ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2020-00064
- Event Type
- Injury
- Date Received
- August 31, 2020
- Report Date
- August 17, 2020
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(6) 2020: SITE SAMPLE STATUS WAS NOT RECEIVED. ROOT CAUSE: PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER KALAMAZOO SITE. QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S5. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE / PREVENTIVE ACTION: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE KALAMAZOO MDCP TEAM FOR REVIEW. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER KALAMAZOO IS NOT REQUIRED. SCOPE OF COMPL. INVESTIGATION: ALL GELFOAM SPONGE AND GELFOAM POWDER COMPLAINTS RECEIVED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT WERE CONSIDERED TO BE IN SCOPE. A QUERY OF THE COMPLAINTS DATABASE FOR THE REPORTED PRODUCT, CLASS, AND SUB-LASS CAPTURED THE REQUIRED 5 DATA POINTS FOR THE REPORTED PRODUCT, CLASS, AND SUB-CLASS. OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. 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; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT NEGLIGIBLE/MINOR', AND THERE WAS ONE MONTH (B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 ); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION.
ON (07OCT2020): THIS IS A FOLLOW-UP REPORT FROM PFIZER PRODUCT QUALITY GROUP (PQCG) PROVIDING INVESTIGATION RESULTS. ROOT CAUSE: PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER KALAMAZOO SITE. QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEWOF THE DEVICE RISK FILE FOR THE PRODUCT WAS S5. REGULATORY REPORTABILITY IS ASSESSED BY THE DEVICE COMPLAINT HANDLING UNIT (DCHU). THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE / PREVENTIVE ACTION: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE KALAMAZOO MDCP TEAM FOR REVIEW. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. SCOPE OF COMPL. INVESTIGATION: ALL GELFOAM SPONGE AND GELFOAM POWDER COMPLAINTS RECEIVED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT WERE CONSIDERED TO BE IN SCOPE. A QUERY OF THE COMPLAINTS DATABASE FOR THE REPORTED PRODUCT, CLASS, AND SUB-LASS CAPTURED THE REQUIRED 5 DATA POINTS FOR THE REPORTED PRODUCT, CLASS, AND SUB-CLASS. OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. 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; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (B)(6) 2020 THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT NEGLIGIBLE/MINOR', AND THERE WAS ONE MONTH (B)(6) 2020 THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 ); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. ON (07JAN2021): THIS IS A FOLLOW-UP REPORT FROM PQCG PROVIDING DCHU SUMMARY INVESTIGATION DETAIL AND REGULATORY REPORTABILITY ASSESSMENT. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION WITH SEVERITY OF HARM: S4. GELFOAM IS REPORTABLE FOR A SERIOUS INJURY THAT NECESSITATES MEDICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE FOR THE US. IF IT WERE TO RECUR IT MIGHT LEAD TO A SERIOUS DETERIORATION IN HEALTH FOR ROW. THIS PRODUCT IS USED FOR TREATMENT. THIS IS 30-DAY REPORTABLE IN THE US AND 15-DAY FOR ROW.
EVENT VERBATIM [PREFERRED TERM] INTRAUTERINE INFECTION [INTRAUTERINE INFECTION], RECEIVED ABSORBABLE GELATIN (MEDICATED SPONGE) AS UTERINE ARTERY EMBOLIZATION FOR POSTPARTUM HAEMORRHAGE [OFF LABEL USE], RECEIVED ABSORBABLE GELATIN (MEDICATED SPONGE) AS UTERINE ARTERY EMBOLIZATION FOR POSTPARTUM HAEMORRHAGE [PRODUCT USE IN UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FROM THE ADV OBSTET GYNECOL, 2020, VOL 72(3); PAGE 224-229 ENTITLED "A RETROSPECTIVE SINGLE-CENTER STUDY OF UTERINE ARTERY EMBOLIZATION EFFICACY FOR POSTPARTUM HAEMORRHAGE WITH DISSEMINATED INTRAVASCULAR COAGULATION". THE AUTHOR REPORTED FOR 5 SUBJECTS. THIS IS THE 2ND OF 5 REPORTS. UTERINE ARTERY EMBOLIZATION (UAE) IS AN EFFECTIVE TREATMENT FOR POSTPARTUM HAEMORRHAGE (PPH), BUT CLINICAL FAILURE CAN OCCUR IN THE PRESENCE OF UNSTABLE HEMODYNAMICS AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). THEREFORE, THE AUTHORS AIMED TO CLARIFY THE USEFULNESS AND SAFETY OF UAE FOR THE TREATMENT OF PPH WITH DIC. THE STUDY INCLUDED 26 SUBJECTS WHO UNDERWENT UAE FOR PPH AT THE AUTHORS' CENTER BETWEEN 2013 AND 2018. SUBJECT CHARACTERISTICS, CLINICAL COURSES, UTERINE ARTERY EMBOLIZATION EFFICACY AND COMPLICATIONS WERE ALSO INVESTIGATED. IN TOTAL, 22 SUBJECTS HAD AN OBSTETRIC DIC SCORE OF 8 OR MORE (HEREINAFTER REFERRED TO AS DIC GROUP) AND FOUR SUBJECTS HAD AN OBSTETRIC DIC SCORE OF 7 OR LESS (HEREINAFTER REFERRED TO AS NON-DIC GROUP). SUCCESSFUL HAEMOSTASIS WAS OBSERVED IN 20 (90.9%) SUBJECTS IN THE DIC GROUP AND FOUR (100%) SUBJECTS IN THE NON-DIC GROUP, WITH NO SIGNIFICANT DIFFERENCE. THERE WERE TWO SERIOUS COMPLICATIONS IN THE DIC GROUP (ABDOMINAL AORTIC DISSECTION AND INTRAUTERINE INFECTION) AND ONE IN THE NON-DIC GROUP (UTERINE NECROSIS), BUT NONE REQUIRED INVASIVE TREATMENT. THE AUTHORS' RESULTS SUGGEST THAT UAE IS A RELATIVELY SAFE TREATMENT THAT CAN PROVIDE EFFECTIVE HAEMOSTASIS IN SUBJECTS WITH DIC. AN ADULT FEMALE SUBJECT RECEIVED ABSORBABLE GELATIN (MEDICATED SPONGE) AS UTERINE ARTERY EMBOLIZATION FOR POSTPARTUM HAEMORRHAGE. MEDICAL HISTORY INCLUDED POSTPARTUM HAEMORRHAGE, DISSEMINATED INTRAVASCULAR COAGULATION. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE SUBJECT EXPERIENCED INTRAUTERINE INFECTION. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THE ABDOMINAL AORTIC DISSECTION AND INCLUDED CONSERVATIVE TREATMENT. THE EVENT OUTCOME WAS RESOLVING. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES. FOLLOW-UP (07OCT2020): THIS IS A FOLLOW-UP REPORT FROM PFIZER PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. SITE SAMPLE STATUS WAS NOT RECEIVED. ROOT CAUSE: PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER KALAMAZOO SITE. QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S5. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. ADDITIONALLY, THE DETAILS OF THE COMPLAINT HAVE BEEN FORWARDED TO THE MDCP TEAM FOR REVIEW. THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE / PREVENTIVE ACTION: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE KALAMAZOO MDCP TEAM FOR REVIEW. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FURTHER ACTION BY PFIZER KALAMAZOO IS NOT REQUIRED. SCOPE OF COMPL. INVESTIGATION: ALL GELFOAM SPONGE AND GELFOAM POWDER COMPLAINTS RECEIVED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT WERE CONSIDERED TO BE IN SCOPE. A QUERY OF THE COMPLAINTS DATABASE FOR THE REPORTED PRODUCT, CLASS, AND SUB-LASS CAPTURED THE REQUIRED 5 DATA POINTS FOR THE REPORTED PRODUCT, CLASS, AND SUB-CLASS. OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. 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; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT NEGLIGIBLE/MINOR', AND THERE WAS ONE MONTH (B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 ); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION., COMMENT: THE REPORTED EVENT INTRAUTERINE INFECTION WAS ASSOCIATED WITH THE OFF LABEL USE OF ABSORBABLE GELATIN DURING UTERINE ARTERY EMBOLIZATION (UAE) FOR POSTPARTUM HAEMORRHAGE. OPERATION TECHNIQUE AND PATIENT STATUS INCLUDING THE HYPOPERFUSION INTO UTERUS CAUSED BY UNDERLYING POSTPARTUM HAEMORRHAGE WERE RISK FACTORS TO THE ONSET OF THE EVENT.
EVENT VERBATIM [PREFERRED TERM] RECEIVED ABSORBABLE GELATIN (MEDICATED SPONGE) AS UTERINE ARTERY EMBOLIZATION FOR POSTPARTUM HAEMORRHAGE [OFF LABEL USE], INTRAUTERINE INFECTION [INTRAUTERINE INFECTION], NARRATIVE: THIS IS A LITERATURE REPORT FROM THE ADV OBSTET GYNECOL, 2020, VOL 72(3); PP. 224-229, ENTITLED "A RETROSPECTIVE SINGLE-CENTER STUDY OF UTERINE ARTERY EMBOLIZATION EFFICACY FOR POSTPARTUM HAEMORRHAGE WITH DISSEMINATED INTRAVASCULAR COAGULATION". THE AUTHOR REPORTED FOR 5 SUBJECTS. THIS IS THE 2ND OF 5 REPORTS. UTERINE ARTERY EMBOLIZATION (UAE) IS AN EFFECTIVE TREATMENT FOR POSTPARTUM HAEMORRHAGE (PPH), BUT CLINICAL FAILURE CAN OCCUR IN THE PRESENCE OF UNSTABLE HEMODYNAMICS AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). THEREFORE, THE AUTHORS AIMED TO CLARIFY THE USEFULNESS AND SAFETY OF UAE FOR THE TREATMENT OF PPH WITH DIC. THE STUDY INCLUDED 26 SUBJECTS WHO UNDERWENT UAE FOR PPH AT THE AUTHORS' CENTER BETWEEN 2013 AND 2018. SUBJECT CHARACTERISTICS, CLINICAL COURSES, UTERINE ARTERY EMBOLIZATION EFFICACY AND COMPLICATIONS WERE ALSO INVESTIGATED. IN TOTAL, 22 SUBJECTS HAD AN OBSTETRIC DIC SCORE OF 8 OR MORE (HEREINAFTER REFERRED TO AS DIC GROUP) AND FOUR SUBJECTS HAD AN OBSTETRIC DIC SCORE OF 7 OR LESS (HEREINAFTER REFERRED TO AS NON-DIC GROUP). SUCCESSFUL HAEMOSTASIS WAS OBSERVED IN 20 (90.9%) SUBJECTS IN THE DIC GROUP AND FOUR (100%) SUBJECTS IN THE NON-DIC GROUP, WITH NO SIGNIFICANT DIFFERENCE. THERE WERE TWO SERIOUS COMPLICATIONS IN THE DIC GROUP (ABDOMINAL AORTIC DISSECTION AND INTRAUTERINE INFECTION) AND ONE IN THE NON-DIC GROUP (UTERINE NECROSIS), BUT NONE REQUIRED INVASIVE TREATMENT. THE AUTHORS' RESULTS SUGGEST THAT UAE IS A RELATIVELY SAFE TREATMENT THAT CAN PROVIDE EFFECTIVE HAEMOSTASIS IN SUBJECTS WITH DIC. AN ADULT FEMALE SUBJECT RECEIVED ABSORBABLE GELATIN (MEDICATED SPONGE) AS UTERINE ARTERY EMBOLIZATION FOLLOWING POSTPARTUM HAEMORRHAGE. MEDICAL HISTORY INCLUDED POSTPARTUM HAEMORRHAGE AND DISSEMINATED INTRAVASCULAR COAGULATION ON UNSPECIFIED DATES. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE SUBJECT EXPERIENCED INTRAUTERINE INFECTION. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THE EVENT OUTCOME WAS RESOLVING. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES. FOLLOW-UP (07OCT2020): THIS IS A FOLLOW-UP REPORT FROM PFIZER PRODUCT QUALITY GROUP (PQCG) PROVIDING INVESTIGATION RESULTS. ROOT CAUSE: PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER KALAMAZOO SITE. QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S5. REGULATORY REPORTABILITY IS ASSESSED BY THE DEVICE COMPLAINT HANDLING UNIT (DCHU). THE REGISTERED USE OF THIS PRODUCT IS FOR TREATMENT AND THE NATURE OF THIS COMPLAINT INDICATES THAT IT IS DIRECTLY RELATED TO THE DEVICE. HOWEVER, THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QO KALAMAZOO CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. CORRECTIVE / PREVENTIVE ACTION: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE KALAMAZOO MDCP TEAM FOR REVIEW. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF CORRECTIONS, OR CORRECTIVE OR PREVENTATIVE ACTIONS FOR THE REPORTED COMPLAINT. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. SCOPE OF COMPL. INVESTIGATION: ALL GELFOAM SPONGE AND GELFOAM POWDER COMPLAINTS RECEIVED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT WERE CONSIDERED TO BE IN SCOPE. A QUERY OF THE COMPLAINTS DATABASE FOR THE REPORTED PRODUCT, CLASS, AND SUB-LASS CAPTURED THE REQUIRED 5 DATA POINTS FOR THE REPORTED PRODUCT, CLASS, AND SUB-CLASS. OF THE COMPLAINT INVESTIGATIONS CAPTURED, THERE WERE NONE WITH A KNOWN BATCH NUMBER. 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; THEREFORE, THE REPORTED COMPLAINT WAS ESCALATED TO DCHU FOR EVALUATION OF REPORTABILITY. MEDICAL DEVICE TREND ANALYSIS: COMPLETE - ACCEPTABLE. USE OF THE PRODUCT CATEGORY OF 'ABSORBABLE MATERIAL' WAS REQUIRED TO CAPTURE HISTORICAL COMPLAINTS INVESTIGATED PRIOR TO MIGRATION INTO THE CURRENT COMPLAINT SYSTEM. THE PRODUCT CATEGORY OF 'DELIVERY SYSTEM' WAS USED TO CAPTURE COMPLAINTS RECEIVED WITHIN THE CURRENT DATABASE. THE RESULTS OF THE ABOVE QUERY WERE EVALUATED BY DATE CONTACTED AND BY THE CLASSIFICATION OF 'EXTERNAL CAUSE INVESTIGATION'. THERE WAS ONE MONTH (B)(6) 2020 THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT NEGLIGIBLE/MINOR', AND THERE WAS ONE MONTH (B)(6) 2020 THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (12 ); HOWEVER, THESE WERE ALSO DUE TO REMEDIATION EFFORTS BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. REGULATORY REPORTABILITY IS ASSESSED BY THE DCHU. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN SENT TO THE MDCP TEAM FOR REVIEW. FOLLOW-UP (07JAN2021): THIS IS A FOLLOW-UP REPORT FROM PQCG PROVIDING DCHU SUMMARY INVESTIGATION DETAIL AND REGULATORY REPORTABILITY ASSESSMENT. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION WITH SEVERITY OF HARM: S4. GELFOAM IS REPORTABLE FOR A SERIOUS INJURY THAT NECESSITATES MEDICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE FOR THE US. IF IT WERE TO RECUR IT MIGHT LEAD TO A SERIOUS DETERIORATION IN HEALTH FOR ROW. THIS PRODUCT IS USED FOR TREATMENT. THIS IS 30-DAY REPORTABLE IN THE US AND 15-DAY FOR ROW. COMPANY CLINICAL EVALUATION COMMENT: THE REPORTED EVENT INTRAUTERINE INFECTION WAS ASSOCIATED WITH THE OFF LABEL USE OF ABSORBABLE GELATIN DURING UTERINE ARTERY EMBOLIZATION (UAE) FOR POSTPARTUM HAEMORRHAGE. OPERATION TECHNIQUE AND PATIENT STATUS INCLUDING THE HYPOPERFUSION INTO UTERUS CAUSED BY UNDERLYING POSTPARTUM HAEMORRHAGE WERE RISK FACTORS TO THE ONSET OF THE EVENT. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE. NO FOLLOW-UP ATTEMPTS ARE NEEDED. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE REPORTED EVENT INTRAUTERINE INFECTION WAS ASSOCIATED WITH THE OFF LABEL USE OF ABSORBABLE GELATIN DURING UTERINE ARTERY EMBOLIZATION (UAE) FOR POSTPARTUM HAEMORRHAGE. OPERATION TECHNIQUE AND PATIENT STATUS INCLUDING THE HYPOPERFUSION INTO UTERUS CAUSED BY UNDERLYING POSTPARTUM HAEMORRHAGE WERE RISK FACTORS TO THE ONSET OF THE EVENT. NO CHANGE IN PREVIOUS ASSESSMENT BASED ON ADDITIONAL INFORMATION RECEIVED. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM] INTRAUTERINE INFECTION [INTRAUTERINE INFECTION], RECEIVED ABSORBABLE GELATIN (MEDICATED SPONGE) AS UTERINE ARTERY EMBOLIZATION FOR POSTPARTUM HAEMORRHAGE [OFF LABEL USE], RECEIVED ABSORBABLE GELATIN (MEDICATED SPONGE) AS UTERINE ARTERY EMBOLIZATION FOR POSTPARTUM HAEMORRHAGE [PRODUCT USE IN UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FROM ADV OBSTET GYNECOL, 2020, VOL 72(3); PAGE 224-229 ENTITLED "A RETROSPECTIVE SINGLE-CENTER STUDY OF UTERINE ARTERY EMBOLIZATION EFFICACY FOR POSTPARTUM HAEMORRHAGE WITH DISSEMINATED INTRAVASCULAR COAGULATION". THE AUTHOR REPORTED FOR 5 SUBJECTS. THIS IS THE 2ND OF 5 REPORTS. UTERINE ARTERY EMBOLIZATION (UAE) IS AN EFFECTIVE TREATMENT FOR POSTPARTUM HAEMORRHAGE (PPH), BUT CLINICAL FAILURE CAN OCCUR IN THE PRESENCE OF UNSTABLE HEMODYNAMICS AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). THEREFORE, THE AUTHORS AIMED TO CLARIFY THE USEFULNESS AND SAFETY OF UAE FOR THE TREATMENT OF PPH WITH DIC. THE STUDY INCLUDED 26 SUBJECTS WHO UNDERWENT UAE FOR PPH AT THE AUTHORS' CENTER BETWEEN 2013 AND 2018. SUBJECT CHARACTERISTICS, CLINICAL COURSES, UTERINE ARTERY EMBOLIZATION EFFICACY AND COMPLICATIONS WERE ALSO INVESTIGATED. IN TOTAL, 22 SUBJECTS HAD AN OBSTETRIC DIC SCORE OF 8 OR MORE (HEREINAFTER REFERRED TO AS DIC GROUP) AND FOUR SUBJECTS HAD AN OBSTETRIC DIC SCORE OF 7 OR LESS (HEREINAFTER REFERRED TO AS NON-DIC GROUP). SUCCESSFUL HAEMOSTASIS WAS OBSERVED IN 20 (90.9%) SUBJECTS IN THE DIC GROUP AND FOUR (100%) SUBJECTS IN THE NON-DIC GROUP, WITH NO SIGNIFICANT DIFFERENCE. THERE WERE TWO SERIOUS COMPLICATIONS IN THE DIC GROUP (ABDOMINAL AORTIC DISSECTION AND INTRAUTERINE INFECTION) AND ONE IN THE NON-DIC GROUP (UTERINE NECROSIS), BUT NONE REQUIRED INVASIVE TREATMENT. THE AUTHORS' RESULTS SUGGEST THAT UAE IS A RELATIVELY SAFE TREATMENT THAT CAN PROVIDE EFFECTIVE HAEMOSTASIS IN SUBJECTS WITH DIC. AN ADULT FEMALE SUBJECT RECEIVED ABSORBABLE GELATIN (MEDICATED SPONGE) AS UTERINE ARTERY EMBOLIZATION FOR POSTPARTUM HAEMORRHAGE. MEDICAL HISTORY INCLUDED POSTPARTUM HAEMORRHAGE, DISSEMINATED INTRAVASCULAR COAGULATION. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE SUBJECT EXPERIENCED INTRAUTERINE INFECTION. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF THE ABDOMINAL AORTIC DISSECTION AND INCLUDED CONSERVATIVE TREATMENT. THE EVENT OUTCOME WAS RESOLVING. PFIZER IS A MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN IN THE COUNTRY OF INCIDENCE OR THE COUNTRY WHERE THE PRODUCT WAS PURCHASED (IF DIFFERENT). THIS MAY BE A DUPLICATE REPORT IF ANOTHER MARKETING AUTHORIZATION HOLDER OF ABSORBABLE GELATIN HAS SUBMITTED THE SAME REPORT TO THE REGULATORY AUTHORITIES. COMMENT: THE REPORTED EVENT INTRAUTERINE INFECTION WAS ASSOCIATED WITH THE OFF LABEL USE OF ABSORBABLE GELATIN DURING UTERINE ARTERY EMBOLIZATION (UAE) FOR POSTPARTUM HAEMORRHAGE. OPERATION TECHNIQUE AND PATIENT STATUS INCLUDING THE HYPOPERFUSION INTO UTERUS CAUSED BY UNDERLYING POSTPARTUM HAEMORRHAGE WERE RISK FACTORS TO THE ONSET OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 939264 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |