEVIATIONS, AND AN EVALUATION OF TRENDS INDICATED THAT ALL GELFOAM BATCHES RELEVANT TO THIS INVESTIGATION HAD MET ESTABLISHED REQUIREMENTS AT THE TIME OF RELEASE. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER SITE. IMPACT ANALYSIS: BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO CONCLUDED THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE ACTION: THERE WERE NO CORRECTIVE ACTIONS IDENTIFIED AS A RESULT OF THIS COMPLAINT INVESTIGATION. 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 IS NOT REQUIRED. FOLLOW-UP (12JUL2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4), FOR ABSORBABLE GELATIN (GELFOAM). PR ID WAS (B)(6) REPORTING REASONABLY SUGGEST DEVICE MALFUNCTION WAS YES, SEVERITY OF HARM WAS S5, COMPLAINT CLASS: EXTERNAL CAUSE INVESTIGATION, COMPLAINT SUB-CLASS: ADVERSE EVENT SAFETY REQUEST FOR INVESTIGATION. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUSLY REPORTED INFORMATION: PRODUCT PROBLEM CHECKED ON THE MEDWATCH INFORMATION PAGE. FOLLOW-UP (22OCT2019 AND 23OCT2019): THIS IS A FOLLOW UP REPORT BASED ON INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4) AND (PRODUCT COMPLAINT NUMBER: (B)(4), FOR ABSORBABLE GELATIN (GELFOAM). SEVERITY OF HARM WAS S5. SAMPLES, PHOTOS WERE NOT AVAILABLE, SITE HAS NOT RECEIVED SAMPLE. PACKAGING RECORDS: COMPLETE -ACCEPTABLE. 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. PER REVIEW OF THE APRR REPORTS OVER THE EXPIRY INTERVAL REACHING BACK FROM THE RECEIPT OF THE COMPLIANT, THERE WERE NO BATCHES PRODUCED WITH ANALYTICAL TESTING RESULTS THAT WERE OUTSIDE OF REGISTERED SPECIFICATIONS PRIOR TO RELEASE. RSRV. SAMPLE EVALUATION WAS NOT REQUIRED AS THE BATCH NUMBER IS UNKNOWN. REFERENCE SAMPLE EXAMINATION: COMPLETE -ACCEPTABLE. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. CONCLUSION: BASED ON THE COMPLAINT NARRATIVE, THE PATIENT DEVELOPED PERIGRAFT AIR LEADING TO AN INFECTION/ABSCESS IN THE AREA OF PRODUCT USE. ALTHOUGH AIR TRAPPED BETWEEN TISSUES IMMEDIATELY AFTER A PROCEDURE IS A COMMON FINDING, INCREASE IN INFLAMMATORY MARKERS AND SYMPTOMS DURING THE LATER PHASE POST OPERATIVE, IS SUGGESTIVE OF AN INFECTION. THE OUTCOME OF THE EVENT IS UNKNOWN. REVIEW OF COMPLAINT DESCRIPTION CONCLUDES THERE IS NO DEVICE MALFUNCTION. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE COMPLETELY EXCLUDED. PRODUCT INVESTIGATION CONDUCTED. SAMPLE EVALUATION WAS NOT REQUIRED AS THE BATCH NUMBER IS UNKNOWN. REFERENCE SAMPLE EXAMINATION AND MEDICAL DEVICE TREND ANALYSIS WERE COMPLETE, AND ALL ACCEPTABLE. PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. NO CORRECTIVE ACTION OR FURTHER ACTION REQUIRED PER INVESTIGATION RESULT., COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE COMPLETELY EXCLUDED. PRODUCT INVESTIGATION CONDUCTED. SAMPLE EVALUATION WAS NOT REQUIRED AS THE BATCH NUMBER IS UNKNOWN. REFERENCE SAMPLE EXAMINATION AND MEDICAL DEVICE TREND ANALYSIS WERE COMPLETE, AND ALL ACCEPTABLE. PFIZER QUALITY OPERATIONS (QO) COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE SITE PRODUCTION PROCESS. NO CORRECTIVE ACTION OR FURTHER ACTION REQUIRED PER INVESTIGATION RESULT.
STERILE MEDIASTINAL GAS [PNEUMOMEDIASTINUM]. CASE NARRATIVE: THIS IS A LITERATURE REPORT FROM THE RADIOLOGY CASE REPORTS, 2018, VOL 13(2); PP 343-346, ENTITLED PERIGRAFT AIR MIMICKING INFECTION ON CT ANGIOGRAPHY FOLLOWING OPEN ABDOMINAL AORTIC ANEURYSM REPAIR, WHICH REFERENCED AN UNKNOWN PATIENT TAKING GELFOAM AND EXPERIENCED STERILE MEDIASTINAL GAS WAS IDENTIFIED IN THE REFERENCE SECTION. THE ARTICLE THAT FULLY DISCUSSES THIS PATIENT IS FOUND IN THE CHEST, 1992, VOL 102(6); PP 1911-13, ENTITLED STERILE MEDIASTINAL GAS MIMICKING ABSCESS IN AORTIC ANEURYSM REPAIR. THE FULL PUBLICATION OF THE REFERENCE ARTICLE HAS BEEN REQUESTED. A CASE REPORT DID LOOK AT THE POSSIBLE ROLE OF GELFOAM IN A PATIENT WHO PRESENTED 6 WEEKS POSTOPERATIVELY AFTER AN OPEN ASCENDING AORTIC ANEURYSM REPAIR WITH A 1-WEEK HISTORY OF NIGHT SWEATS, FEVER, AND CHILLS, WHOM THEY SUSPECTED OF HAVING AN ABSCESS AT THE SITE OF REPAIR. AFTER AN EXTENSIVE WORKUP, INCLUDING A NEGATIVE WBC SCAN AND NEGATIVE EXPLORATORY LAPAROTOMY, THEY CONCLUDED THAT THE REGION OF EXTENSIVE ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE CORRESPONDED TO THE SITE OF THE GAS COLLECTION DEMONSTRATED, AND LIKELY THE CAUSATION OF POSTOPERATIVE AIR. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED STERILE MEDIASTINAL GAS WAS MOST LIKELY DUE TO THE OPERATION ITSELF. HOWEVER, A CONTRIBUTION ROLE OF ABSORBABLE GELATIN SPONGE PACKING DURING THE INITIAL PROCEDURE TO THE ONSET OF THE EVENT CANNOT BE EXCLUDED. THIS CASE WILL BE REASSESSED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458479 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |