GELFOAM
Report
- Report Number
- 1810189-2020-00058
- Event Type
- Injury
- Date Received
- August 21, 2020
- Report Date
- August 11, 2020
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
FOLLOW-UP (25SEP2020): THIS IS A FOLLOW UP REPORT RECEIVED FROM THE PRODUCTS QUALITY COMPLAINTS GROUP (PQCG) WITH THE INVESTIGATION REPORT. DESCRIPTION OF COMPLAINT: HYDROCEPHALUS. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION. SEVERITY OF HARM WAS S5. PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; UDI-: (B)(4). FINAL CONFIRMATION STATUS: NOT CONFIRMED. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE 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 MANUFACTURING SITE. 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, SITE QUALITY OPERATIONS CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. REFERENCE SAMPLE EVALUATION: 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 WITHIN SCOPE WITH A KNOWN BATCH NUMBER FOR WHICH AN EVALUATION OF PREVIOUS RETAINED REFERENCE SAMPLE EXAMINATIONS COULD BE REVIEWED. 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. A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. 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: 21AUG2017 - 21AUG2020 -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 WAS ONE MONTH (APRIL 2019) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (11 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. COMPLAINT SAMPLE EVALUATION: SITE SAMPLE STATUS: NOT RECEIVED. PGS MANUFACTURING SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. FURTHER ACTION BY PFIZER MANUFACTURING SITE IS NOT REQUIRED. FOLLOW-UP (28SEP2020): THIS IS A FOLLOW-UP REPORT FROM THE PQCG. MALFUNCTION IS NOT PRESENT. SEVERITY OF HARM IS S3. FOLLOW-UP (09OCT2020): ADDITIONAL INFORMATION WAS RECEIVED FROM THE PQCG. 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 WAS DIMINISHED/ALTERED PRODUCT FUNCTION (HEMOSTASIS) (INX100314477V4.0), AND THE WORST CASE SEVERITY WAS S4. CONCLUSION REMAINS AS PREVIOUSLY REPORTED
DESCRIPTION OF COMPLAINT: HYDROCEPHALUS. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION. SEVERITY OF HARM WAS S5. PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; UDI-: (B)(4). FINAL CONFIRMATION STATUS: NOT CONFIRMED. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE 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 MANUFACTURING SITE. 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, SITE QUALITY OPERATIONS CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. REFERENCE SAMPLE EVALUATION: 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 WITHIN SCOPE WITH A KNOWN BATCH NUMBER FOR WHICH AN EVALUATION OF PREVIOUS RETAINED REFERENCE SAMPLE EXAMINATIONS COULD BE REVIEWED. 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. A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. 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: 21AUG2017 - 21AUG2020 -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 WAS ONE MONTH (APRIL 2019) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (11 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. COMPLAINT SAMPLE EVALUATION: SITE SAMPLE STATUS: NOT RECEIVED. PGS MANUFACTURING SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. FURTHER ACTION BY PFIZER MANUFACTURING SITE IS NOT REQUIRED. MALFUNCTION IS NOT PRESENT. SEVERITY OF HARM IS S3. 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 WAS DIMINISHED/ALTERED PRODUCT FUNCTION (HEMOSTASIS) (INX100314477V4.0), AND THE WORST CASE SEVERITY WAS S4. CONCLUSION REMAINS AS PREVIOUSLY REPORTED. ON 20NOV2020, SEVERITY OF HARM WAS S3. FAILURE MODE WAS GELFOAM MIGRATION. INVESTIGATION FINDINGS:SUMMARY OF INVESTIGATION: 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. MALFUNCTION IS NOT PRESENT IN THIS CASE (OFF-LABEL USE). 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 CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE SITE 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.
DESCRIPTION OF COMPLAINT: HYDROCEPHALUS. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION. SEVERITY OF HARM WAS S5. PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; UDI-: (B)(4). FINAL CONFIRMATION STATUS: NOT CONFIRMED. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE 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 MANUFACTURING SITE. 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-QUALITY OPERATIONS CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. 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. FURTHER ACTION BY PFIZER MANUFACTURING SITE IS NOT REQUIRED. REFERENCE SAMPLE EVALUATION: 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 WITHIN SCOPE WITH A KNOWN BATCH NUMBER FOR WHICH AN EVALUATION OF PREVIOUS RETAINED REFERENCE SAMPLE EXAMINATIONS COULD BE REVIEWED. 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. A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. 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: 21AUG2017 - 21AUG2020 -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 WAS ONE MONTH (APRIL 2019) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (11 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. COMPLAINT SAMPLE EVALUATION: SITE SAMPLE STATUS: NOT RECEIVED. PGS MANUFACTURING SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION.
DESCRIPTION OF COMPLAINT: HYDROCEPHALUS. MALFUNCTION IS NOT PRESENT. SEVERITY OF HARM IS S3. PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; UDI: (B)(4). FINAL CONFIRMATION STATUS: NOT CONFIRMED. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE 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 MANUFACTURING SITE. THERE IS NO INDICATION THAT THE DEVICES FAILED TO MEET REGISTERED SPECIFICATIONS. BASED UPON THE RESULTS OF THIS INVESTIGATION, PGS-QUALITY OPERATIONS CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. 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. FURTHER ACTION BY PFIZER MANUFACTURING SITE IS NOT REQUIRED.
EVENT VERBATIM [PREFERRED TERM] RECURRENT HYDROCEPHALUS, SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ETV FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV [HYDROCEPHALUS], NARRATIVE: THIS IS A LITERATURE REPORT FROM WORLD NEUROSURGERY, 2020, VOL 142; PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214), ENTITLED, "GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS". THE FULL PUBLICATION HAS BEEN REQUESTED. THIS AUTHOR REPORTED SIMILAR EVENTS FOR DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. A 12-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE/HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN AND PATIENT OUTCOME WERE UNKNOWN AT THE TIME OF REPORTING. FOLLOW-UP (12AUG2020): THIS IS A FOLLOW-UP TO A LITERATURE REPORT FROM WORLD NEUROSURGERY, 2020, VOL 142; PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214), ENTITLED "GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS". THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION. A 12-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM) , VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE/HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR, ADMITTED AFTER A 1- WEEK HISTORY OF HEADACHE, VISUAL LOSS, VOMITING, AND DIZZINESS. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. BRAIN MAGNETIC RESONANCE IMAGING (MRI) SHOWED A 4.5 CM X 4.6 CM POSTERIOR FOSSA TUMOR ARISING FROM THE MIDLINE, CHARACTERIZED BY LOW CELLULARITY AND MASS EFFECT ON THE FOURTH VENTRICLE WITH SUBSEQUENT SUPRATENTORIAL HYDROCEPHALUS (SAGITTAL T2-WEIGHTED MAGNETIC RESONANCE IMAGING (MRI) DISCLOSED A LARGE SOLID AND CYSTIC TUMOR IN THE FOURTH VENTRICLE WITH OBSTRUCTIVE SUPRATENTORIAL HYDROCEPHALUS). TUMOR REMOVAL WAS PERFORMED THROUGH A SUBOCCIPITAL CRANIOTOMY AND TRANSVERMIAN APPROACH. A PERIOPERATIVE EXTERNAL VENTRICULAR DRAIN WAS PLACED USING AN ANTIBIOTIC-IMPREGNATED CATHETER. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. PATHOLOGY SHOWED A PILOCYTIC ASTROCYTOMA. OWING TO THE PERSISTENCE OF HYDROCEPHALUS ON POSTOPERATIVE MRI (AFTER TUMOR RESECTION, MRI DOCUMENTED PERSISTENT HYDROCEPHALUS WITH SUBOCCIPITAL CEREBROSPINAL FLUID COLLECTION DESPITE 1 WEEK OF EXTERNAL VENTRICULAR DRAINAGE), WITH A LARGE AMOUNT OF CEREBROSPINAL FLUID (CSF) DRAINED PER DAY, STANDARD ETV WAS PERFORMED, AND GELFOAM WAS PLACED IN THE BURR HOLE AT THE END OF THE ENDOSCOPIC NAVIGATION. THE PATIENT WAS DISCHARGED 3 DAYS AFTER ETV IN GOOD CLINICAL CONDITION. SHE PRESENTED 2 WEEKS AFTER DISCHARGE WITH CSF LEAK FROM THE ETV SURGICAL WOUND AND HEADACHE. BRAIN MRI SHOWED THE ABSENCE OF CSF FLOW THROUGH THE ETV (MRI OBTAINED 2 WEEKS AFTER ETV DOCUMENTED A CLOSED STOMA). THE FAST IMAGING EMPLOYING STEADY-STATE ACQUISITION SEQUENCE REVEALED THE PRESENCE OF A NODULAR FORMATION ADHERING TO THE FLOOR OF THE THIRD VENTRICLE. A NEW ENDOSCOPIC APPROACH WAS PERFORMED TO CHECK FOR A POSSIBLE REDO ETV. DURING THE OPERATION, THE STOMA WAS OBSTRUCTED BY A FRAGMENT OF GELFOAM CONSOLIDATED WITH THE EDGES OF THE THIRD VENTRICLE FLOOR (ENDOSCOPIC PICTURE SHOWING THE FRAGMENT OF GELFOAM MIGRATED AND OBSTRUCTING THE THIRD VENTRICULOSTOMY (A) AND THE INFLAMMATORY MEMBRANE CLOSING THE STOMA (B) EVIDENT AFTER THE REMOVAL OF THE GELFOAM FRAGMENT). THIS OBSTACLE WAS REMOVED BY BIOPSY FORCEPS, WHICH WERE ALSO USED TO REOPEN THE VENTRICULAR FLOOR SO THAT THE CSF FLOW THROUGH THE STOMA RESTARTED. THE NEUROSURGICAL SPECIMEN WAS COMPOSED OF FRAGMENTS OF AMORPHOUS EOSINOPHILIC ACELLULAR MATERIAL (NEUROSURGICAL SPONGE DEBRIS) AND GRANULATION TISSUE RICH IN INFLAMMATORY CELLS, INCLUDING CD68- MACROPHAGES, PLASMA CELLS, CD45+ LYMPHOCYTES, AND GRANULOCYTES (HISTOPATHOLOGIC FEATURES. THE SMALL FRAGMENTS CONSISTED OF INFLAMMATORY CELLS RICH IN GRANULATION TISSUE BORDERED BY RESTS OF AMORPHOUS EOSINOPHILIC MATERIAL (NEUROSURGICAL SPONGE) ). A FEW MULTINUCLEATED GIANT CELLS WERE PRESENT. THE TISSUE DID NOT SHOW IMMUNOREACTIVITY FOR GLIAL FIBRILLARY ACIDIC PROTEIN AND OLIG2. POSTOPERATIVE MRI CONFIRMED THE PATENCY OF ETV (AFTER A SECOND ENDOSCOPIC PROCEDURE, THE PATENCY OF THIRD VENTRICULOSTOMY WAS CONFIRMED BY SAGITTAL T2-WEIGHTED MRI. GOOD CEREBROSPINAL FLUID FLOW WAS APPRECIABLE ON CINE MRI). THE PATIENT WAS ASYMPTOMATIC AT DISCHARGE. AT 8 MONTHS AFTER THE LAST SURGERY, SHE IS DOING WELL. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS RECOVERED. FOLLOW-UP (25SEP2020): THIS IS A FOLLOW UP REPORT RECEIVED FROM THE PRODUCTS QUALITY COMPLAINTS GROUP (PQCG) WITH THE INVESTIGATION REPORT. DESCRIPTION OF COMPLAINT: HYDROCEPHALUS. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION. SEVERITY OF HARM WAS S5. PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; UDI-: 10300100000000. FINAL CONFIRMATION STATUS: NOT CONFIRMED. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE 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 MANUFACTURING SITE. 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, SITE QUALITY OPERATIONS CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. REFERENCE SAMPLE EVALUATION: 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 WITHIN SCOPE WITH A KNOWN BATCH NUMBER FOR WHICH AN EVALUATION OF PREVIOUS RETAINED REFERENCE SAMPLE EXAMINATIONS COULD BE REVIEWED. 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. A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. 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: 21AUG2017 - 21AUG2020 -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 WAS ONE MONTH (APRIL 2019) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (11 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. COMPLAINT SAMPLE EVALUATION: SITE SAMPLE STATUS: NOT RECEIVED. PGS MANUFACTURING SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. FURTHER ACTION BY PFIZER MANUFACTURING SITE IS NOT REQUIRED. FOLLOW-UP (28SEP2020): THIS IS A FOLLOW-UP REPORT FROM THE PQCG. MALFUNCTION IS NOT PRESENT. SEVERITY OF HARM IS S3. FOLLOW-UP (09OCT2020): ADDITIONAL INFORMATION WAS RECEIVED FROM THE PQCG. 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 WAS DIMINISHED/ALTERED PRODUCT FUNCTION (HEMOSTASIS) (INX100314477V4.0), AND THE WORST CASE SEVERITY WAS S4. CONCLUSION REMAINS AS PREVIOUSLY REPORTED. COMPANY CLINICAL EVALUATION COMMENT: BASED ON INFORMATION CURRENTLY AVAILABLE, THE PATIENT HAD PRE-EXISTING HYDROCEPHALUS CAUSED BY UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. 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: BASED ON INFORMATION CURRENTLY AVAILABLE, THE PATIENT HAD PRE-EXISTING HYDROCEPHALUS CAUSED BY UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION. 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]. RECURRENT HYDROCEPHALUS, SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ETV FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV [HYDROCEPHALUS], NARRATIVE: THIS IS A LITERATURE REPORT FROM WORLD NEUROSURGERY, 2020, VOL 142; PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214), ENTITLED, "GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS". THE FULL PUBLICATION HAS BEEN REQUESTED. THIS AUTHOR REPORTED SIMILAR EVENTS FOR DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. A 12-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE/HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN AND PATIENT OUTCOME WERE UNKNOWN AT THE TIME OF REPORTING. FOLLOW-UP (12AUG2020): THIS IS A FOLLOW-UP TO A LITERATURE REPORT FROM WORLD NEUROSURGERY, 2020, VOL 142; PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214), ENTITLED "GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS". THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION. A 12-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE/HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR, ADMITTED AFTER A 1- WEEK HISTORY OF HEADACHE, VISUAL LOSS, VOMITING, AND DIZZINESS. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. BRAIN MAGNETIC RESONANCE IMAGING (MRI) SHOWED A 4.5 CM X 4.6 CM POSTERIOR FOSSA TUMOR ARISING FROM THE MIDLINE, CHARACTERIZED BY LOW CELLULARITY AND MASS EFFECT ON THE FOURTH VENTRICLE WITH SUBSEQUENT SUPRATENTORIAL HYDROCEPHALUS (SAGITTAL T2-WEIGHTED MAGNETIC RESONANCE IMAGING (MRI) DISCLOSED A LARGE SOLID AND CYSTIC TUMOR IN THE FOURTH VENTRICLE WITH OBSTRUCTIVE SUPRATENTORIAL HYDROCEPHALUS). TUMOR REMOVAL WAS PERFORMED THROUGH A SUBOCCIPITAL CRANIOTOMY AND TRANSVERMIAN APPROACH. A PERIOPERATIVE EXTERNAL VENTRICULAR DRAIN WAS PLACED USING AN ANTIBIOTIC-IMPREGNATED CATHETER. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. PATHOLOGY SHOWED A PILOCYTIC ASTROCYTOMA. OWING TO THE PERSISTENCE OF HYDROCEPHALUS ON POSTOPERATIVE MRI (AFTER TUMOR RESECTION, MRI DOCUMENTED PERSISTENT HYDROCEPHALUS WITH SUBOCCIPITAL CEREBROSPINAL FLUID COLLECTION DESPITE 1 WEEK OF EXTERNAL VENTRICULAR DRAINAGE), WITH A LARGE AMOUNT OF CEREBROSPINAL FLUID (CSF) DRAINED PER DAY, STANDARD ETV WAS PERFORMED, AND GELFOAM WAS PLACED IN THE BURR HOLE AT THE END OF THE ENDOSCOPIC NAVIGATION. THE PATIENT WAS DISCHARGED 3 DAYS AFTER ETV IN GOOD CLINICAL CONDITION. SHE PRESENTED 2 WEEKS AFTER DISCHARGE WITH CSF LEAK FROM THE ETV SURGICAL WOUND AND HEADACHE. BRAIN MRI SHOWED THE ABSENCE OF CSF FLOW THROUGH THE ETV (MRI OBTAINED 2 WEEKS AFTER ETV DOCUMENTED A CLOSED STOMA). THE FAST IMAGING EMPLOYING STEADY-STATE ACQUISITION SEQUENCE REVEALED THE PRESENCE OF A NODULAR FORMATION ADHERING TO THE FLOOR OF THE THIRD VENTRICLE. A NEW ENDOSCOPIC APPROACH WAS PERFORMED TO CHECK FOR A POSSIBLE REDO ETV. DURING THE OPERATION, THE STOMA WAS OBSTRUCTED BY A FRAGMENT OF GELFOAM CONSOLIDATED WITH THE EDGES OF THE THIRD VENTRICLE FLOOR (ENDOSCOPIC PICTURE SHOWING THE FRAGMENT OF GELFOAM MIGRATED AND OBSTRUCTING THE THIRD VENTRICULOSTOMY (A) AND THE INFLAMMATORY MEMBRANE CLOSING THE STOMA (B) EVIDENT AFTER THE REMOVAL OF THE GELFOAM FRAGMENT). THIS OBSTACLE WAS REMOVED BY BIOPSY FORCEPS, WHICH WERE ALSO USED TO REOPEN THE VENTRICULAR FLOOR SO THAT THE CSF FLOW THROUGH THE STOMA RESTARTED. THE NEUROSURGICAL SPECIMEN WAS COMPOSED OF FRAGMENTS OF AMORPHOUS EOSINOPHILIC ACELLULAR MATERIAL (NEUROSURGICAL SPONGE DEBRIS) AND GRANULATION TISSUE RICH IN INFLAMMATORY CELLS, INCLUDING CD68- MACROPHAGES, PLASMA CELLS, CD45+ LYMPHOCYTES, AND GRANULOCYTES (HISTOPATHOLOGIC FEATURES. THE SMALL FRAGMENTS CONSISTED OF INFLAMMATORY CELLS RICH IN GRANULATION TISSUE BORDERED BY RESTS OF AMORPHOUS EOSINOPHILIC MATERIAL (NEUROSURGICAL SPONGE) ). A FEW MULTINUCLEATED GIANT CELLS WERE PRESENT. THE TISSUE DID NOT SHOW IMMUNOREACTIVITY FOR GLIAL FIBRILLARY ACIDIC PROTEIN AND OLIG2. POSTOPERATIVE MRI CONFIRMED THE PATENCY OF ETV (AFTER A SECOND ENDOSCOPIC PROCEDURE, THE PATENCY OF THIRD VENTRICULOSTOMY WAS CONFIRMED BY SAGITTAL T2-WEIGHTED MRI. GOOD CEREBROSPINAL FLUID FLOW WAS APPRECIABLE ON CINE MRI). THE PATIENT WAS ASYMPTOMATIC AT DISCHARGE. AT 8 MONTHS AFTER THE LAST SURGERY, SHE IS DOING WELL. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS RECOVERED. FOLLOW-UP (25SEP2020): THIS IS A FOLLOW UP REPORT RECEIVED FROM THE PRODUCTS QUALITY COMPLAINTS GROUP (PQCG) WITH THE INVESTIGATION REPORT. DESCRIPTION OF COMPLAINT: HYDROCEPHALUS. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION. SEVERITY OF HARM WAS S5. PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; UDI-: (B)(4). FINAL CONFIRMATION STATUS: NOT CONFIRMED. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE 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 MANUFACTURING SITE. 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, SITE QUALITY OPERATIONS CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. ALL REVIEWED RECORDS, TRENDS, AND IN-PROCESS CONTROLS WERE ACCEPTABLE, AND HAVE MET THE ESTABLISHED REQUIREMENTS. REFERENCE SAMPLE EVALUATION: 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 WITHIN SCOPE WITH A KNOWN BATCH NUMBER FOR WHICH AN EVALUATION OF PREVIOUS RETAINED REFERENCE SAMPLE EXAMINATIONS COULD BE REVIEWED. 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. A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. 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: (B)(6) 2017 - (B)(6) 2020 -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 WAS ONE MONTH ((B)(6) 2019) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS ((B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (11 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. COMPLAINT SAMPLE EVALUATION: SITE SAMPLE STATUS: NOT RECEIVED. PGS MANUFACTURING SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. CONCLUSION: THE REVIEW OF ALL RECORDS AND REPORTS WITHIN SCOPE OF THIS INVESTIGATION DEMONSTRATED THE ACCEPTABILITY OF THE PRODUCT OVER THE TIMEFRAME WITHIN SCOPE. FURTHER ACTION BY PFIZER MANUFACTURING SITE IS NOT REQUIRED. FOLLOW-UP (28SEP2020): THIS IS A FOLLOW-UP REPORT FROM THE PQCG. MALFUNCTION IS NOT PRESENT. SEVERITY OF HARM IS S3. FOLLOW-UP (09OCT2020): ADDITIONAL INFORMATION WAS RECEIVED FROM THE PQCG. 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 WAS DIMINISHED/ALTERED PRODUCT FUNCTION (HEMOSTASIS) (INX100314477V4.0), AND THE WORST CASE SEVERITY WAS S4. CONCLUSION REMAINS AS PREVIOUSLY REPORTED. FOLLOW-UP (20NOV2020): NEW INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS (PRODUCT COMPLAINT NUMBER: (B)(4)), FOR ABSORBABLE GELATIN (GELFOAM) INCLUDED: INVESTIGATIONAL RESULTS. SEVERITY OF HARM WAS S3. FAILURE MODE WAS GELFOAM MIGRATION. INVESTIGATION FINDINGS:SUMMARY OF INVESTIGATION: 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. MALFUNCTION IS NOT PRESENT IN THIS CASE (OFF-LABEL USE). 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 CURRENT LABELING INDICATES THAT AN OFF-LABEL USE OF THE REPORTED PRODUCT IS PRESENT IN THIS CASE, FURTHER SUPPORTING THE CONCLUSION THAT CAPA IS NOT REQUIRED FOR THE REPORTED CASE. THE DETAILS OF THE REPORTED COMPLAINT HAVE BEEN FORWARDED TO THE SITE 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. COMPANY CLINICAL EVALUATION COMMENT: BASED ON INFORMATION CURRENTLY AVAILABLE, THE PATIENT HAD PRE-EXISTING HYDROCEPHALUS CAUSED BY UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. 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: BASED ON INFORMATION CURRENTLY AVAILABLE, THE PATIENT HAD PRE-EXISTING HYDROCEPHALUS CAUSED BY UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION. 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]. RECURRENT HYDROCEPHALUS, SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. [HYDROCEPHALUS], , NARRATIVE: THIS IS A LITERATURE REPORT FROM WORLD NEUROSURGERY, 2020, VOL 142, PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214), ENTITLED "GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS". THE FULL PUBLICATION HAS BEEN REQUESTED. THIS AUTHOR REPORTED SIMILAR EVENTS FOR DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. A 12-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE/HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP (12AUG2020): THIS IS A FOLLOW-UP TO A LITERATURE REPORT FROM WORLD NEUROSURGERY, 2020, VOL 142; PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214), ENTITLED "GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS". THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION. A 12-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM) , VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE/HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR, ADMITTED AFTER A 1- WEEK HISTORY OF HEADACHE, VISUAL LOSS, VOMITING, AND DIZZINESS. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. BRAIN MAGNETIC RESONANCE IMAGING (MRI) SHOWED A 4.5 CM X 4.6 CM POSTERIOR FOSSA TUMOR ARISING FROM THE MIDLINE, CHARACTERIZED BY LOW CELLULARITY AND MASS EFFECT ON THE FOURTH VENTRICLE WITH SUBSEQUENT SUPRATENTORIAL HYDROCEPHALUS (SAGITTAL T2-WEIGHTED MAGNETIC RESONANCE IMAGING (MRI) DISCLOSED A LARGE SOLID AND CYSTIC TUMOR IN THE FOURTH VENTRICLE WITH OBSTRUCTIVE SUPRATENTORIAL HYDROCEPHALUS). TUMOR REMOVAL WAS PERFORMED THROUGH A SUBOCCIPITAL CRANIOTOMY AND TRANSVERMIAN APPROACH. A PERIOPERATIVE EXTERNAL VENTRICULAR DRAIN WAS PLACED USING AN ANTIBIOTIC-IMPREGNATED CATHETER. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. PATHOLOGY SHOWED A PILOCYTIC ASTROCYTOMA. OWING TO THE PERSISTENCE OF HYDROCEPHALUS ON POSTOPERATIVE MRI (AFTER TUMOR RESECTION, MRI DOCUMENTED PERSISTENT HYDROCEPHALUS WITH SUBOCCIPITAL CEREBROSPINAL FLUID COLLECTION DESPITE 1 WEEK OF EXTERNAL VENTRICULAR DRAINAGE), WITH A LARGE AMOUNT OF CEREBROSPINAL FLUID (CSF) DRAINED PER DAY, STANDARD ETV WAS PERFORMED, AND GELFOAM WAS PLACED IN THE BURR HOLE AT THE END OF THE ENDOSCOPIC NAVIGATION. THE PATIENT WAS DISCHARGED 3 DAYS AFTER ETV IN GOOD CLINICAL CONDITION. SHE PRESENTED 2 WEEKS AFTER DISCHARGE WITH CSF LEAK FROM THE ETV SURGICAL WOUND AND HEADACHE. BRAIN MRI SHOWED THE ABSENCE OF CSF FLOW THROUGH THE ETV (MRI OBTAINED 2 WEEKS AFTER ETV DOCUMENTED A CLOSED STOMA). THE FAST IMAGING EMPLOYING STEADY-STATE ACQUISITION SEQUENCE REVEALED THE PRESENCE OF A NODULAR FORMATION ADHERING TO THE FLOOR OF THE THIRD VENTRICLE. A NEW ENDOSCOPIC APPROACH WAS PERFORMED TO CHECK FOR A POSSIBLE REDO ETV. DURING THE OPERATION, THE STOMA WAS OBSTRUCTED BY A FRAGMENT OF GELFOAM CONSOLIDATED WITH THE EDGES OF THE THIRD VENTRICLE FLOOR (ENDOSCOPIC PICTURE SHOWING THE FRAGMENT OF GELFOAM MIGRATED AND OBSTRUCTING THE THIRD VENTRICULOSTOMY (A) AND THE INFLAMMATORY MEMBRANE CLOSING THE STOMA (B) EVIDENT AFTER THE REMOVAL OF THE GELFOAM FRAGMENT). THIS OBSTACLE WAS REMOVED BY BIOPSY FORCEPS, WHICH WERE ALSO USED TO REOPEN THE VENTRICULAR FLOOR SO THAT THE CSF FLOW THROUGH THE STOMA RESTARTED. THE NEUROSURGICAL SPECIMEN WAS COMPOSED OF FRAGMENTS OF AMORPHOUS EOSINOPHILIC ACELLULAR MATERIAL (NEUROSURGICAL SPONGE DEBRIS) AND GRANULATION TISSUE RICH IN INFLAMMATORY CELLS, INCLUDING CD68- MACROPHAGES, PLASMA CELLS, CD45+ LYMPHOCYTES, AND GRANULOCYTES (HISTOPATHOLOGIC FEATURES. THE SMALL FRAGMENTS CONSISTED OF INFLAMMATORY CELLS RICH IN GRANULATION TISSUE BORDERED BY RESTS OF AMORPHOUS EOSINOPHILIC MATERIAL (NEUROSURGICAL SPONGE) ). A FEW MULTINUCLEATED GIANT CELLS WERE PRESENT. THE TISSUE DID NOT SHOW IMMUNOREACTIVITY FOR GLIAL FIBRILLARY ACIDIC PROTEIN AND OLIG2. POSTOPERATIVE MRI CONFIRMED THE PATENCY OF ETV (AFTER A SECOND ENDOSCOPIC PROCEDURE, THE PATENCY OF THIRD VENTRICULOSTOMY WAS CONFIRMED BY SAGITTAL T2-WEIGHTED MRI. GOOD CEREBROSPINAL FLUID FLOW WAS APPRECIABLE ON CINE MRI). THE PATIENT WAS ASYMPTOMATIC AT DISCHARGE. AT 8 MONTHS AFTER THE LAST SURGERY, SHE IS DOING WELL. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS RECOVERED. FOLLOW-UP (25SEP2020): THIS IS A FOLLOW UP REPORT RECEIVED FROM THE PRODUCTS QUALITY COMPLAINTS GROUP WITH THE INVESTIGATION REPORT. DESCRIPTION OF COMPLAINT: HYDROCEPHALUS. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION. SEVERITY OF HARM WAS S5. PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; UDI-: (B)(4). FINAL CONFIRMATION STATUS: NOT CONFIRMED. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE 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 MANUFACTURING SITE. 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-QUALITY OPERATIONS CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. 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. FURTHER ACTION BY PFIZER MANUFACTURING SITE IS NOT REQUIRED. REFERENCE SAMPLE EVALUATION: 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 WITHIN SCOPE WITH A KNOWN BATCH NUMBER FOR WHICH AN EVALUATION OF PREVIOUS RETAINED REFERENCE SAMPLE EXAMINATIONS COULD BE REVIEWED. 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. A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. 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: 21AUG2017 - 21AUG2020 -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 WAS ONE MONTH (APRIL 2019) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (11 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. COMPLAINT SAMPLE EVALUATION: SITE SAMPLE STATUS: NOT RECEIVED. PGS MANUFACTURING SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. COMPANY CLINICAL EVALUATION COMMENT: BASED ON INFORMATION CURRENTLY AVAILABLE, THE PATIENT HAD PRE-EXISTING HYDROCEPHALUS CAUSED BY UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. 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: BASED ON INFORMATION CURRENTLY AVAILABLE, THE PATIENT HAD PRE-EXISTING HYDROCEPHALUS CAUSED BY UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. 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.
RECURRENT HYDROCEPHALUS, SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ETV FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV [HYDROCEPHALUS]. NARRATIVE: THIS IS A LITERATURE REPORT FROM WORLD NEUROSURGERY, 2020, VOL 142, PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214), ENTITLED "GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS". THE FULL PUBLICATION HAS BEEN REQUESTED. THIS AUTHOR REPORTED SIMILAR EVENTS FOR DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. A 12-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE / HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP (12AUG2020): THIS IS A FOLLOW-UP TO A LITERATURE REPORT FROM WORLD NEUROSURGERY, 2020, VOL 142; PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214), ENTITLED "GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS". THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION. A 12-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM) , VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE/HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR, ADMITTED AFTER A 1- WEEK HISTORY OF HEADACHE, VISUAL LOSS, VOMITING, AND DIZZINESS. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. BRAIN MAGNETIC RESONANCE IMAGING (MRI) SHOWED A 4.5 CM X 4.6 CM POSTERIOR FOSSA TUMOR ARISING FROM THE MIDLINE, CHARACTERIZED BY LOW CELLULARITY AND MASS EFFECT ON THE FOURTH VENTRICLE WITH SUBSEQUENT SUPRATENTORIAL HYDROCEPHALUS (SAGITTAL T2-WEIGHTED MAGNETIC RESONANCE IMAGING (MRI) DISCLOSED A LARGE SOLID AND CYSTIC TUMOR IN THE FOURTH VENTRICLE WITH OBSTRUCTIVE SUPRATENTORIAL HYDROCEPHALUS). TUMOR REMOVAL WAS PERFORMED THROUGH A SUBOCCIPITAL CRANIOTOMY AND TRANSVERMIAN APPROACH. A PERIOPERATIVE EXTERNAL VENTRICULAR DRAIN WAS PLACED USING AN ANTIBIOTIC-IMPREGNATED CATHETER. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. PATHOLOGY SHOWED A PILOCYTIC ASTROCYTOMA. OWING TO THE PERSISTENCE OF HYDROCEPHALUS ON POSTOPERATIVE MRI (AFTER TUMOR RESECTION, MRI DOCUMENTED PERSISTENT HYDROCEPHALUS WITH SUBOCCIPITAL CEREBROSPINAL FLUID COLLECTION DESPITE 1 WEEK OF EXTERNAL VENTRICULAR DRAINAGE), WITH A LARGE AMOUNT OF CEREBROSPINAL FLUID (CSF) DRAINED PER DAY, STANDARD ETV WAS PERFORMED, AND GELFOAM WAS PLACED IN THE BURR HOLE AT THE END OF THE ENDOSCOPIC NAVIGATION. THE PATIENT WAS DISCHARGED 3 DAYS AFTER ETV IN GOOD CLINICAL CONDITION. SHE PRESENTED 2 WEEKS AFTER DISCHARGE WITH CSF LEAK FROM THE ETV SURGICAL WOUND AND HEADACHE. BRAIN MRI SHOWED THE ABSENCE OF CSF FLOW THROUGH THE ETV (MRI OBTAINED 2 WEEKS AFTER ETV DOCUMENTED A CLOSED STOMA). THE FAST IMAGING EMPLOYING STEADY-STATE ACQUISITION SEQUENCE REVEALED THE PRESENCE OF A NODULAR FORMATION ADHERING TO THE FLOOR OF THE THIRD VENTRICLE. A NEW ENDOSCOPIC APPROACH WAS PERFORMED TO CHECK FOR A POSSIBLE REDO ETV. DURING THE OPERATION, THE STOMA WAS OBSTRUCTED BY A FRAGMENT OF GELFOAM CONSOLIDATED WITH THE EDGES OF THE THIRD VENTRICLE FLOOR (ENDOSCOPIC PICTURE SHOWING THE FRAGMENT OF GELFOAM MIGRATED AND OBSTRUCTING THE THIRD VENTRICULOSTOMY (A) AND THE INFLAMMATORY MEMBRANE CLOSING THE STOMA (B) EVIDENT AFTER THE REMOVAL OF THE GELFOAM FRAGMENT). THIS OBSTACLE WAS REMOVED BY BIOPSY FORCEPS, WHICH WERE ALSO USED TO REOPEN THE VENTRICULAR FLOOR SO THAT THE CSF FLOW THROUGH THE STOMA RESTARTED. THE NEUROSURGICAL SPECIMEN WAS COMPOSED OF FRAGMENTS OF AMORPHOUS EOSINOPHILIC ACELLULAR MATERIAL (NEUROSURGICAL SPONGE DEBRIS) AND GRANULATION TISSUE RICH IN INFLAMMATORY CELLS, INCLUDING CD68- MACROPHAGES, PLASMA CELLS, CD45+ LYMPHOCYTES, AND GRANULOCYTES (HISTOPATHOLOGIC FEATURES. THE SMALL FRAGMENTS CONSISTED OF INFLAMMATORY CELLS RICH IN GRANULATION TISSUE BORDERED BY RESTS OF AMORPHOUS EOSINOPHILIC MATERIAL (NEUROSURGICAL SPONGE) ). A FEW MULTINUCLEATED GIANT CELLS WERE PRESENT. THE TISSUE DID NOT SHOW IMMUNOREACTIVITY FOR GLIAL FIBRILLARY ACIDIC PROTEIN AND OLIG2. POSTOPERATIVE MRI CONFIRMED THE PATENCY OF ETV (AFTER A SECOND ENDOSCOPIC PROCEDURE, THE PATENCY OF THIRD VENTRICULOSTOMY WAS CONFIRMED BY SAGITTAL T2-WEIGHTED MRI. GOOD CEREBROSPINAL FLUID FLOW WAS APPRECIABLE ON CINE MRI). THE PATIENT WAS ASYMPTOMATIC AT DISCHARGE. AT 8 MONTHS AFTER THE LAST SURGERY, SHE IS DOING WELL. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS RECOVERED. FOLLOW-UP (25SEP2020): THIS IS A FOLLOW UP REPORT RECEIVED FROM THE PRODUCTS QUALITY COMPLAINTS GROUP WITH THE INVESTIGATION REPORT. DESCRIPTION OF COMPLAINT: HYDROCEPHALUS. THERE WAS A REASONABLE SUGGESTION OF DEVICE MALFUNCTION. SEVERITY OF HARM WAS S5. PRODUCT-DESCRIPTION: GELFOAM STERILE SPONGE SIZE 50 X 4; UDI: (B)(4). FINAL CONFIRMATION STATUS: NOT CONFIRMED. ROOT CAUSE ANALYSIS: PFIZER QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE 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 MANUFACTURING SITE. 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-QUALITY OPERATIONS CONCLUDES THAT THE QUALITY OF THE PRODUCT ON THE MARKET REMAINS ACCEPTABLE. THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. 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. FURTHER ACTION BY PFIZER MANUFACTURING SITE IS NOT REQUIRED. REFERENCE SAMPLE EVALUATION: 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 WITHIN SCOPE WITH A KNOWN BATCH NUMBER FOR WHICH AN EVALUATION OF PREVIOUS RETAINED REFERENCE SAMPLE EXAMINATIONS COULD BE REVIEWED. 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. A REVIEW OF ALL PREVIOUS MEDICAL DEVICE REPORTS (MDR) WAS PERFORMED AS A PART OF THIS INVESTIGATION. 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: 21AUG2017 - 21AUG2020 -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 WAS ONE MONTH (APRIL 2019) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (25); HOWEVER, THIS WAS DUE TO THE REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASS OF 'ADVERSE EVENT/SERIOUS/UNKNOWN', AND THERE WERE TWO MONTHS (JANUARY AND MARCH 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (11 AND 13, RESPECTIVELY); HOWEVER, THESE WERE ALSO DUE TO AN ON-GOING REMEDIATION EFFORT BY PFIZER US SAFETY. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. COMPLAINT SAMPLE EVALUATION: SITE SAMPLE STATUS: NOT RECEIVED. PGS MANUFACTURING SITE DID NOT RECEIVE A RETURNED COMPLAINT SAMPLE, OR PHOTOGRAPHS, FOR EVALUATION. FOLLOW-UP (28SEP2020): THIS IS A FOLLOW-UP REPORT FROM THE PRODUCT QUALITY COMPLAINT GROUP. MALFUNCTION IS NOT PRESENT. SEVERITY OF HARM IS S3. COMPANY CLINICAL EVALUATION COMMENT: BASED ON INFORMATION CURRENTLY AVAILABLE, THE PATIENT HAD PRE-EXISTING HYDROCEPHALUS CAUSED BY UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. 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: BASED ON INFORMATION CURRENTLY AVAILABLE, THE PATIENT HAD PRE-EXISTING HYDROCEPHALUS CAUSED BY UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. 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.
RECURRENT HYDROCEPHALUS, SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. [HYDROCEPHALUS]. NARRATIVE: THIS IS A LITERATURE REPORT FROM THE WORLD NEUROSURGERY, 2020, VOL 142, PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214) ENTITLED GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS. THE FULL PUBLICATION HAS BEEN REQUESTED. THIS AUTHOR REPORTED SIMILAR EVENTS FOR DIFFERENT PATIENTS. THIS IS FIRST OF THE TWO REPORTS. A 12-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE / HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP (12AUG2020): THIS IS A LITERATURE REPORT FROM THE WORLD NEUROSURGERY, 2020, VOL 142; PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214), ENTITLED GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS. THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION. A 12-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM) , VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE / HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR, ADMITTED AFTER A 1- WEEK HISTORY OF HEADACHE, VISUAL LOSS, VOMITING, AND DIZZINESS. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. BRAIN MAGNETIC RESONANCE IMAGING (MRI) SHOWED A 4.5 CM X 4.6 CM POSTERIOR FOSSA TUMOR ARISING FROM THE MIDLINE, CHARACTERIZED BY LOW CELLULARITY AND MASS EFFECT ON THE FOURTH VENTRICLE WITH SUBSEQUENT SUPRATENTORIAL HYDROCEPHALUS (SAGITTAL T2-WEIGHTED MAGNETIC RESONANCE IMAGING (MRI) DISCLOSED A LARGE SOLID AND CYSTIC TUMOR IN THE FOURTH VENTRICLE WITH OBSTRUCTIVE SUPRATENTORIAL HYDROCEPHALUS). TUMOR REMOVAL WAS PERFORMED THROUGH A SUBOCCIPITAL CRANIOTOMY AND TRANSVERMIAN APPROACH. A PERIOPERATIVE EXTERNAL VENTRICULAR DRAIN WAS PLACED USING AN ANTIBIOTIC-IMPREGNATED CATHETER. THE POSTOPERATIVE COURSE WAS UNEVENTFUL. PATHOLOGY SHOWED A PILOCYTIC ASTROCYTOMA. OWING TO THE PERSISTENCE OF HYDROCEPHALUS ON POSTOPERATIVE MRI (AFTER TUMOR RESECTION, MRI DOCUMENTED PERSISTENT HYDROCEPHALUS WITH SUBOCCIPITAL CEREBROSPINAL FLUID COLLECTION DESPITE 1 WEEK OF EXTERNAL VENTRICULAR DRAINAGE), WITH A LARGE AMOUNT OF CEREBROSPINAL FLUID (CSF) DRAINED PER DAY, STANDARD ETV WAS PERFORMED, AND GELFOAM WAS PLACED IN THE BURR HOLE AT THE END OF THE ENDOSCOPIC NAVIGATION. THE PATIENT WAS DISCHARGED 3 DAYS AFTER ETV IN GOOD CLINICAL CONDITION. SHE PRESENTED 2 WEEKS AFTER DISCHARGE WITH CSF LEAK FROM THE ETV SURGICAL WOUND AND HEADACHE. BRAIN MRI SHOWED THE ABSENCE OF CSF FLOW THROUGH THE ETV (MRI OBTAINED 2 WEEKS AFTER ETV DOCUMENTED A CLOSED STOMA). THE FAST IMAGING EMPLOYING STEADY-STATE ACQUISITION SEQUENCE REVEALED THE PRESENCE OF A NODULAR FORMATION ADHERING TO THE FLOOR OF THE THIRD VENTRICLE. A NEW ENDOSCOPIC APPROACH WAS PERFORMED TO CHECK FOR A POSSIBLE REDO ETV. DURING THE OPERATION, THE STOMA WAS OBSTRUCTED BY A FRAGMENT OF GELFOAM CONSOLIDATED WITH THE EDGES OF THE THIRD VENTRICLE FLOOR (ENDOSCOPIC PICTURE SHOWING THE FRAGMENT OF GELFOAM MIGRATED AND OBSTRUCTING THE THIRD VENTRICULOSTOMY (A) AND THE INFLAMMATORY MEMBRANE CLOSING THE STOMA (B) EVIDENT AFTER THE REMOVAL OF THE GELFOAM FRAGMENT). THIS OBSTACLE WAS REMOVED BY BIOPSY FORCEPS, WHICH WERE ALSO USED TO REOPEN THE VENTRICULAR FLOOR SO THAT THE CSF FLOW THROUGH THE STOMA RESTARTED. THE NEUROSURGICAL SPECIMEN WAS COMPOSED OF FRAGMENTS OF AMORPHOUS EOSINOPHILIC ACELLULAR MATERIAL (NEUROSURGICAL SPONGE DEBRIS) AND GRANULATION TISSUE RICH IN INFLAMMATORY CELLS, INCLUDING CD68- MACROPHAGES, PLASMA CELLS, CD45+ LYMPHOCYTES, AND GRANULOCYTES (HISTOPATHOLOGIC FEATURES. THE SMALL FRAGMENTS CONSISTED OF INFLAMMATORY CELLS RICH IN GRANULATION TISSUE BORDERED BY RESTS OF AMORPHOUS EOSINOPHILIC MATERIAL (NEUROSURGICAL SPONGE) ). A FEW MULTINUCLEATED GIANT CELLS WERE PRESENT. THE TISSUE DID NOT SHOW IMMUNOREACTIVITY FOR GLIAL FIBRILLARY ACIDIC PROTEIN AND OLIG2. POSTOPERATIVE MRI CONFIRMED THE PATENCY OF ETV (AFTER A SECOND ENDOSCOPIC PROCEDURE, THE PATENCY OF THIRD VENTRICULOSTOMY WAS CONFIRMED BY SAGITTAL T2-WEIGHTED MRI. GOOD CEREBROSPINAL FLUID FLOW WAS APPRECIABLE ON CINE MRI). THE PATIENT WAS ASYMPTOMATIC AT DISCHARGE. AT 8 MONTHS AFTER THE LAST SURGERY, SHE IS DOING WELL. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS RECOVERED. COMPANY CLINICAL EVALUATION COMMENT: BASED ON INFORMATION CURRENTLY AVAILABLE, THE PATIENT HAD PRE-EXISTING HYDROCEPHALUS CAUSED BY UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. 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: BASED ON INFORMATION CURRENTLY AVAILABLE, THE PATIENT HAD PRE-EXISTING HYDROCEPHALUS CAUSED BY UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. 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.
SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. [HYDROCEPHALUS], NARRATIVE: THIS IS A LITERATURE REPORT FROM THE WORLD NEUROSURGERY, 2020, VOL 142, PP 212-217 (DOI: 10.1016/J.WNEU.2020.06.214) ENTITLED GELFOAM MIGRATION: A POTENTIAL CAUSE OF RECURRENT HYDROCEPHALUS. THE FULL PUBLICATION HAS BEEN REQUESTED. THIS AUTHOR REPORTED SIMILAR EVENTS FOR DIFFERENT PATIENTS. THIS IS FIRST OF THE TWO REPORTS. A (B)(6) FEMALE PATIENT STARTED TO RECEIVE ABSORBABLE GELATIN (GELFOAM), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE AT UNKNOWN DOSAGE USED TO SEAL THE BURR HOLE/HEMOSTATIC. MEDICAL HISTORY INCLUDED POSTERIOR FOSSA TUMOR. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV) FOR ASSOCIATED HYDROCEPHALUS, WHERE A PORTION OF GELFOAM (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. THE ACTION TAKEN IN RESPONSE TO THE EVENT FOR ABSORBABLE GELATIN WAS UNKNOWN. THE OUTCOME OF THE EVENT WAS UNKNOWN. COMPANY CLINICAL EVALUATION COMMENT: BASED ON INFORMATION CURRENTLY AVAILABLE, THE REPORTED EVENT HYDROCEPHALUS WAS LIKELY RELATED TO UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. THE 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., COMMENT: BASED ON INFORMATION CURRENTLY AVAILABLE, THE REPORTED EVENT HYDROCEPHALUS WAS LIKELY RELATED TO UNDERLYING FOSSA TUMOR FOR WHICH THE PATIENT UNDERWENT SURGERY FOR POSTERIOR FOSSA TUMOR REMOVAL AND ENDOSCOPIC THIRD VENTRICULOSTOMY (ETV), WHERE A PORTION OF ABSORBABLE GELATIN (GELFOAM) (USED TO SEAL THE BURR HOLE) MIGRATED UP TO CLOSE THE ETV. MIGRATION OF GELFOAM FRAGMENTS COULD POSSIBLY CAUSE OCCLUSION OF ETV OR SHUNT, LEADING TO HYDROCEPHALUS RECURRENCE, FOR WHICH A NEW ENDOSCOPIC PROCEDURE WAS REQUIRED. THE 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 |
|---|---|---|---|---|---|---|---|
| 900701 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Other| R |