ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2023-00213
- Event Type
- Injury
- Date Received
- May 26, 2023
- Report Date
- May 8, 2023
- Manufacturer
- PFIZERINC
- 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 CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE 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.
EVENT VERBATIM [PREFERRED TERM] INDICATION: OPERATION OF NUTRIENT VESSEL EMBOLISATION [OFF LABEL USE], INDICATION: OPERATION OF NUTRIENT VESSEL EMBOLISATION [DEVICE USE ISSUE], GELATIN SPONGE/WHICH MAY HAVE LED TO THE RECURRENCE/LUMBAR AGGRESSIVE HEMANGIOMA RECURRING [HAEMANGIOMA], GELATIN SPONGE/WHICH MAY HAVE LED TO THE RECURRENCE/LUMBAR AGGRESSIVE HEMANGIOMA RECURRING [DISEASE RECURRENCE]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LUMBAR AGGRESSIVE HEMANGIOMA RECURRING AFTER VERTEBROPLASTY: A CASE REPORT", JOURNAL OF THE EASTERN JAPAN ASSOCIATION OF ORTHOPAEDICS AND TRAUMATOLOGY, 2023; VOL:35, PGS:34-39. A 23-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "INTRAORAL CYST" (UNSPECIFIED IF ONGOING); "LEFT CALCANEUS FRACTURE" (UNSPECIFIED IF ONGOING); "HAEMANGIOMA" (UNSPECIFIED IF 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 "RECOVERED" AND ALL DESCRIBED AS "INDICATION: OPERATION OF NUTRIENT VESSEL EMBOLISATION"; HAEMANGIOMA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DISEASE RECURRENCE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED" AND ALL DESCRIBED AS "GELATIN SPONGE/WHICH MAY HAVE LED TO THE RECURRENCE/LUMBAR AGGRESSIVE HEMANGIOMA RECURRING". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BIOPSY: ABUNDANT BLOOD FLOW AND TISSUES, NOTES: CORRESPONDING TO THE VESSELS; MAGNETIC RESONANCE IMAGING: GDENHANCED LESIONS, NOTES: EXTENDING FROM THE L3 VERTEBRAL BODY TO THE SPINAL CANAL IN SOME PARTS, WITH LOW INTENSITIES ON T1-WEIGHTED IMAGING AND HIGH INTENSITIES ON T2- WEIGHED IMAGING; LESION WITH LOW INTENSITIES ON T1- WEIGHTED IMAGING, NOTES: HIGH INTENSITIES ON T2- WEIGHED IMAGING IN THE L3 VERTEBRAL BODY AND TUMOUR INVASION INTO THE SPINAL CANAL, PREDOMINANTLY IN THE RIGHT SIDE; PHYSICAL FINDINGS: PAIN LEGS INCREASED WHEN BENDING FORWARD, NOTES: THERE WERE NO ABNORMAL NEUROLOGICAL FINDINGS; THERE WERE NO NEUROLOGICAL FINDINGS ABNORMAL; X-RAY: TRABECULAR BONES WERE NOTICEABLE; NO APPARENT CHANGE WAS OBSERVED, NOTES: ALTHOUGH B-TCP TENDED TO BE ABSORBED; SPOTTY THICKENED TRABECULAR BONES, NOTES: IN THE L3 VERTEBRAL BODY; DECREASED TRANSLUCENCY, NOTES: BUT THERE WERE NO FINDINGS SUGGESTIVE OF RECURRENCE. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF HAEMANGIOMA, DISEASE RECURRENCE. CLINICAL COURSE: THE PATIENT VISITED THE PREVIOUS HOSPITAL DUE TO LOW BACK PAIN, WHICH PERSISTED FOR ONE MONTH; HE WAS SUSPECTED TO HAVE TUMOUR IN THE L3 VERTEBRAL BODY AND WAS REFERRED TO AND EXAMINED AT HOSPITAL. PHYSICAL FINDINGS: PAIN LEGS INCREASED WHEN BENDING FORWARD. THERE WERE NO ABNORMAL NEUROLOGICAL FINDINGS. IMAGING FINDINGS: TRABECULAR BONES WERE NOTICEABLE ON PLAIN X-RAY, AND MRI REVEALED GDENHANCED LESIONS, EXTENDING FROM THE L3 VERTEBRAL BODY TO THE SPINAL CANAL IN SOME PARTS, WITH LOW INTENSITIES ON T1-WEIGHTED IMAGING AND HIGH INTENSITIES ON T2-WEIGHED IMAGING. CT-GUIDED BIOPSY CONFIRMED ABUNDANT BLOOD FLOW AND TISSUES CORRESPONDING TO THE VESSELS, AND THE PATIENT WAS DIAGNOSED WITH HAEMANGIOMA AND WAS DECIDED TO BE PLACED UNDER COURSE OBSERVATION. SINCE THE LOW BACK PAIN WORSENED FOUR MONTHS LATER AND PATHOLOGICAL FRACTURE OF THE L3 VERTEBRAL BODY WAS OBSERVED, SURGERY WAS DECIDED TO BE PERFORMED. EMBOLIZATION WAS NOT SUFFICIENTLY PERFORMED BECAUSE THE PATIENT WAS SCARED OF MOVEMENTS INVOLUNTARY OF LOWER LIMBS THAT OCCURRED DURING THE OPERATION OF NUTRIENT VESSEL EMBOLISATION USING GELATIN SPONGE. VERTEBROPLASTY USING B-TCP WAS PERFORMED AFTER EMBOLISATION, AND THE PAIN LEGS DISAPPEARED. THE PATIENT RETURNED TO WORK. THREE YEARS AFTER VERTEBROPLASTY: THE PATIENT COMPLAINT LOW BACK PAIN AND NUMBNESS OF BOTH LOWER LIMBS. THE PATIENT FELL FROM A HEIGHT OF 2 M AT WORK AND WAS REFERRED FROM HIS LOCAL HOSPITAL DUE TO A FLARE-UP OF LOW BACK PAIN. IMAGING FINDINGS: ALTHOUGH B-TCP TENDED TO BE ABSORBED ON PLAIN X-RAY, NO APPARENT CHANGE WAS OBSERVED IN BONE MORPHOLOGY. MRI REVEALED LESION WITH LOW INTENSITIES ON T1- WEIGHTED IMAGING AND HIGH INTENSITIES ON T2-WEIGHED IMAGING IN THE L3 VERTEBRAL BODY AND TUMOUR INVASION INTO THE SPINAL CANAL, PREDOMINANTLY IN THE RIGHT SIDE, AND RECURRENCE WAS SUSPECTED. PHYSICAL FINDINGS: THERE WERE NO NEUROLOGICAL FINDINGS ABNORMAL. TREATMENT COURSE: AS THE PATIENT REQUESTED LESS INVASIVE TREATMENT THAN CURETTAGE, ETC., SCLEROTHERAPY BY THE RADIOLOGY DEPARTMENT OF HOSPITAL WAS DECIDED TO BE PERFORMED. AFTER CONTRAST MEDIA WAS INFUSED UNDER CT GUIDANCE, THE RIGHT SIDE OF L3 AND THE THIRD AND FIFTH LUMBAR ARTERIES WERE VISUALIZED. PD FOAM WAS INFUSED INTO THE VERTEBRAL BODY AS A SCLEROSING AGENT, AND THE EMBOLISATION ROUTE WAS FILLED WITH NBUTYL-2-CYANOACRYLATE. LOW BACK PAIN AND NUMBNESS OF BOTH LOWER LIMBS IMPROVED, AND THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL ON THE SECOND POSTOPERATIVE DAY. THE PATIENT WAS INSTRUCTED TO WEAR A SOFT CORSET FOR ONE MONTH AFTER THE SURGERY. PLAIN XRAY TWO MONTHS AFTER THE SURGERY REVEALED SPOTTY THICKENED TRABECULAR BONES IN THE L3 VERTEBRAL BODY. X-RAY SIX MONTHS AFTER THE SURGERY REVEALED DECREASED TRANSLUCENCY (FIGURE 6), BUT THERE WERE NO FINDINGS SUGGESTIVE OF RECURRENCE. THE AUTHOR STATED THE COMPLETION OF THE ARTERY EMBOLISATION BEFORE THE FIRST SURGERY WHILE EFFECTS OF CONTRAST ENHANCEMENT REMAINED IN THE THIRD LUMBAR ARTERY IS LISTED AS A CAUSE OF RECURRENCE IN THE PRESENT CASE. ALTHOUGH GELATIN SPONGE MAY ACHIEVE COMPLETE EMBOLISATION, BLOOD FLOW IS OFTEN RECANALIZED AFTER ITS ABSORPTION, WHICH MAY HAVE LED TO THE RECURRENCE. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 04DEC2023 FOR ABSORBABLE GELATIN: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE 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. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (04DEC2023): THIS IS A FOLLOW-UP REPORT FROM PFIZER PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS LITERATURE REPORT, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT TO THE REPORTED EVENTS CANNOT BE EXCLUDED. CASE WILL BE REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION.
EVENT VERBATIM [PREFERRED TERM] INDICATION: OPERATION OF NUTRIENT VESSEL EMBOLISATION [OFF LABEL USE], INDICATION: OPERATION OF NUTRIENT VESSEL EMBOLISATION [DEVICE USE ISSUE], GELATIN SPONGE/WHICH MAY HAVE LED TO THE RECURRENCE/LUMBAR AGGRESSIVE HEMANGIOMA RECURRING [HAEMANGIOMA], GELATIN SPONGE/WHICH MAY HAVE LED TO THE RECURRENCE/LUMBAR AGGRESSIVE HEMANGIOMA RECURRING [DISEASE RECURRENCE], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LUMBAR AGGRESSIVE HEMANGIOMA RECURRING AFTER VERTEBROPLASTY: A CASE REPORT", JOURNAL OF THE EASTERN JAPAN ASSOCIATION OF ORTHOPAEDICS AND TRAUMATOLOGY, 2023; VOL:35, PGS:34-39. A 23-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "INTRAORAL CYST" (UNSPECIFIED IF ONGOING); "LEFT CALCANEUS FRACTURE" (UNSPECIFIED IF ONGOING); "HAEMANGIOMA" (UNSPECIFIED IF 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 "RECOVERED" AND ALL DESCRIBED AS "INDICATION: OPERATION OF NUTRIENT VESSEL EMBOLISATION"; HAEMANGIOMA (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DISEASE RECURRENCE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED" AND ALL DESCRIBED AS "GELATIN SPONGE/WHICH MAY HAVE LED TO THE RECURRENCE/LUMBAR AGGRESSIVE HEMANGIOMA RECURRING". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: BIOPSY: ABUNDANT BLOOD FLOW AND TISSUES, NOTES: CORRESPONDING TO THE VESSELS; MAGNETIC RESONANCE IMAGING: GDENHANCED LESIONS, NOTES: EXTENDING FROM THE L3 VERTEBRAL BODY TO THE SPINAL CANAL IN SOME PARTS, WITH LOW INTENSITIES ON T1-WEIGHTED IMAGING AND HIGH INTENSITIES ON T2-WEIGHED IMAGING; LESION WITH LOW INTENSITIES ON T1-WEIGHTED IMAGING, NOTES: HIGH INTENSITIES ON T2-WEIGHED IMAGING IN THE L3 VERTEBRAL BODY AND TUMOUR INVASION INTO THE SPINAL CANAL, PREDOMINANTLY IN THE RIGHT SIDE; PHYSICAL FINDINGS: PAIN LEGS INCREASED WHEN BENDING FORWARD, NOTES: THERE WERE NO ABNORMAL NEUROLOGICAL FINDINGS; THERE WERE NO NEUROLOGICAL FINDINGS ABNORMAL; X-RAY: TRABECULAR BONES WERE NOTICEABLE; NO APPARENT CHANGE WAS OBSERVED, NOTES: ALTHOUGH ¿-TCP TENDED TO BE ABSORBED; SPOTTY THICKENED TRABECULAR BONES, NOTES: IN THE L3 VERTEBRAL BODY; DECREASED TRANSLUCENCY, NOTES: BUT THERE WERE NO FINDINGS SUGGESTIVE OF RECURRENCE. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF HAEMANGIOMA, DISEASE RECURRENCE. CLINICAL COURSE: THE PATIENT VISITED THE PREVIOUS HOSPITAL DUE TO LOW BACK PAIN, WHICH PERSISTED FOR ONE MONTH; HE WAS SUSPECTED TO HAVE TUMOUR IN THE L3 VERTEBRAL BODY AND WAS REFERRED TO AND EXAMINED AT HOSPITAL. PHYSICAL FINDINGS: PAIN LEGS INCREASED WHEN BENDING FORWARD. THERE WERE NO ABNORMAL NEUROLOGICAL FINDINGS. IMAGING FINDINGS: TRABECULAR BONES WERE NOTICEABLE ON PLAIN X-RAY, AND MRI REVEALED GDENHANCED LESIONS, EXTENDING FROM THE L3 VERTEBRAL BODY TO THE SPINAL CANAL IN SOME PARTS, WITH LOW INTENSITIES ON T1-WEIGHTED IMAGING AND HIGH INTENSITIES ON T2-WEIGHED IMAGING. CT-GUIDED BIOPSY CONFIRMED ABUNDANT BLOOD FLOW AND TISSUES CORRESPONDING TO THE VESSELS, AND THE PATIENT WAS DIAGNOSED WITH HAEMANGIOMA AND WAS DECIDED TO BE PLACED UNDER COURSE OBSERVATION. SINCE THE LOW BACK PAIN WORSENED FOUR MONTHS LATER AND PATHOLOGICAL FRACTURE OF THE L3 VERTEBRAL BODY WAS OBSERVED, SURGERY WAS DECIDED TO BE PERFORMED. EMBOLIZATION WAS NOT SUFFICIENTLY PERFORMED BECAUSE THE PATIENT WAS SCARED OF MOVEMENTS INVOLUNTARY OF LOWER LIMBS THAT OCCURRED DURING THE OPERATION OF NUTRIENT VESSEL EMBOLISATION USING GELATIN SPONGE. VERTEBROPLASTY USING ¿-TCP WAS PERFORMED AFTER EMBOLISATION, AND THE PAIN LEGS DISAPPEARED. THE PATIENT RETURNED TO WORK. THREE YEARS AFTER VERTEBROPLASTY: THE PATIENT COMPLAINT LOW BACK PAIN AND NUMBNESS OF BOTH LOWER LIMBS. THE PATIENT FELL FROM A HEIGHT OF 2 M AT WORK AND WAS REFERRED FROM HIS LOCAL HOSPITAL DUE TO A FLARE-UP OF LOW BACK PAIN. IMAGING FINDINGS: ALTHOUGH ¿-TCP TENDED TO BE ABSORBED ON PLAIN X-RAY, NO APPARENT CHANGE WAS OBSERVED IN BONE MORPHOLOGY. MRI REVEALED LESION WITH LOW INTENSITIES ON T1-WEIGHTED IMAGING AND HIGH INTENSITIES ON T2-WEIGHED IMAGING IN THE L3 VERTEBRAL BODY AND TUMOUR INVASION INTO THE SPINAL CANAL, PREDOMINANTLY IN THE RIGHT SIDE, AND RECURRENCE WAS SUSPECTED. PHYSICAL FINDINGS: THERE WERE NO NEUROLOGICAL FINDINGS ABNORMAL. TREATMENT COURSE: AS THE PATIENT REQUESTED LESS INVASIVE TREATMENT THAN CURETTAGE, ETC., SCLEROTHERAPY BY THE RADIOLOGY DEPARTMENT OF HOSPITAL WAS DECIDED TO BE PERFORMED. AFTER CONTRAST MEDIA WAS INFUSED UNDER CT GUIDANCE, THE RIGHT SIDE OF L3 AND THE THIRD AND FIFTH LUMBAR ARTERIES WERE VISUALIZED. PD FOAM WAS INFUSED INTO THE VERTEBRAL BODY AS A SCLEROSING AGENT, AND THE EMBOLISATION ROUTE WAS FILLED WITH N-BUTYL-2-CYANOACRYLATE. LOW BACK PAIN AND NUMBNESS OF BOTH LOWER LIMBS IMPROVED, AND THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL ON THE SECOND POSTOPERATIVE DAY. THE PATIENT WAS INSTRUCTED TO WEAR A SOFT CORSET FOR ONE MONTH AFTER THE SURGERY. PLAIN X-RAY TWO MONTHS AFTER THE SURGERY REVEALED SPOTTY THICKENED TRABECULAR BONES IN THE L3 VERTEBRAL BODY. X-RAY SIX MONTHS AFTER THE SURGERY REVEALED DECREASED TRANSLUCENCY (FIGURE 6), BUT THERE WERE NO FINDINGS SUGGESTIVE OF RECURRENCE. THE AUTHOR STATED THE COMPLETION OF THE ARTERY EMBOLISATION BEFORE THE FIRST SURGERY WHILE EFFECTS OF CONTRAST ENHANCEMENT REMAINED IN THE THIRD LUMBAR ARTERY IS LISTED AS A CAUSE OF RECURRENCE IN THE PRESENT CASE. ALTHOUGH GELATIN SPONGE MAY ACHIEVE COMPLETE EMBOLISATION, BLOOD FLOW IS OFTEN RECANALIZED AFTER ITS ABSORPTION, WHICH MAY HAVE LED TO THE RECURRENCE. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON THE INFORMATION PROVIDED IN THIS LITERATURE REPORT, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT TO THE REPORTED EVENTS CANNOT BE EXCLUDED. CASE WILL BE REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1436975 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZERINC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Male | Other| R |