GELFOAM
Report
- Report Number
- 1810189-2021-00018
- Event Type
- Injury
- Date Received
- May 11, 2021
- Report Date
- April 12, 2021
- Manufacturer
- PFIZER, INC. (DEVICE)
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION RESULTS RECEIVED ON (B)(6) 2021: SUMMARY OF INVESTIGATION: THE SCOPE OF THIS INVESTIGATION INCLUDED A REVIEW OF COMPLAINTS FOR GELFOAM SPONGE AND POWDER RECEIVED WITHIN 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER WERE IDENTIFIED. NO TRENDS WERE NOTED THAT WOULD REQUIRE ADDITIONAL INVESTIGATION. NO RETURNED COMPLAINT SAMPLE WAS RECEIVED. ROOT CAUSE ANALYSIS/IDENTIF: ROOT CAUSE: ROOT CAUSE: PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER KALAMAZOO SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. 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. IMPROVE/CONTROL: CORRECTIVE / PREVENTIVE ACTION: CORRECTIONS, CORRECTIVE AND PREVENTATIVE ACTIONS: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF 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 COMPLAINT FOR PERFORMANCE NOT AS INDICATED IN LABEL FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH.GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED THROUGH A FILTER WITH NITROGEN TO EXTRUDE THE LARGE, SOLID SPONGE BRICKS. THE BRICKS ARE DRIED, TRIMMED AND SPLIT. THE SPLIT BRICKS ARE THEN MILLED TO FORM POWDER. THE POWDER IS COLLECTED IN HIGH DENSITY POLYETHYLENE BAGS AND THEN SEALED INTO BULK CONTAINERS. THE GELFOAM POWDER IS THEN FILLED INTO INNER ENVELOPES USING A POWDER FILLING DEVICE. EACH ENVELOPE IS FILLED WITH A TARGET OF 1.2 GRAMS PER ENVELOPE AND A MINIMUM OF 1.0 GRAM PER ENVELOPE. TWO WEIGHT CHECKS OF EACH POWDER FILLING DEVICE ARE CONDUCTED AT 30 MINUTE INTERVALS TO ASSURE THAT THE DEVICE IS DISPENSING THE PROPER AMOUNT OF POWDER. THE FINAL PRODUCT YIELD IS CALCULATED AGAINST LIMITS FOR THE PRODUCT. THE INNER ENVELOPES ARE FOLDED OVER TWICE AND INSERTED INTO SLEEVES. THE FILLED SLEEVES ARE PLACED INTO TRAYS. THE SLEEVES (PEEL POUCHES) ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE ENVELOPES HAVE THE PROPER APPEARANCE, SEAL AND PRINT, AND ALL NOTED DEFECTIVE PRODUCT IS REMOVED FROM THE LOT PRIOR TO FINAL PACKAGING AND NO OPEN SIDE SEALS WERE OBSERVED. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. FOR GELFOAM SPONGE, THE BILL OF MATERIALS LISTS THE SPECIFIC PRODUCT COMPONENTS AND WEIGHTS REQUIRED FOR THE FORMULATION OF EACH BATCH. ALL MANUFACTURING MIXING SPEEDS, TIMES, AND TEMPERATURES HAVE SPECIFICATION CRITERIA. ALL EXTRUSION PARAMETERS HAVE REQUIRED SPECIFICATIONS. AFTER THE PRODUCT IS EXTRUDED INTO BRICKS, THE BRICKS ARE INSPECTED PRIOR TO BEING SLICED INTO INDIVIDUAL SPONGES. AFTER THE BRICKS ARE SLICED INTO SPONGES, A VISUAL INSPECTION IS PERFORMED FOR CONSISTENCY, UNIFORMITY, SHAPE, AND SIZE AT THE BEGINNING, MIDDLE, AND END OF SHIFTS AND EVERY FOUR HOURS IN BETWEEN. ALL DEFECTIVE SPONGES ARE IDENTIFIED AND REMOVED. THE GELFOAM IS PLACED INTO INNER ENVELOPES, AND TRANSFERRED TO THE DOYEN PACKAGING EQUIPMENT TO PACKAGE THE ENVELOPES INTO PEEL POUCHES. THE DOYEN TAKES SIX ENVELOPES PER ROTATION BY SUCTION AND LOADS THEM ONTO A CONVEYER BELT AGAINST AN ALIGNMENT TAB. TWO OPERATORS SIT AT THE DOYEN TO CORRECT ALIGNMENT ISSUES PRIOR TO SEALING. THE FRONT AND BACK PAPERS, WHICH MAKE UP THE OUTER PEEL POUCH, ENCLOSE EACH INDIVIDUAL INNER ENVELOPE ENTIRELY WITH A FOUR-SIDED, HEAT-ACTIVATED ADHESIVE SEAL. THE TOP, BOTTOM, AND SIDES OF THE OUTER PEEL POUCHES ARE SEALED BY THREE DIFFERENT PARTS OF THE DOYEN WHICH EACH HAVE SEPARATE TEMPERATURE CONTROLS. EACH TEMPERATURE CONTROL IS VERIFIED AND DOCUMENTED IN THE BATCH RECORD.THE PEEL POUCHES ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE PEEL POUCHES HAVE THE PROPER APPEARANCE, SEAL AND PRINT. A SEAL INTEGRITY TEST (SIT) IS UTILIZED THROUGHOUT THE FINAL PACKAGING TO ENSURE THE SIDE SEALS OF THE PEEL POUCHES ARE ACCEPTABLE. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON.AUDITS ARE PERFORMED ON THE FINISHED PACKAGED UNITS AT REGULAR INTERVALS THROUGHOUT THE FINAL PACKAGING PROCESS. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. QO BATCH HISTORY REPORT: A REVIEW OF RELEASE TESTING RESULTS COULD NOT BE PERFORMED AS THE REPORTED COMPLAINT BATCH IS UNKNOWN. 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 PRODUCT USE ATTRIBUTES. THERE WAS ONE MONTHS ((B)(6) 2021) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (7). A REVIEW OF THE 7 COMPLAINTS RECEIVED IN (B)(6) 2021 DETERMINED THAT ALL PERTAIN TO REVIEW OF A SINGLE LITERATURE ARTICLE, AND THE INVESTIGATIONS ARE IN PROGRESS, INCLUDING THE INVESTIGATION DOCUMENTED IN THIS RECORD. HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASSES OF LACK OF EFFECT AND 'PERFORMANCE NOT AS INDICATED IN LABEL TO REFLECT HISTORICAL CLASSIFICATIONS, AND THERE WERE TWO MONTHS ((B)(6) AND (B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (4 RECEIVED EACH MONTH, RESPECTIVELY). A REVIEW OF THE 8 COMPLAINTS RECEIVED DETERMINED THAT EACH WAS FOR AN UNKNOWN BATCH NUMBER, AND NONE WERE CONFIRMED OR PROCESS RELATED. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION.
EVENT VERBATIM [PREFERRED TERM]. GELFOAM FOR TRAUMATIC PSEUDOANEURYSM [OFF LABEL USE], CLINICAL FAILURE/PERSISTENT SPLENIC PA [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FROM CVIR ENDOVASCULAR, 2020, VOL 3 (1); DOI: 10.1186/S42155-020-00182-7, ENTITLED "ENDOVASCULAR MANAGEMENT OF TRAUMATIC PSEUDOANEURYSMS". THE AUTHOR REPORTED SIMILAR EVENTS FOR 5 PATIENTS. THIS IS THE 4TH OF 5 REPORTS (PATIENT OF UNSPECIFIED AGE AND GENDER WHO EXPERIENCED CLINICAL FAILURE AND UNDERWENT SPLENECTOMY FOR PERSISTENT SPLENIC PAS). METHODS: CLINICAL DATA WERE RETROSPECTIVELY COLLECTED FROM ALL PATIENTS PRESENTING FOR TREATMENT OF PAS BETWEEN (B)(6) 2012 AND (B)(6) 2018 AT A SINGLE ACADEMIC LEVEL ONE TRAUMA CENTER. INCLUSION CRITERIA WERE PATIENTS WHO HAD SUSTAINED TRAUMA, WHO HAD PA(S), AND WERE TREATED BY ENDOVASCULAR APPROACH WITH INTERVENTIONAL RADIOLOGY (IR). EXCLUSION CRITERIA WERE PA(S) OF NON-TRAUMATIC ORIGIN, CONTRAST EXTRAVASATION ON CT/ANGIOGRAM WITHOUT A DEFINED PSEUDOANEURYSM, DIFFUSE PA(S) IN THE HEAD/NECK OR CORONARY VESSELS, PARENCHYMAL HEMORRHAGE, OR LACERATION, AS DEFINED BY (REDACTED). PAS IDENTIFIED OR TREATED OVER 3 MONTHS AFTER TRAUMA WERE ALSO EXCLUDED TO BEST ENSURE A TRAUMATIC ETIOLOGY. PATIENT RECORDS WERE REVIEWED FOR DEMOGRAPHIC INFORMATION, TRAUMA TYPE (BLUNT VS. PENETRATING), TRANSFUSION REQUIREMENTS PRE- AND POSTTREATMENT, PA(S) LOCATION, PROCEDURAL TECHNIQUE, ADDITIONAL INTERVENTIONS, AND CLINICAL OUTCOMES, INCLUDING: LENGTH OF HOSPITALIZATION, ICU REQUIREMENTS, MORBIDITY, AND MORTALITY. ALL AVAILABLE PATIENT DATA WERE UTILIZED FOR THE FOLLOW-UP PERIOD. PROCEDURAL TECHNIQUE: ALL PATIENTS PRESENTING FOR TRAUMA (BLUNT OR LOCALIZED) UNDERWENT PRIMARY ASSESSMENT FOLLOWED BY CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CT) FOR VASCULAR EVALUATION. IMAGING INDICATIVE OR SUSPICIOUS FOR ARTERIAL DISRUPTION WAS REFERRED TO IR FOR INTERVENTION. ALL ENDOVASCULAR INTERVENTIONS WERE PERFORMED BY INTERVENTIONAL RADIOLOGISTS IN DEDICATED ENDOVASCULAR SUITES. INFORMED OR EMERGENCY CONSENT WAS OBTAINED AND SEDATION WAS PROVIDED BASED ON INDIVIDUAL PATIENT ASSESSMENT AND NEEDS, RANGING FROM MODERATE SEDATION TO GENERAL ANESTHESIA. ALL PATIENTS WERE PLACED SUPINE, WITH BOTH GROINS PREPPED AND DRAPED. PERCUTANEOUS ACCESS WAS OBTAINED UNDER ULTRASOUND GUIDANCE USING A STANDARD MICROPUNCTURE SET. SELDINGER TECHNIQUE WAS USED TO UPSIZE AND A 5 FRENCH (FR) VASCULAR SHEATH WAS INSERTED IN THE RIGHT OR LEFT COMMON FEMORAL ARTERIES. A STANDARD 5 FR CATHETER (E.G. COBRA 2 (MERIT MEDICAL, SALT LAKE CITY, UT, USA), ROBERTS UTERINE CATHETER (RUC) (COOK, BLOOMINGTON, IN, USA) OR SOS (ANGIODYNAMICS, LATHAM, NY, USA)) DEPENDING ON PATIENT ANATOMY AND PA LOCATION WAS SUBSEQUENTLY USED TO SELECTIVELY CATHETERIZE THE CULPRIT ARTERY ACCORDING TO CTA IMAGING AND ANGIOGRAPHY WAS THEN PERFORMED. COAXIAL TECHNIQUE WITH A MICROCATHETER WAS USED TO SUBSELECTIVELY CATHETERIZE THE PA ARTERY. TREATMENT WAS THEN PERFORMED WITH GELFOAM SLURRY (PFIZER, NEW YORK, NY, USA), COIL EMBOLIZATION, OR BOTH. FOLLOWING TREATMENT, POST-EMBOLIZATION ANGIOGRAPHY WAS PERFORMED. AT THE COMPLETION OF THE PROCEDURE, THE 5 FR CATHETER AND FEMORAL VASCULAR SHEATH WERE REMOVED AND HEMOSTASIS OBTAINED VIA A CLOSURE DEVICE OR MANUAL PRESSURE. STERILE DRESSING WAS APPLIED. TECHNICAL SUCCESS WAS DEFINED AS SUCCESSFUL TREATMENT OF THE PA WITH NO RESIDUAL FILLING ON POST-EMBOLIZATION ANGIOGRAM. CLINICAL SUCCESS WAS DEFINED AS TECHNICALLY SUCCESSFUL TREATMENT WITH NO REBLEEDING THROUGHOUT THE FOLLOW-UP PERIOD AND NO REINTERVENTION FOR THE PA. RESULTS: PATIENT CHARACTERISTICS: ONE HUNDRED FOUR PATIENTS WERE TREATED WITH INTERVENTIONAL RADIOLOGY (IR) BY ENDOVASCULAR MANAGEMENT FOR PAS OVER THE SIX-YEAR STUDY PERIOD. THIRTY-FIVE PATIENTS FULFILLED THE INCLUSION/EXCLUSION CRITERIA, WITH THE MAJORITY EXCLUDED FOR PAS OF NON-TRAUMATIC ETIOLOGY (E.G. PANCREATITIS, MALIGNANCY, OR IATROGENIC). FOLLOW-UP DATA AFTER TRAUMA HOSPITALIZATION RANGED FROM 0 DAYS-4.4 YRS. (MEDIAN: 44 DAYS; IQR: 2.3-205.5 DAYS). ALL 35 PATIENTS (10F/25M), AVERAGE AGE (+-STDEV) 41.7 +-20.1 YEARS, PRESENTING WITH BLUNT (N = 31) OR PENETRATING (N = 4) TRAUMA, UNDERWENT ENDOVASCULAR TREATMENT WITH IR. TIME FROM TRAUMA TO IR INTERVENTION RANGED FROM 2 H - 75 DAYS (MEDIAN: 4.4 H, IQR: 3.5-17.1 H) WITH 27 (77%) OF PAS IDENTIFIED AND TREATED WITHIN 24 H OF TRAUMA. AVERAGE HOSPITALIZATION WAS 13.78 +-13.4 DAYS. AVERAGE ICU STAY WAS 9.2 +-10.11 DAYS. TEN PATIENTS UNDERWENT A SURGICAL PROCEDURE PRIOR TO IR INTERVENTION. SEVEN OF THE SURGICAL TREATMENTS WERE PERFORMED NEAR THE SITE OF PA LOCATION. FOUR PATIENTS UNDERWENT ABDOMINAL EXPLORATORY LAPAROTOMY, FOLLOWED BY TREATMENT OF LIVER OR GASTROEPIPLOIC PAS. THREE PATIENTS UNDERWENT PELVIC EXPLORATION OR ORTHOPEDIC PELVIC/ FEMUR FRACTURE REPAIR AND WERE SUBSEQUENTLY TREATED FOR ILIAC OR FEMORAL PAS. FOUR OF SEVEN PATIENTS UNDERWENT SURGICAL AND IR INTERVENTION THE SAME DAY, RANGING FROM 58 MIN (DIRECT TRANSFER FROM THE OR) TO 7.3 H. PSEUDOANEURYSM CHARACTERISTICS: PA NUMBER PER PATIENT RANGED FROM 1 TO 5 (MULTIPLE DIFFUSE), WITH THE LARGEST MEASURING 4.3 X 3.1 CM. PAS WERE LOCATED ON THE SPLENIC ARTERY (N = 12, 34.3%), PELVIC ARTERY (INCLUDING ILIAC, FEMORAL, GLUTEAL AND PUDENDAL VESSELS) (N = 11, 31.4%), HEPATIC (N = 9, 25.7%), UPPER EXTREMITY/AXILLA (N = 2, 5.7%), AND RENAL ARTERIES (N = 1, 2.9%). PROCEDURAL OUTCOMES: TECHNICAL SUCCESS WAS 30/35 (85.7%). TWO PATIENTS WERE NOT TREATED BASED ON ANGIOGRAPHIC AND CLINICAL DATA AFTER DISCUSSION BETWEEN IR AND TRAUMA SURGEONS. THREE PATIENTS WERE NOT TREATED DUE TO LOCATION OF THE PA. ONE CASE WAS A PEDIATRIC PATIENT WITH AN AXILLARY WIDE-NECK PA PREVENTING COIL EMBOLIZATION OR STENT PLACEMENT, THE OTHER TWO WERE UNABLE TO BE TREATED DUE TO AN INABILITY TO ACCESS THE PA OR TREAT SAFELY FROM A DISTAL LOCATION WITHOUT RISK OF NON-TARGET EMBOLIZATION. OF THESE FIVE PATIENTS, FOUR UNDERWENT FOLLOW UP SURGICAL INTERVENTION WITH TREATMENT OF THE TRAUMATIC REGION AND PA. THE REMAINING 30 PATIENTS WERE TREATED WITH COILS (N = 6) ((B)(6)) OR BOTH (N = 5). THREE PATIENTS (8.6%) HAD PAS WITH ASSOCIATED ARTERIOVENOUS OR PORTAL-VENOUS FISTULAS. ALL WERE SUCCESSFULLY TREATED WITH COIL EMBOLIZATION. CLINICAL SUCCESS WAS 25/35 (71.4%). IN PATIENTS WHO WERE TREATED, SUCCESS WAS 25/30 (82.9%). IN ALL 5 CASES OF CLINICAL FAILURE, REPEAT INTERVENTIONS OCCURRED WITHIN 3 DAYS OF INITIAL TREATMENT AND WITHIN THE SAME HOSPITALIZATION. ONE PATIENT WITH AN ILIAC PA TREATED INITIALLY WITHIN 24 H OF TRAUMA WITH GELFOAM ONLY UNDERWENT REPEAT EMBOLIZATION WITH GELFOAM DUE TO PERSISTENT BLEEDING. THE REMAINING 4 CLINICAL FAILURES REQUIRED SURGICAL INTERVENTION. THREE PATIENTS UNDERWENT SPLENECTOMY FOR PERSISTENT SPLENIC PAS. TWO OF THE THREE PATIENTS WERE TREATED WITH GELFOAM ONLY WHILE THE THIRD UNDERWENT EMBOLIZATION WITH GELFOAM AND COILS. THE 4TH PATIENT HAD A GASTROEPIPLOIC PA TREATED WITH GELFOAM AS WELL. THAT PATIENT REQUIRED RE-EXPLORATION DUE TO PERSISTENT BLEEDING WITH HEMATOMA EVACUATION. THERE WAS NO PA REBLEEDING OR REINTERVENTION FOR PA TREATMENT FOR ANY PATIENT AFTER DISCHARGE OVER THE REPORTED FOLLOW-UP PERIODS. COMPLICATIONS OCCURRED IN TWO PATIENTS (5.7%). THE FIRST COMPLICATION WAS CLASSIFIED AS AN SIR MILD AE, CONSISTING OF A COMMON FEMORAL PA THAT RESOLVED WITHOUT THERAPY. THE SECOND COMPLICATION WAS CLASSIFIED AS AN SIR MODERATE AE, CONSISTING OF PEDAL PUNCTATE ARTERIAL EMBOLI THAT RESOLVED WITH A HEPARIN DRIP (MODERATE ESCALATION OF CARE), WITHOUT SEQUELAE. FIFTEEN PATIENTS (42.8%) REQUIRED RED BLOOD CELL TRANSFUSIONS POST-EMBOLIZATION, ALL OCCURRED WITHIN 5 DAYS OF IR INTERVENTION. THREE PATIENTS DIED DURING THE TRAUMA HOSPITALIZATION FOR REASONS UNRELATED TO THE PA. CAUSES OF DEATH INCLUDED (1) CEREBRAL HERNIATION LEADING TO CARDIAC ARREST, (2) ABDOMINAL COMPRESSION SYNDROME FOLLOWED BY SURGICAL EXPLORATORY LAPAROTOMY AND PROFUSE COAGULOPATHY BLEEDING FROM ABDOMINAL WALL COLLATERALS, AND (3) HYPOXEMIA FOLLOWED BY PALLIATIVE EXTUBATION PER THE PATIENT'S FAMILY'S WISHES. ALL THREE PATIENTS HAD TECHNICALLY AND CLINICALLY SUCCESSFUL TREATMENT OF THEIR PAS. DISCUSSION: HERE WE PRESENT ONE OF THE LARGEST CASE STUDIES OF ENDOVASCULAR MANAGEMENT OF TRAUMATIC PAS TO DATE, COVERING A RANGE OF PAS LOCATIONS BOTH IN THE VISCERA AND EXTREMITIES. OUR TECHNICAL SUCCESS AND CLINICAL SUCCESS RATES WERE 85.7% AND 71.4%, RESPECTIVELY, WHICH ARE SIMILAR TO THE PREVIOUSLY REPORTED MIXED ETIOLOGY/TYPE AND ORGAN-SPECIFIC SERIES IN THE LITERATURE. OUR COHORT EXPERIENCED NO SEVERE, LIFE THREATENING, OR DISABLING COMPLICATIONS OF TREATMENT AND NOR ANY SIGNIFICANT MORBIDITIES OR MORTALITIES SECONDARY TO ENDOVASCULAR TREATMENT OR PA RE-BLEEDING. IN THIS COHORT, 42.8% REQUIRED POST-IR EMBOLIZATION TRANSFUSIONS. THIS REQUIREMENT MAY BE RELATED TO BLOOD LOSS SECONDARY TO THE PA OR RELATED TO THE OVERALL TRAUMA. IN ADDITION, THREE PATIENTS WITH SPLENIC PAS REQUIRED SPLENECTOMY AFTER SUCCESSFUL IR TREATMENT OF A SPLENIC PA, HOWEVER, ALL HAD EXTENSIVE SPLENIC INJURY (GRADE GREATER OR EQUAL TO 3). ADDITIONALLY, SEVEN PATIENTS IN THIS STUDY UNDERWENT SURGICAL INTERVENTION NEAR THE SUBSEQUENTLY TREATED PA SITE, PRIOR TO IR PA EMBOLIZATION. THREE OF THESE CASES WERE PERFORMED OVER A DAY APART, POTENTIALLY CONFOUNDING THE ETIOLOGY OF TRUE TRAUMATIC PAS WITH POTENTIALLY IATROGENIC PAS. FINALLY, AS MENTIONED PREVIOUSLY, THE TRAUMA PATIENT COHORT TYPICALLY HAS SIGNIFICANT INJURIES RELATING TO THE OVERALL TRAUMA, WHICH MAY CONFOUND THE CLINICAL OUTCOMES RELATING TO PA TREATMENT IN ISOLATION. FOLLOW-UP (12JUN2021): NEW INFORMATION RECEIVED FROM PRODUCTS QUALITY COMPLAINTS INCLUDES: INVESTIGATION RESULT. INVESTIGATION RESULTS RECEIVED ON 12JUN2021: UDI WAS (B)(4). SUMMARY OF INVESTIGATION: THE SCOPE OF THIS INVESTIGATION INCLUDED A REVIEW OF COMPLAINTS FOR GELFOAM SPONGE AND POWDER RECEIVED WITHIN 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO RECEIPT OF THE REPORTED COMPLAINT. NO PREVIOUS COMPLAINTS WITH A KNOWN BATCH NUMBER WERE IDENTIFIED. NO TRENDS WERE NOTED THAT WOULD REQUIRE ADDITIONAL INVESTIGATION. NO RETURNED COMPLAINT SAMPLE WAS RECEIVED. ROOT CAUSE ANALYSIS/IDENTIF: ROOT CAUSE: ROOT CAUSE: PFIZER KALAMAZOO QUALITY OPERATIONS COULD NOT DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT TO BE RELATED TO THE KALAMAZOO PRODUCTION PROCESS. A REVIEW OF PREVIOUSLY COMPLETED INVESTIGATION REPORTS DETERMINED TO BE WITHIN SCOPE DID NOT RESULT IN IDENTIFICATION OF A BATCH NUMBER, OR A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXAMINATION OF A RETURNED COMPLAINT SAMPLE MAY HAVE AIDED IN IDENTIFICATION OF A ROOT CAUSE; HOWEVER, NONE WERE RECEIVED. IT IS UNKNOWN HOW THE REPORTED COMPLAINT SAMPLE WAS HANDLED, STORED, OR USED AFTER LEAVING THE PFIZER KALAMAZOO SITE. IMPACT ANALYSIS: QUALITY OF LOT: ACCEPTABLE. THE WORST CASE SEVERITY DETERMINED THROUGH A REVIEW OF THE DEVICE RISK FILE FOR THE PRODUCT WAS S4. 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. IMPROVE/CONTROL: CORRECTIVE / PREVENTIVE ACTION: CORRECTIONS, CORRECTIVE AND PREVENTATIVE ACTIONS: THERE WERE NO CORRECTIONS PERFORMED, OR CORRECTIVE OR PREVENTATIVE ACTIONS IDENTIFIED, AS A RESULT OF THIS COMPLAINT INVESTIGATION. INVESTIGATION OF THE COMPLAINT DID NOT DETERMINE THE REPORTED ISSUE TO BE PROCESS RELATED; THEREFORE, A CORRECTION, OR CORRECTIVE OR PREVENTATIVE ACTION, IS NOT REQUIRED FOR THIS CASE. ADDITIONALLY, A REVIEW OF 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 COMPLAINT FOR PERFORMANCE NOT AS INDICATED IN LABEL FOR AN UNKNOWN BATCH OF GELFOAM SPONGE WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. MANUFACTURING/PACKAGING RECORDS: COMPLETE - ACCEPTABLE A REVIEW OF MANUFACTURING AND PACKAGING RECORDS COULD NOT BE PERFORMED FOR THE COMPLAINT, AS THE COMPLAINT IS FOR AN UNKNOWN BATCH. ADDITIONALLY, A REVIEW OF BATCH RECORDS FROM THE PREVIOUSLY INVESTIGATED COMPLAINTS DETERMINED TO BE IN SCOPE COULD NOT BE PERFORMED, AS THERE WERE NO COMPLAINTS WITH A KNOWN BATCH.GELFOAM POWDER IS MANUFACTURED FROM SOLID SPONGE BRICKS. THE BULK MANUFACTURED SOLUTION IS FORCED THROUGH A FILTER WITH NITROGEN TO EXTRUDE THE LARGE, SOLID SPONGE BRICKS. THE BRICKS ARE DRIED, TRIMMED AND SPLIT. THE SPLIT BRICKS ARE THEN MILLED TO FORM POWDER. THE POWDER IS COLLECTED IN HIGH DENSITY POLYETHYLENE BAGS AND THEN SEALED INTO BULK CONTAINERS. THE GELFOAM POWDER IS THEN FILLED INTO INNER ENVELOPES USING A POWDER FILLING DEVICE. EACH ENVELOPE IS FILLED WITH A TARGET OF 1.2 GRAMS PER ENVELOPE AND A MINIMUM OF 1.0 GRAM PER ENVELOPE. TWO WEIGHT CHECKS OF EACH POWDER FILLING DEVICE ARE CONDUCTED AT 30 MINUTE INTERVALS TO ASSURE THAT THE DEVICE IS DISPENSING THE PROPER AMOUNT OF POWDER. THE FINAL PRODUCT YIELD IS CALCULATED AGAINST LIMITS FOR THE PRODUCT. THE INNER ENVELOPES ARE FOLDED OVER TWICE AND INSERTED INTO SLEEVES. THE FILLED SLEEVES ARE PLACED INTO TRAYS. THE SLEEVES (PEEL POUCHES) ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE ENVELOPES HAVE THE PROPER APPEARANCE, SEAL AND PRINT, AND ALL NOTED DEFECTIVE PRODUCT IS REMOVED FROM THE LOT PRIOR TO FINAL PACKAGING AND NO OPEN SIDE SEALS WERE OBSERVED. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON. FOR GELFOAM SPONGE, THE BILL OF MATERIALS LISTS THE SPECIFIC PRODUCT COMPONENTS AND WEIGHTS REQUIRED FOR THE FORMULATION OF EACH BATCH. ALL MANUFACTURING MIXING SPEEDS, TIMES, AND TEMPERATURES HAVE SPECIFICATION CRITERIA. ALL EXTRUSION PARAMETERS HAVE REQUIRED SPECIFICATIONS. AFTER THE PRODUCT IS EXTRUDED INTO BRICKS, THE BRICKS ARE INSPECTED PRIOR TO BEING SLICED INTO INDIVIDUAL SPONGES. AFTER THE BRICKS ARE SLICED INTO SPONGES, A VISUAL INSPECTION IS PERFORMED FOR CONSISTENCY, UNIFORMITY, SHAPE, AND SIZE AT THE BEGINNING, MIDDLE, AND END OF SHIFTS AND EVERY FOUR HOURS IN BETWEEN. ALL DEFECTIVE SPONGES ARE IDENTIFIED AND REMOVED. THE GELFOAM IS PLACED INTO INNER ENVELOPES, AND TRANSFERRED TO THE DOYEN PACKAGING EQUIPMENT TO PACKAGE THE ENVELOPES INTO PEEL POUCHES. THE DOYEN TAKES SIX ENVELOPES PER ROTATION BY SUCTION AND LOADS THEM ONTO A CONVEYER BELT AGAINST AN ALIGNMENT TAB. TWO OPERATORS SIT AT THE DOYEN TO CORRECT ALIGNMENT ISSUES PRIOR TO SEALING. THE FRONT AND BACK PAPERS, WHICH MAKE UP THE OUTER PEEL POUCH, ENCLOSE EACH INDIVIDUAL INNER ENVELOPE ENTIRELY WITH A FOUR-SIDED, HEAT-ACTIVATED ADHESIVE SEAL. THE TOP, BOTTOM, AND SIDES OF THE OUTER PEEL POUCHES ARE SEALED BY THREE DIFFERENT PARTS OF THE DOYEN WHICH EACH HAVE SEPARATE TEMPERATURE CONTROLS. EACH TEMPERATURE CONTROL IS VERIFIED AND DOCUMENTED IN THE BATCH RECORD.THE PEEL POUCHES ARE SEALED AND HEAT STERILIZED. SEALED AND STERILIZED GELFOAM PEEL POUCHES ARE 100% VISUALLY INSPECTED BY TRAINED PACKAGING OPERATORS PRIOR TO FINAL PACKAGING. THE PURPOSE OF THIS INSPECTION IS TO ENSURE THAT THE PEEL POUCHES HAVE THE PROPER APPEARANCE, SEAL AND PRINT. A SEAL INTEGRITY TEST (SIT) IS UTILIZED THROUGHOUT THE FINAL PACKAGING TO ENSURE THE SIDE SEALS OF THE PEEL POUCHES ARE ACCEPTABLE. THE STERILIZED PEEL POUCHES ARE PACKAGED INTO EACH FINAL GOODS CARTON.AUDITS ARE PERFORMED ON THE FINISHED PACKAGED UNITS AT REGULAR INTERVALS THROUGHOUT THE FINAL PACKAGING PROCESS. PROCESS CONTROL EVALUATION: EXISTING PROCESS CONTROLS WERE REVIEWED AS A PART OF THIS INVESTIGATION. THE REVIEW DETERMINED THAT THE PROCESS CONTROLS WERE APPROPRIATE AND ACCEPTABLE; THEREFORE THE MEDICAL DEVICE QOP WAS NOT NOTIFIED. QO BATCH HISTORY REPORT: A REVIEW OF RELEASE TESTING RESULTS COULD NOT BE PERFORMED AS THE REPORTED COMPLAINT BATCH IS UNKNOWN. 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 PRODUCT USE ATTRIBUTES. THERE WAS ONE MONTHS ((B)(6) 2021) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (7). A REVIEW OF THE 7 COMPLAINTS RECEIVED IN (B)(6) 2021 DETERMINED THAT ALL PERTAIN TO REVIEW OF A SINGLE LITERATURE ARTICLE, AND THE INVESTIGATIONS ARE IN PROGRESS, INCLUDING THE INVESTIGATION DOCUMENTED IN THIS RECORD. HOWEVER, THIS WAS DUE A REMEDIATION EFFORT BY PFIZER US SAFETY. ADDITIONALLY, THE RESULTS FROM THE QUERY WERE EVALUATED BY THE SUB-CLASSES OF LACK OF EFFECT AND 'PERFORMANCE NOT AS INDICATED IN LABEL TO REFLECT HISTORICAL CLASSIFICATIONS, AND THERE WERE TWO MONTHS ((B)(6)AND (B)(6) 2020) THAT INCLUDED A HIGHER THAN NORMAL NUMBER OF COMPLAINTS (4 RECEIVED EACH MONTH, RESPECTIVELY). A REVIEW OF THE 8 COMPLAINTS RECEIVED DETERMINED THAT EACH WAS FOR AN UNKNOWN BATCH NUMBER, AND NONE WERE CONFIRMED OR PROCESS RELATED. NO TREND WAS OBSERVED THAT WOULD REQUIRE FURTHER INVESTIGATION. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THIS CASE IS OF CLINICAL FAILURE (RE-BLEEDING/RE-INTERVENTION REQUIRED). AFTER EMBOLIZATION PROCEDURE, THIS PATIENT REQUIRED A SPLENECTOMY FOR PERSISTENT SPLENIC PSEUDOANEURYSMS AFTER GELFOAM USE. DUE TO A PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DRUG SAFETY PROFILE, A CAUSAL ASSOCIATION CANNOT BE EXCLUDED FOR THE REPORTED EVENTS. CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER DRUG 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 THE INFORMATION PROVIDED, THIS CASE IS OF CLINICAL FAILURE (RE-BLEEDING/RE-INTERVENTION REQUIRED). AFTER EMBOLIZATION PROCEDURE, THIS PATIENT REQUIRED A SPLENECTOMY FOR PERSISTENT SPLENIC PSEUDOANEURYSMS AFTER GELFOAM USE. DUE TO A PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DRUG SAFETY PROFILE, A CAUSAL ASSOCIATION CANNOT BE EXCLUDED FOR THE REPORTED EVENTS. CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER DRUG 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.
GELFOAM FOR TRAUMATIC PSEUDOANEURYSM [OFF LABEL USE], CLINICAL FAILURE/PERSISTENT SPLENIC PA [THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION], NARRATIVE: THIS IS A LITERATURE REPORT FROM CVIR ENDOVASCULAR, 2020, VOL 3 (1); DOI: 10.1186/S42155-020-00182-7, ENTITLED "ENDOVASCULAR MANAGEMENT OF TRAUMATIC PSEUDOANEURYSMS". THE AUTHOR REPORTED SIMILAR EVENTS FOR 5 PATIENTS. THIS IS THE 4TH OF 5 REPORTS (PATIENT OF UNSPECIFIED AGE AND GENDER WHO EXPERIENCED CLINICAL FAILURE AND UNDERWENT SPLENECTOMY FOR PERSISTENT SPLENIC PAS). METHODS: CLINICAL DATA WERE RETROSPECTIVELY COLLECTED FROM ALL PATIENTS PRESENTING FOR TREATMENT OF PAS BETWEEN SEPTEMBER 2012 AND SEPTEMBER 2018 AT A SINGLE ACADEMIC LEVEL ONE TRAUMA CENTER. INCLUSION CRITERIA WERE PATIENTS WHO HAD SUSTAINED TRAUMA, WHO HAD PA(S), AND WERE TREATED BY ENDOVASCULAR APPROACH WITH INTERVENTIONAL RADIOLOGY (IR). EXCLUSION CRITERIA WERE PA(S) OF NON-TRAUMATIC ORIGIN, CONTRAST EXTRAVASATION ON CT/ANGIOGRAM WITHOUT A DEFINED PSEUDOANEURYSM, DIFFUSE PA(S) IN THE HEAD/NECK OR CORONARY VESSELS, PARENCHYMAL HEMORRHAGE, OR LACERATION, AS DEFINED BY ZARZAUR ET AL. (ZARZAUR ET AL. 2017). PAS IDENTIFIED OR TREATED OVER 3 MONTHS AFTER TRAUMA WERE ALSO EXCLUDED TO BEST ENSURE A TRAUMATIC ETIOLOGY. PATIENT RECORDS WERE REVIEWED FOR DEMOGRAPHIC INFORMATION, TRAUMA TYPE (BLUNT VS. PENETRATING), TRANSFUSION REQUIREMENTS PRE- AND POSTTREATMENT, PA(S) LOCATION, PROCEDURAL TECHNIQUE, ADDITIONAL INTERVENTIONS, AND CLINICAL OUTCOMES, INCLUDING: LENGTH OF HOSPITALIZATION, ICU REQUIREMENTS, MORBIDITY, AND MORTALITY. ALL AVAILABLE PATIENT DATA WERE UTILIZED FOR THE FOLLOW-UP PERIOD. PROCEDURAL TECHNIQUE: ALL PATIENTS PRESENTING FOR TRAUMA (BLUNT OR LOCALIZED) UNDERWENT PRIMARY ASSESSMENT FOLLOWED BY CONTRAST ENHANCED COMPUTED TOMOGRAPHY (CT) FOR VASCULAR EVALUATION. IMAGING INDICATIVE OR SUSPICIOUS FOR ARTERIAL DISRUPTION WAS REFERRED TO IR FOR INTERVENTION. ALL ENDOVASCULAR INTERVENTIONS WERE PERFORMED BY INTERVENTIONAL RADIOLOGISTS IN DEDICATED ENDOVASCULAR SUITES. INFORMED OR EMERGENCY CONSENT WAS OBTAINED AND SEDATION WAS PROVIDED BASED ON INDIVIDUAL PATIENT ASSESSMENT AND NEEDS, RANGING FROM MODERATE SEDATION TO GENERAL ANESTHESIA. ALL PATIENTS WERE PLACED SUPINE, WITH BOTH GROINS PREPPED AND DRAPED. PERCUTANEOUS ACCESS WAS OBTAINED UNDER ULTRASOUND GUIDANCE USING A STANDARD MICROPUNCTURE SET. SELDINGER TECHNIQUE WAS USED TO UPSIZE AND A 5 FRENCH (FR) VASCULAR SHEATH WAS INSERTED IN THE RIGHT OR LEFT COMMON FEMORAL ARTERIES. A STANDARD 5 FR CATHETER (E.G. COBRA 2 (MERIT MEDICAL, SALT LAKE CITY, UT, USA), ROBERTS UTERINE CATHETER (RUC) (COOK, BLOOMINGTON, IN, USA) OR SOS (ANGIODYNAMICS, LATHAM, NY, USA)) DEPENDING ON PATIENT ANATOMY AND PA LOCATION WAS SUBSEQUENTLY USED TO SELECTIVELY CATHETERIZE THE CULPRIT ARTERY ACCORDING TO CTA IMAGING AND ANGIOGRAPHY WAS THEN PERFORMED. COAXIAL TECHNIQUE WITH A MICROCATHETER WAS USED TO SUBSELECTIVELY CATHETERIZE THE PA ARTERY. TREATMENT WAS THEN PERFORMED WITH GELFOAM SLURRY (PFIZER, NEW YORK, NY, USA), COIL EMBOLIZATION, OR BOTH. FOLLOWING TREATMENT, POST-EMBOLIZATION ANGIOGRAPHY WAS PERFORMED. AT THE COMPLETION OF THE PROCEDURE, THE 5 FR CATHETER AND FEMORAL VASCULAR SHEATH WERE REMOVED AND HEMOSTASIS OBTAINED VIA A CLOSURE DEVICE OR MANUAL PRESSURE. STERILE DRESSING WAS APPLIED. TECHNICAL SUCCESS WAS DEFINED AS SUCCESSFUL TREATMENT OF THE PA WITH NO RESIDUAL FILLING ON POST-EMBOLIZATION ANGIOGRAM. CLINICAL SUCCESS WAS DEFINED AS TECHNICALLY SUCCESSFUL TREATMENT WITH NO REBLEEDING THROUGHOUT THE FOLLOW-UP PERIOD AND NO REINTERVENTION FOR THE PA. RESULTS: PATIENT CHARACTERISTICS: ONE HUNDRED FOUR PATIENTS WERE TREATED WITH INTERVENTIONAL RADIOLOGY (IR) BY ENDOVASCULAR MANAGEMENT FOR PAS OVER THE SIX-YEAR STUDY PERIOD. THIRTY-FIVE PATIENTS FULFILLED THE INCLUSION/EXCLUSION CRITERIA, WITH THE MAJORITY EXCLUDED FOR PAS OF NON-TRAUMATIC ETIOLOGY (E.G. PANCREATITIS, MALIGNANCY, OR IATROGENIC). FOLLOW-UP DATA AFTER TRAUMA HOSPITALIZATION RANGED FROM 0 DAYS-4.4 YRS. (MEDIAN: 44 DAYS; IQR: 2.3-205.5 DAYS). ALL 35 PATIENTS (10F/25M), AVERAGE AGE (+-STDEV) 41.7 +-20.1 YEARS, PRESENTING WITH BLUNT (N = 31) OR PENETRATING (N = 4) TRAUMA, UNDERWENT ENDOVASCULAR TREATMENT WITH IR. TIME FROM TRAUMA TO IR INTERVENTION RANGED FROM 2 H - 75 DAYS (MEDIAN: 4.4 H, IQR: 3.5-17.1 H) WITH 27 (77%) OF PAS IDENTIFIED AND TREATED WITHIN 24 H OF TRAUMA. AVERAGE HOSPITALIZATION WAS 13.78 +-13.4 DAYS. AVERAGE ICU STAY WAS 9.2 +-10.11 DAYS. TEN PATIENTS UNDERWENT A SURGICAL PROCEDURE PRIOR TO IR INTERVENTION. SEVEN OF THE SURGICAL TREATMENTS WERE PERFORMED NEAR THE SITE OF PA LOCATION. FOUR PATIENTS UNDERWENT ABDOMINAL EXPLORATORY LAPAROTOMY, FOLLOWED BY TREATMENT OF LIVER OR GASTROEPIPLOIC PAS. THREE PATIENTS UNDERWENT PELVIC EXPLORATION OR ORTHOPEDIC PELVIC/ FEMUR FRACTURE REPAIR AND WERE SUBSEQUENTLY TREATED FOR ILIAC OR FEMORAL PAS. FOUR OF SEVEN PATIENTS UNDERWENT SURGICAL AND IR INTERVENTION THE SAME DAY, RANGING FROM 58 MIN (DIRECT TRANSFER FROM THE OR) TO 7.3 H. PSEUDOANEURYSM CHARACTERISTICS: PA NUMBER PER PATIENT RANGED FROM 1 TO 5 (MULTIPLE DIFFUSE), WITH THE LARGEST MEASURING 4.3 X 3.1 CM. PAS WERE LOCATED ON THE SPLENIC ARTERY (N = 12, 34.3%), PELVIC ARTERY (INCLUDING ILIAC, FEMORAL, GLUTEAL AND PUDENDAL VESSELS) (N = 11, 31.4%), HEPATIC (N = 9, 25.7%), UPPER EXTREMITY/AXILLA (N = 2, 5.7%), AND RENAL ARTERIES (N = 1, 2.9%). PROCEDURAL OUTCOMES: TECHNICAL SUCCESS WAS 30/35 (85.7%). TWO PATIENTS WERE NOT TREATED BASED ON ANGIOGRAPHIC AND CLINICAL DATA AFTER DISCUSSION BETWEEN IR AND TRAUMA SURGEONS. THREE PATIENTS WERE NOT TREATED DUE TO LOCATION OF THE PA. ONE CASE WAS A PEDIATRIC PATIENT WITH AN AXILLARY WIDE-NECK PA PREVENTING COIL EMBOLIZATION OR STENT PLACEMENT, THE OTHER TWO WERE UNABLE TO BE TREATED DUE TO AN INABILITY TO ACCESS THE PA OR TREAT SAFELY FROM A DISTAL LOCATION WITHOUT RISK OF NON-TARGET EMBOLIZATION. OF THESE FIVE PATIENTS, FOUR UNDERWENT FOLLOW UP SURGICAL INTERVENTION WITH TREATMENT OF THE TRAUMATIC REGION AND PA. THE REMAINING 30 PATIENTS WERE TREATED WITH COILS (N = 6) (AZUR COILS: TERUMO, SHIBYA, TOKYO, JAPAN; TORNADO COILS: COOK MEDICAL, BLOOMINGTON, IN, USA; NESTER COILS: COOK MEDICAL, BLOOMINGTON, IN, USA; CONCERTO COILS: MEDTRONIC, MINNEAPOLIS, MN, USA), GELFOAM SLURRY (N = 19) (PFIZER, NEW YORK, NY, USA) OR BOTH (N = 5). THREE PATIENTS (8.6%) HAD PAS WITH ASSOCIATED ARTERIOVENOUS OR PORTAL-VENOUS FISTULAS. ALL WERE SUCCESSFULLY TREATED WITH COIL EMBOLIZATION. CLINICAL SUCCESS WAS 25/35 (71.4%). IN PATIENTS WHO WERE TREATED, SUCCESS WAS 25/30 (82.9%). IN ALL 5 CASES OF CLINICAL FAILURE, REPEAT INTERVENTIONS OCCURRED WITHIN 3 DAYS OF INITIAL TREATMENT AND WITHIN THE SAME HOSPITALIZATION. ONE PATIENT WITH AN ILIAC PA TREATED INITIALLY WITHIN 24 H OF TRAUMA WITH GELFOAM ONLY UNDERWENT REPEAT EMBOLIZATION WITH GELFOAM DUE TO PERSISTENT BLEEDING. THE REMAINING 4 CLINICAL FAILURES REQUIRED SURGICAL INTERVENTION. THREE PATIENTS UNDERWENT SPLENECTOMY FOR PERSISTENT SPLENIC PAS. TWO OF THE THREE PATIENTS WERE TREATED WITH GELFOAM ONLY WHILE THE THIRD UNDERWENT EMBOLIZATION WITH GELFOAM AND COILS. THE 4TH PATIENT HAD A GASTROEPIPLOIC PA TREATED WITH GELFOAM AS WELL. THAT PATIENT REQUIRED RE-EXPLORATION DUE TO PERSISTENT BLEEDING WITH HEMATOMA EVACUATION. THERE WAS NO PA REBLEEDING OR REINTERVENTION FOR PA TREATMENT FOR ANY PATIENT AFTER DISCHARGE OVER THE REPORTED FOLLOW-UP PERIODS. COMPLICATIONS OCCURRED IN TWO PATIENTS (5.7%). THE FIRST COMPLICATION WAS CLASSIFIED AS AN SIR MILD AE, CONSISTING OF A COMMON FEMORAL PA THAT RESOLVED WITHOUT THERAPY. THE SECOND COMPLICATION WAS CLASSIFIED AS AN SIR MODERATE AE, CONSISTING OF PEDAL PUNCTATE ARTERIAL EMBOLI THAT RESOLVED WITH A HEPARIN DRIP (MODERATE ESCALATION OF CARE), WITHOUT SEQUELAE. FIFTEEN PATIENTS (42.8%) REQUIRED RED BLOOD CELL TRANSFUSIONS POST-EMBOLIZATION, ALL OCCURRED WITHIN 5 DAYS OF IR INTERVENTION. THREE PATIENTS DIED DURING THE TRAUMA HOSPITALIZATION FOR REASONS UNRELATED TO THE PA. CAUSES OF DEATH INCLUDED (1) CEREBRAL HERNIATION LEADING TO CARDIAC ARREST, (2) ABDOMINAL COMPRESSION SYNDROME FOLLOWED BY SURGICAL EXPLORATORY LAPAROTOMY AND PROFUSE COAGULOPATHY BLEEDING FROM ABDOMINAL WALL COLLATERALS, AND (3) HYPOXEMIA FOLLOWED BY PALLIATIVE EXTUBATION PER THE PATIENT'S FAMILY'S WISHES. ALL THREE PATIENTS HAD TECHNICALLY AND CLINICALLY SUCCESSFUL TREATMENT OF THEIR PAS. DISCUSSION: HERE WE PRESENT ONE OF THE LARGEST CASE STUDIES OF ENDOVASCULAR MANAGEMENT OF TRAUMATIC PAS TO DATE, COVERING A RANGE OF PAS LOCATIONS BOTH IN THE VISCERA AND EXTREMITIES. OUR TECHNICAL SUCCESS AND CLINICAL SUCCESS RATES WERE 85.7% AND 71.4%, RESPECTIVELY, WHICH ARE SIMILAR TO THE PREVIOUSLY REPORTED MIXED ETIOLOGY/TYPE AND ORGAN-SPECIFIC SERIES IN THE LITERATURE. OUR COHORT EXPERIENCED NO SEVERE, LIFE THREATENING, OR DISABLING COMPLICATIONS OF TREATMENT AND NOR ANY SIGNIFICANT MORBIDITIES OR MORTALITIES SECONDARY TO ENDOVASCULAR TREATMENT OR PA RE-BLEEDING. IN THIS COHORT, 42.8% REQUIRED POST-IR EMBOLIZATION TRANSFUSIONS. THIS REQUIREMENT MAY BE RELATED TO BLOOD LOSS SECONDARY TO THE PA OR RELATED TO THE OVERALL TRAUMA. IN ADDITION, THREE PATIENTS WITH SPLENIC PAS REQUIRED SPLENECTOMY AFTER SUCCESSFUL IR TREATMENT OF A SPLENIC PA, HOWEVER, ALL HAD EXTENSIVE SPLENIC INJURY (GRADE GREATER OR EQUAL TO 3). ADDITIONALLY, SEVEN PATIENTS IN THIS STUDY UNDERWENT SURGICAL INTERVENTION NEAR THE SUBSEQUENTLY TREATED PA SITE, PRIOR TO IR PA EMBOLIZATION. THREE OF THESE CASES WERE PERFORMED OVER A DAY APART, POTENTIALLY CONFOUNDING THE ETIOLOGY OF TRUE TRAUMATIC PAS WITH POTENTIALLY IATROGENIC PAS. FINALLY, AS MENTIONED PREVIOUSLY, THE TRAUMA PATIENT COHORT TYPICALLY HAS SIGNIFICANT INJURIES RELATING TO THE OVERALL TRAUMA, WHICH MAY CONFOUND THE CLINICAL OUTCOMES RELATING TO PA TREATMENT IN ISOLATION. COMPANY CLINICAL EVALUATION COMMENT: BASED ON THE INFORMATION PROVIDED, THIS CASE IS OF CLINICAL FAILURE (RE-BLEEDING/RE-INTERVENTION REQUIRED). AFTER EMBOLIZATION PROCEDURE, THIS PATIENT REQUIRED A SPLENECTOMY FOR PERSISTENT SPLENIC PSEUDOANEURYSMS AFTER GELFOAM USE. DUE TO A PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DRUG SAFETY PROFILE, A CAUSAL ASSOCIATION CANNOT BE EXCLUDED FOR THE REPORTED EVENTS. CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER DRUG 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE., COMMENT: BASED ON THE INFORMATION PROVIDED, THIS CASE IS OF CLINICAL FAILURE (RE-BLEEDING/RE-INTERVENTION REQUIRED). AFTER EMBOLIZATION PROCEDURE, THIS PATIENT REQUIRED A SPLENECTOMY FOR PERSISTENT SPLENIC PSEUDOANEURYSMS AFTER GELFOAM USE. DUE TO A PLAUSIBLE TEMPORAL ASSOCIATION AND KNOWN DRUG SAFETY PROFILE, A CAUSAL ASSOCIATION CANNOT BE EXCLUDED FOR THE REPORTED EVENTS. CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER DRUG 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 |
|---|---|---|---|---|---|---|---|
| 705238 | GELFOAM | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. (DEVICE) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |