ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2025-00025
- Event Type
- Injury
- Date Received
- October 15, 2025
- Report Date
- October 6, 2025
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION SUMMARY AND CONCLUSION: DEI CONCLUSION. THIS RECORD SHOULD BE CANCELLED BECAUSE THE PRODUCT IS OUT OF SCOPE FOR DEVICE ENGINEERING INVESTIGATIONS. NO FURTHER MANUFACTURING INVESTIGATION WAS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE WAS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED.
INVESTIGATION SUMMARY AND CONCLUSION: DEI CONCLUSION. THIS RECORD SHOULD BE CANCELLED BECAUSE THE PRODUCT IS OUT OF SCOPE FOR DEVICE ENGINEERING INVESTIGATIONS. NO FURTHER MANUFACTURING INVESTIGATION WAS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE WAS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED.
INVESTIGATION SUMMARY AND CONCLUSION: DEI CONCLUSION. THIS RECORD SHOULD BE CANCELLED BECAUSE THE PRODUCT IS OUT OF SCOPE FOR DEVICE ENGINEERING INVESTIGATIONS. NO FURTHER MANUFACTURING INVESTIGATION WAS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE WAS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED.
EVENT VERBATIM [PREFERRED TERM] EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED [OFF LABEL USE], EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED [DEVICE USE ISSUE], POST-EMBOLIZATION SYNDROME [POST EMBOLISATION SYNDROME], PYREXIA [PYREXIA], RIGHT CHEST PAIN APPEARED [CHEST PAIN], SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED [THERAPEUTIC RESPONSE UNEXPECTED], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED AFTER PREOPERATIVE EMBOLIZATION", JOURNAL OF THE EASTERN JAPAN ASSOCIATION OF ORTHOPEDICS AND TRAUMATOLOGY, 2025; VOL:37(3), PGS:314. A 53-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "THORACIC SPINAL CORD DUMBBELL TUMOUR" (ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED"; POST EMBOLISATION SYNDROME (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "POST-EMBOLIZATION SYNDROME"; PYREXIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING"; CHEST PAIN (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING", DESCRIBED AS "RIGHT CHEST PAIN APPEARED"; THERAPEUTIC RESPONSE UNEXPECTED (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BLOOD TEST: THERE WAS NO OBVIOUS SOURCE OF HEAT; BODY TEMPERATURE: EXCEEDING 38; COMPUTERISED TOMOGRAM: SHOWED CLEAR ARTERIAL SUPPLY AROUND THE TUMOUR; SHOWED A MASS IN THE PARAVERTEBRAL BODY; IMAGING PROCEDURE: THERE WAS NO OBVIOUS SOURCE OF HEAT; WORKPLACE HEALTH CHECKUP: AN ABNORMAL SHADOW ON THE CHEST; MAGNETIC RESONANCE IMAGING: SHOWED A 43 MM X 50 MM TUMOUR, NOTES: EXTENDING FROM THE T9/10 RIGHT INTERVERTEBRAL FORAMEN INTO THE THORACIC CAVITY; NEUROLOGICAL EXAMINATION: NO NEUROLOGICAL FINDINGS ABNORMAL. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. CLINICAL COURSE: PREOPERATIVE EMBOLIZATION OF SPINAL TUMOURS IS WIDELY USED IN BONE TUMOURS AND METASTATIC TUMOURS TO SUPPRESS THE VOLUME OF OPERATIVE HAEMORRHAGE. IN CONTRAST, COMPLICATIONS SUCH AS SKIN NECROSIS AND TRANSIENT PARALYSIS HAVE ALSO BEEN REPORTED FOR EMBOLIZATION. THE AUTHOR REPORTED THEIR EXPERIENCE WITH A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TRANSIENTLY IMPROVED BY PREOPERATIVE EMBOLIZATION. A 53-YEAR-OLD MAN. DURING A WORKPLACE HEALTH CHECKUP, AN ABNORMAL SHADOW ON THE CHEST WAS POINTED OUT, AND THE PATIENT VISITED A LOCAL DOCTOR IN YEAR X-3. A CT SHOWED A MASS IN THE PARAVERTEBRAL BODY; THUS, THE PATIENT WAS REFERRED TO THE HOSPITAL. AT THE TIME OF THE INITIAL VISIT, THE PATIENT HAD PAIN ONLY IN THE RIGHT T10 REGION, AND NO NEUROLOGICAL FINDINGS ABNORMAL WERE OBSERVED. AN MRI SHOWED A 43 MM X 50 MM TUMOUR EXTENDING FROM THE T9/10 RIGHT INTERVERTEBRAL FORAMEN INTO THE THORACIC CAVITY, AND A DIAGNOSIS OF A DUMBBELL TUMOUR WAS MADE. SYMPTOMS WERE ALSO MINIMAL; THUS, THE PATIENT WAS SCHEDULED TO BE FOLLOWED UP. HOWEVER, AT THE TIME OF THE VISIT FOR MONTH X-2, NUMBNESS IN BOTH LOWER EXTREMITIES, ILIOPSOAS MUSCLE WEAKNESS, AND GAIT SPASTIC APPEARED, AND THE SPINAL CORD SYMPTOMS WORSENED; THUS, THE PATIENT WAS SCHEDULED TO UNDERGO SURGERY AND TREATMENT. A CONTRAST-ENHANCED CT SHOWED CLEAR ARTERIAL SUPPLY AROUND THE TUMOUR; THUS, EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED THE DAY BEFORE SURGERY. SINCE THE DAY AFTER SURGERY, PYREXIA EXCEEDING 38°C AND RIGHT CHEST PAIN APPEARED, THE SURGERY SCHEDULED WAS POSTPONED. ALTHOUGH BLOOD DRAWS AND IMAGING TESTS WERE PERFORMED, THERE WAS NO OBVIOUS SOURCE OF HEAT, AND PYREXIA AND CHEST PAIN WERE ALSO ALLEVIATED ON DAY 5 AFTER EMBOLIZATION. THUS, SYMPTOMS DUE TO POST-EMBOLIZATION SYNDROME WERE SUSPECTED BASED ON THE CLINICAL COURSE. WHEN NEUROLOGICAL SYMPTOMS WERE CONFIRMED AGAIN ON DAY 7 OF EMBOLIZATION, GAIT SPASTIC IMPROVED, AND AN MRI PERFORMED 4 WEEKS AFTER EMBOLIZATION SHOWED AN INCREASE IN FLUID COMPONENTS INSIDE THE TUMOUR. SINCE THE GENERAL CONDITION HAD ALSO IMPROVED, TUMOURECTOMY WAS PERFORMED 6 WEEKS LATER. THE AUTHOR EXPERIENCED A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED AFTER EMBOLIZATION. SINCE SURGERY WAS INCIDENTALLY POSTPONED DUE TO POST-EMBOLIZATION SYNDROME, IT WAS POSSIBLE TO EVALUATE THE EFFECT OF EMBOLIZATION. IT IS THOUGHT THAT TISSUE NECROSIS CAUSED BY EMBOLIZATION LED TO A DECREASE IN THE INTERNAL PRESSURE, THEREBY DECREASING THE DEGREE OF SPINAL CORD COMPRESSION. FURTHER STUDIES ARE NEEDED ON THE COMPLICATIONS AND EFFECTS OF EMBOLIZATION. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 16OCT2025 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: DEI CONCLUSION. THIS RECORD SHOULD BE CANCELLED BECAUSE THE PRODUCT IS OUT OF SCOPE FOR DEVICE ENGINEERING INVESTIGATIONS. NO FURTHER MANUFACTURING INVESTIGATION WAS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE WAS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6) 2025 FOR ABSORBABLE GELATIN: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS 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. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY.ADDITIONAL PRODUCT QUALITY INFORMATION: "INVESTIGATION SUMMARY AND CONCLUSION: DEI CONCLUSION. THIS RECORD SHOULD BE CANCELLED BECAUSE THE PRODUCT IS OUT OF SCOPE FOR DEVICE ENGINEERING INVESTIGATIONS. NO FURTHER MANUFACTURING INVESTIGATION WAS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE WAS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED." CAUSALITY FOR "EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED", "POST-EMBOLIZATION SYNDROME", "PYREXIA", "RIGHT CHEST PAIN APPEARED" AND "SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (16OCT2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. FOLLOW-UP (06NOV2025): THIS IS A LITERATURE SPONTANEOUS FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. UPDATED INFORMATION: DEVICE PROBLEM CODE ADDED. FOLLOW-UP (19DEC2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: THERE IS A REASONABLE POSSIBILITY THAT THE EVENTS WERE RELATED TO ABSORBABLE GELATIN BASED ON THE TEMPORAL ASSOCIATION.
EVENT VERBATIM [PREFERRED TERM] EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED [OFF LABEL USE], EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED [DEVICE USE ISSUE], POST-EMBOLIZATION SYNDROME [POST EMBOLISATION SYNDROME], PYREXIA [PYREXIA], RIGHT CHEST PAIN APPEARED [CHEST PAIN], SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED [THERAPEUTIC RESPONSE UNEXPECTED], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED AFTER PREOPERATIVE EMBOLIZATION", JOURNAL OF THE EASTERN JAPAN ASSOCIATION OF ORTHOPEDICS AND TRAUMATOLOGY, 2025; VOL:37(3), PGS:314. A 53-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "THORACIC SPINAL CORD DUMBBELL TUMOUR" (ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED"; POST EMBOLISATION SYNDROME (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "POST-EMBOLIZATION SYNDROME"; PYREXIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING"; CHEST PAIN (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING", DESCRIBED AS "RIGHT CHEST PAIN APPEARED"; THERAPEUTIC RESPONSE UNEXPECTED (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BLOOD TEST: THERE WAS NO OBVIOUS SOURCE OF HEAT; BODY TEMPERATURE: EXCEEDING 38; COMPUTERISED TOMOGRAM: SHOWED CLEAR ARTERIAL SUPPLY AROUND THE TUMOUR; SHOWED A MASS IN THE PARAVERTEBRAL BODY; IMAGING PROCEDURE: THERE WAS NO OBVIOUS SOURCE OF HEAT; WORKPLACE HEALTH CHECKUP: AN ABNORMAL SHADOW ON THE CHEST; MAGNETIC RESONANCE IMAGING: SHOWED A 43 MM X 50 MM TUMOUR, NOTES: EXTENDING FROM THE T9/10 RIGHT INTERVERTEBRAL FORAMEN INTO THE THORACIC CAVITY; NEUROLOGICAL EXAMINATION: NO NEUROLOGICAL FINDINGS ABNORMAL. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. CLINICAL COURSE: PREOPERATIVE EMBOLIZATION OF SPINAL TUMOURS IS WIDELY USED IN BONE TUMOURS AND METASTATIC TUMOURS TO SUPPRESS THE VOLUME OF OPERATIVE HAEMORRHAGE. IN CONTRAST, COMPLICATIONS SUCH AS SKIN NECROSIS AND TRANSIENT PARALYSIS HAVE ALSO BEEN REPORTED FOR EMBOLIZATION. THE AUTHOR REPORTED THEIR EXPERIENCE WITH A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TRANSIENTLY IMPROVED BY PREOPERATIVE EMBOLIZATION. A 53-YEAR-OLD MAN. DURING A WORKPLACE HEALTH CHECKUP, AN ABNORMAL SHADOW ON THE CHEST WAS POINTED OUT, AND THE PATIENT VISITED A LOCAL DOCTOR IN YEAR X-3. A CT SHOWED A MASS IN THE PARAVERTEBRAL BODY; THUS, THE PATIENT WAS REFERRED TO THE HOSPITAL. AT THE TIME OF THE INITIAL VISIT, THE PATIENT HAD PAIN ONLY IN THE RIGHT T10 REGION, AND NO NEUROLOGICAL FINDINGS ABNORMAL WERE OBSERVED. AN MRI SHOWED A 43 MM X 50 MM TUMOUR EXTENDING FROM THE T9/10 RIGHT INTERVERTEBRAL FORAMEN INTO THE THORACIC CAVITY, AND A DIAGNOSIS OF A DUMBBELL TUMOUR WAS MADE. SYMPTOMS WERE ALSO MINIMAL; THUS, THE PATIENT WAS SCHEDULED TO BE FOLLOWED UP. HOWEVER, AT THE TIME OF THE VISIT FOR MONTH X-2, NUMBNESS IN BOTH LOWER EXTREMITIES, ILIOPSOAS MUSCLE WEAKNESS, AND GAIT SPASTIC APPEARED, AND THE SPINAL CORD SYMPTOMS WORSENED; THUS, THE PATIENT WAS SCHEDULED TO UNDERGO SURGERY AND TREATMENT. A CONTRAST-ENHANCED CT SHOWED CLEAR ARTERIAL SUPPLY AROUND THE TUMOUR; THUS, EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED THE DAY BEFORE SURGERY. SINCE THE DAY AFTER SURGERY, PYREXIA EXCEEDING 38°C AND RIGHT CHEST PAIN APPEARED, THE SURGERY SCHEDULED WAS POSTPONED. ALTHOUGH BLOOD DRAWS AND IMAGING TESTS WERE PERFORMED, THERE WAS NO OBVIOUS SOURCE OF HEAT, AND PYREXIA AND CHEST PAIN WERE ALSO ALLEVIATED ON DAY 5 AFTER EMBOLIZATION. THUS, SYMPTOMS DUE TO POST-EMBOLIZATION SYNDROME WERE SUSPECTED BASED ON THE CLINICAL COURSE. WHEN NEUROLOGICAL SYMPTOMS WERE CONFIRMED AGAIN ON DAY 7 OF EMBOLIZATION, GAIT SPASTIC IMPROVED, AND AN MRI PERFORMED 4 WEEKS AFTER EMBOLIZATION SHOWED AN INCREASE IN FLUID COMPONENTS INSIDE THE TUMOUR. SINCE THE GENERAL CONDITION HAD ALSO IMPROVED, TUMOURECTOMY WAS PERFORMED 6 WEEKS LATER. THE AUTHOR EXPERIENCED A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED AFTER EMBOLIZATION. SINCE SURGERY WAS INCIDENTALLY POSTPONED DUE TO POST-EMBOLIZATION SYNDROME, IT WAS POSSIBLE TO EVALUATE THE EFFECT OF EMBOLIZATION. IT IS THOUGHT THAT TISSUE NECROSIS CAUSED BY EMBOLIZATION LED TO A DECREASE IN THE INTERNAL PRESSURE, THEREBY DECREASING THE DEGREE OF SPINAL CORD COMPRESSION. FURTHER STUDIES ARE NEEDED ON THE COMPLICATIONS AND EFFECTS OF EMBOLIZATION. CAUSALITY FOR "EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED", "POST-EMBOLIZATION SYNDROME", "PYREXIA", "RIGHT CHEST PAIN APPEARED" AND "SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (16OCT2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON (B)(6) 2025 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: DEI CONCLUSION. THIS RECORD SHOULD BE CANCELLED BECAUSE THE PRODUCT IS OUT OF SCOPE FOR DEVICE ENGINEERING INVESTIGATIONS. NO FURTHER MANUFACTURING INVESTIGATION WAS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE WAS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED. FOLLOW-UP (06NOV2025): THIS IS A LITERATURE SPONTANEOUS FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. UPDATED INFORMATION: DEVICE PROBLEM CODE ADDED., COMMENT: THERE IS A REASONABLE POSSIBILITY THAT THE EVENTS WERE RELATED TO ABSORBABLE GELATIN BASED ON THE TEMPORAL ASSOCIATION.
EVENT VERBATIM [PREFERRED TERM] , EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED [OFF LABEL USE], EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED [DEVICE USE ISSUE], POST-EMBOLIZATION SYNDROME [POST EMBOLISATION SYNDROME], PYREXIA [PYREXIA], RIGHT CHEST PAIN APPEARED [CHEST PAIN], SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED [THERAPEUTIC RESPONSE UNEXPECTED], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED AFTER PREOPERATIVE EMBOLIZATION", JOURNAL OF THE EASTERN JAPAN ASSOCIATION OF ORTHOPEDICS AND TRAUMATOLOGY, 2025; VOL:37(3), PGS:314. A 53-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "THORACIC SPINAL CORD DUMBBELL TUMOUR" (ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED"; POST EMBOLISATION SYNDROME (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "POST-EMBOLIZATION SYNDROME"; PYREXIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING"; CHEST PAIN (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING", DESCRIBED AS "RIGHT CHEST PAIN APPEARED"; THERAPEUTIC RESPONSE UNEXPECTED (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED". CLINICAL COURSE: PREOPERATIVE EMBOLIZATION OF SPINAL TUMOURS IS WIDELY USED IN BONE TUMOURS AND METASTATIC TUMOURS TO SUPPRESS THE VOLUME OF OPERATIVE HAEMORRHAGE. IN CONTRAST, COMPLICATIONS SUCH AS SKIN NECROSIS AND TRANSIENT PARALYSIS HAVE ALSO BEEN REPORTED FOR EMBOLIZATION. THE AUTHOR REPORTED THEIR EXPERIENCE WITH A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TRANSIENTLY IMPROVED BY PREOPERATIVE EMBOLIZATION. A 53-YEAR-OLD MAN. DURING A WORKPLACE HEALTH CHECKUP, AN ABNORMAL SHADOW ON THE CHEST WAS POINTED OUT, AND THE PATIENT VISITED A LOCAL DOCTOR IN YEAR X-3. A CT SHOWED A MASS IN THE PARAVERTEBRAL BODY; THUS, THE PATIENT WAS REFERRED TO THE HOSPITAL. AT THE TIME OF THE INITIAL VISIT, THE PATIENT HAD PAIN ONLY IN THE RIGHT T10 REGION, AND NO NEUROLOGICAL FINDINGS ABNORMAL WERE OBSERVED. AN MRI SHOWED A 43 MM X 50 MM TUMOUR EXTENDING FROM THE T9/10 RIGHT INTERVERTEBRAL FORAMEN INTO THE THORACIC CAVITY, AND A DIAGNOSIS OF A DUMBBELL TUMOUR WAS MADE. SYMPTOMS WERE ALSO MINIMAL; THUS, THE PATIENT WAS SCHEDULED TO BE FOLLOWED UP. HOWEVER, AT THE TIME OF THE VISIT FOR MONTH X-2, NUMBNESS IN BOTH LOWER EXTREMITIES, ILIOPSOAS MUSCLE WEAKNESS, AND GAIT SPASTIC APPEARED, AND THE SPINAL CORD SYMPTOMS WORSENED; THUS, THE PATIENT WAS SCHEDULED TO UNDERGO SURGERY AND TREATMENT. A CONTRAST-ENHANCED CT SHOWED CLEAR ARTERIAL SUPPLY AROUND THE TUMOUR; THUS, EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED THE DAY BEFORE SURGERY. SINCE THE DAY AFTER SURGERY, PYREXIA EXCEEDING 38°C AND RIGHT CHEST PAIN APPEARED, THE SURGERY SCHEDULED WAS POSTPONED. ALTHOUGH BLOOD DRAWS AND IMAGING TESTS WERE PERFORMED, THERE WAS NO OBVIOUS SOURCE OF HEAT, AND PYREXIA AND CHEST PAIN WERE ALSO ALLEVIATED ON DAY 5 AFTER EMBOLIZATION. THUS, SYMPTOMS DUE TO POST-EMBOLIZATION SYNDROME WERE SUSPECTED BASED ON THE CLINICAL COURSE. WHEN NEUROLOGICAL SYMPTOMS WERE CONFIRMED AGAIN ON DAY 7 OF EMBOLIZATION, GAIT SPASTIC IMPROVED, AND AN MRI PERFORMED 4 WEEKS AFTER EMBOLIZATION SHOWED AN INCREASE IN FLUID COMPONENTS INSIDE THE TUMOUR. SINCE THE GENERAL CONDITION HAD ALSO IMPROVED, TUMOURECTOMY WAS PERFORMED 6 WEEKS LATER. THE AUTHOR EXPERIENCED A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED AFTER EMBOLIZATION. SINCE SURGERY WAS INCIDENTALLY POSTPONED DUE TO POST-EMBOLIZATION SYNDROME, IT WAS POSSIBLE TO EVALUATE THE EFFECT OF EMBOLIZATION. IT IS THOUGHT THAT TISSUE NECROSIS CAUSED BY EMBOLIZATION LED TO A DECREASE IN THE INTERNAL PRESSURE, THEREBY DECREASING THE DEGREE OF SPINAL CORD COMPRESSION. FURTHER STUDIES ARE NEEDED ON THE COMPLICATIONS AND EFFECTS OF EMBOLIZATION.THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. CAUSALITY FOR "EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED", "POST-EMBOLIZATION SYNDROME", "PYREXIA", "RIGHT CHEST PAIN APPEARED" AND "SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (16OCT2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 16OCT2025 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: DEI CONCLUSION. THIS RECORD SHOULD BE CANCELLED BECAUSE THE PRODUCT IS OUT OF SCOPE FOR DEVICE ENGINEERING INVESTIGATIONS. NO FURTHER MANUFACTURING INVESTIGATION WAS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE WAS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED., COMMENT: THERE IS A REASONABLE POSSIBILITY THAT THE EVENTS WERE RELATED TO ABSORBABLE GELATIN BASED ON THE TEMPORAL ASSOCIATION.
EVENT [PREFERRED TERM] EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED [OFF LABEL USE], EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED [DEVICE USE ISSUE], POST-EMBOLIZATION SYNDROME [POST EMBOLISATION SYNDROME], PYREXIA [PYREXIA], RIGHT CHEST PAIN APPEARED [CHEST PAIN], SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED [THERAPEUTIC RESPONSE UNEXPECTED], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED AFTER PREOPERATIVE EMBOLIZATION", JOURNAL OF THE EASTERN JAPAN ASSOCIATION OF ORTHOPEDICS AND TRAUMATOLOGY, 2025; VOL:37(3), PGS:314. A 53-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "THORACIC SPINAL CORD DUMBBELL TUMOUR" (ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED"; POST EMBOLISATION SYNDROME (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "POST-EMBOLIZATION SYNDROME"; PYREXIA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING"; CHEST PAIN (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERING", DESCRIBED AS "RIGHT CHEST PAIN APPEARED"; THERAPEUTIC RESPONSE UNEXPECTED (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED". CLINICAL COURSE: PREOPERATIVE EMBOLIZATION OF SPINAL TUMOURS IS WIDELY USED IN BONE TUMOURS AND METASTATIC TUMOURS TO SUPPRESS THE VOLUME OF OPERATIVE HAEMORRHAGE. IN CONTRAST, COMPLICATIONS SUCH AS SKIN NECROSIS AND TRANSIENT PARALYSIS HAVE ALSO BEEN REPORTED FOR EMBOLIZATION. THE AUTHOR REPORTED THEIR EXPERIENCE WITH A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TRANSIENTLY IMPROVED BY PREOPERATIVE EMBOLIZATION. A 53-YEAR-OLD MAN. DURING A WORKPLACE HEALTH CHECKUP, AN ABNORMAL SHADOW ON THE CHEST WAS POINTED OUT, AND THE PATIENT VISITED A LOCAL DOCTOR IN YEAR X-3. A CT SHOWED A MASS IN THE PARAVERTEBRAL BODY; THUS, THE PATIENT WAS REFERRED TO THE HOSPITAL. AT THE TIME OF THE INITIAL VISIT, THE PATIENT HAD PAIN ONLY IN THE RIGHT T10 REGION, AND NO NEUROLOGICAL FINDINGS ABNORMAL WERE OBSERVED. AN MRI SHOWED A 43 MM X 50 MM TUMOUR EXTENDING FROM THE T9/10 RIGHT INTERVERTEBRAL FORAMEN INTO THE THORACIC CAVITY, AND A DIAGNOSIS OF A DUMBBELL TUMOUR WAS MADE. SYMPTOMS WERE ALSO MINIMAL; THUS, THE PATIENT WAS SCHEDULED TO BE FOLLOWED UP. HOWEVER, AT THE TIME OF THE VISIT FOR MONTH X-2, NUMBNESS IN BOTH LOWER EXTREMITIES, ILIOPSOAS MUSCLE WEAKNESS, AND GAIT SPASTIC APPEARED, AND THE SPINAL CORD SYMPTOMS WORSENED; THUS, THE PATIENT WAS SCHEDULED TO UNDERGO SURGERY AND TREATMENT. A CONTRAST-ENHANCED CT SHOWED CLEAR ARTERIAL SUPPLY AROUND THE TUMOUR; THUS, EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED THE DAY BEFORE SURGERY. SINCE THE DAY AFTER SURGERY, PYREXIA EXCEEDING 38°C AND RIGHT CHEST PAIN APPEARED, THE SURGERY SCHEDULED WAS POSTPONED. ALTHOUGH BLOOD DRAWS AND IMAGING TESTS WERE PERFORMED, THERE WAS NO OBVIOUS SOURCE OF HEAT, AND PYREXIA AND CHEST PAIN WERE ALSO ALLEVIATED ON DAY 5 AFTER EMBOLIZATION. THUS, SYMPTOMS DUE TO POST-EMBOLIZATION SYNDROME WERE SUSPECTED BASED ON THE CLINICAL COURSE. WHEN NEUROLOGICAL SYMPTOMS WERE CONFIRMED AGAIN ON DAY 7 OF EMBOLIZATION, GAIT SPASTIC IMPROVED, AND AN MRI PERFORMED 4 WEEKS AFTER EMBOLIZATION SHOWED AN INCREASE IN FLUID COMPONENTS INSIDE THE TUMOUR. SINCE THE GENERAL CONDITION HAD ALSO IMPROVED, TUMOURECTOMY WAS PERFORMED 6 WEEKS LATER. THE AUTHOR EXPERIENCED A CASE OF THORACIC SPINAL CORD DUMBBELL TUMOUR IN WHICH SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED AFTER EMBOLIZATION. SINCE SURGERY WAS INCIDENTALLY POSTPONED DUE TO POST-EMBOLIZATION SYNDROME, IT WAS POSSIBLE TO EVALUATE THE EFFECT OF EMBOLIZATION. IT IS THOUGHT THAT TISSUE NECROSIS CAUSED BY EMBOLIZATION LED TO A DECREASE IN THE INTERNAL PRESSURE, THEREBY DECREASING THE DEGREE OF SPINAL CORD COMPRESSION. FURTHER STUDIES ARE NEEDED ON THE COMPLICATIONS AND EFFECTS OF EMBOLIZATION.THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. CAUSALITY FOR "EMBOLIZATION WITH A GELATIN SPONGE WAS PERFORMED", "POST-EMBOLIZATION SYNDROME", "PYREXIA", "RIGHT CHEST PAIN APPEARED" AND "SPINAL CORD SYMPTOMS TEMPORARILY IMPROVED" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION)., COMMENT: THERE IS A REASONABLE POSSIBILITY THAT THE EVENTS WERE RELATED TO ABSORBABLE GELATIN BASED ON THE TEMPORAL ASSOCIATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449179 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Required Intervention| O |