BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELFOAM (ABSORBABLE GELATIN) MEDICATED SPONGE

    MDR report key: 3203696 · Received June 24, 2013

    Report

    Report Number
    1810189-2013-00002
    Event Type
    Injury
    Date Received
    June 24, 2013
    Report Date
    May 29, 2013
    Manufacturer
    PFIZER, INC. (DEVICE)
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ATTEMPTS COMPLETED. NO FURTHER INFORMATION EXPECTED. CASE COMMENT: BASED ON THE INFORMATION AVAILABLE, AN ASSOCIATION BETWEEN THE REPORTED EVENTS OF ALLERGIC REACTION WITH NECROTIZING AND HYPERSENSITIVITY VASCULITIS, ENCEPHALITIS ALLERGIC AND SYMPTOMATIC EPILEPSY, AND THE SUSPECT PRODUCTS, GELATIN SPONGE (GELFOAM) AND FIBRIN GLUE CANNOT BE EXCLUDED DUE TO THE CLOSE TEMPORAL RELATIONSHIP AND THE POSITIVE LYMPHOCYTE STIMULATION TEST. HOWEVER, BASED ON THE POST-OPERATIVE DLST FOR CALCIUM CHLORIDE ANHYDROUS, THIS PRODUCT COULD ALSO HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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. REPORT SOURCE LITERATURE DESCRIPTION - JOURNAL: THE 22ND CONFERENCE ON NEUROSURGICAL TECHNIQUES AND TOOLS. AUTHOR: GENKI UEMORI ET AL. TITLE: ALLERGIC REACTION FOLLOWING ARACHNOID PLASTY WITH FIBRIN GLUE AND GELATIN SPONGE FOR A CASE OF UNRUPTURED MIDDLE CEREBRAL ARTERY ANEURYSM. YEAR: 2013, PAGES: 116.

    Description of Event or Problem · 1

    ALLERGIC REACTION [HYPERSENSITIVITY]. HYPERSENSITIVITY VASCULITIS [LEUKOCYTOCLASTIC VASCULITIS]. NECROTIZING VASCULITIS [VASCULITIS NECROTISING]. ENCEPHALITIS ALLERGIC [ENCEPHALITIS ALLERGIC]. SYMPTOMATIC EPILEPSY [EPILEPSY]. EXTREMELY MILD ATTENTIONAL DISORDER [DISTURBANCE IN ATTENTION]. CASE DESCRIPTION: THIS IS A SPONTANEOUS LITERATURE REPORT FROM THE PUBLISHED ABSTRACTS/PRESENTATION OF SCIENTIFIC MEETING, "THE 22ND CONFERENCE ON NEUROSURGICAL TECHNIQUES AND TOOLS, APR2013, P 116, ENTITLED; "ALLERGIC REACTION FOLLOWING ARACHNOID PLASTY WITH FIBRIN GLUE AND GELATIN SPONGE FOR A CASE OF UNRUPTURED MIDDLE CEREBRAL ARTERY ANEURYSM". A 70-YEAR-OLD FEMALE PT OF AN UNSPECIFIED ETHNICITY RECEIVED ABSORBABLE GELATIN (GELFOAM) AND FACTOR 1 (FIBRINOGEN)/THROMBIN (FIBRIN GLUE) DURING ARACHNOID PLASTY ON 31OCT2012 FOR AN UNRUPTURED MIDDLE CEREBRAL ARTERY ANEURYSM. THE PT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ARACHNOID PLASTY WITH FACTOR 1 (FIBRINOGEN)/THROMBIN AND GELATIN SPONGE WAS COMPLETED WITHOUT PROBLEM. ALTHOUGH ABNORMAL FINDINGS WERE NOT DETECTED WITH IMAGE SOON AFTER THE SURGERY, SEIZURE STARTED WITH RIGHT SIDE OF THE BODY AFTER SHE HAD RETURNED HER ROOM. MRI WAS PERFORMED AGAIN BUT DID NOT SHOW ANY ABNORMALITY, AND FOLLOW-UP WAS CONTINUED. NEUROLOGICALLY PERSEVERATION AND SPEECH LOSS WERE CONFIRMED. ON THE 2ND HOSPITAL DAY, MRI DETECTED THE LESION IN LEFT CORTEX OF THE FRONTAL LOBE PRESENTED HIGH DENSITY WITH DWI/T2WI AND LOW DENSITY WITH ADCMAP. MRA CLEARLY SHOWED THE LEFT MIDDLE CEREBRAL ARTERY, AND INCREASE IN CBF AT THE SAME SITE WAS CONFIRMED BY SPECT. THE SITE WAS CONSIDERED AS THE FOCUS OF THE SEIZURE, BUT CEREBROVASCULAR DISORDER WAS DENIED, AND THEN ALLERGIC REACTION DUE TO SUBSTANCES USED FOR ARACHNOID PLASTY WAS SUSPECTED. ADMINISTRATION OF STEROID WAS STARTED, AND ON THE SAME DAY GELATIN SPONGE WAS REMOVED WITH CRANIOTOMY. AFTER THE SURGERY, HIGH DENSITY WITH MRI/DWI GRADUALLY DISAPPEARED AS THE SYMPTOMS WERE IMPROVING, AND IS RETURNED TO THE SAME AS PREOPERATIVE LEVEL, SUBSEQUENTLY SHE WAS DISCHARGED FROM THE HOSPITAL ON THE 22ND HOSPITAL DAY. NECROTIZING AND HYPERSENSITIVITY VASCULITIS SUGGESTIVE OF ALLERGIC REACTION TO GELATIN SPONGE WAS CONFIRMED BY PATHOLOGICAL EXAMINATION. THEREAFTER, LYMPHOCYTE STIMULATION TEST SHOWED POSITIVE FOR GELATIN SPONGE AND FACTOR 1 (FIBRINOGEN)/THROMBIN. FROM THESE RESULTS, IT WAS CONFIRMED AS ALLERGIC REACTION DUE TO SUBSTANCES USED FOR ARACHNOID PLASTY. FOLLOW-UP (13JUN2013): THIS IS A FOLLOW-UP SPONTANEOUS REPORT OBTAINED FROM ANOTHER CONTACTABLE NEUROSURGEON THROUGH A PFIZER SALES REPRESENTATIVE. THE PT WAS IDENTIFIED AS A 70-YEAR-OLD FEMALE, 48 KG IN WEIGHT AND 152 CM IN HEIGHT, NOT PREGNANT. THE PT'S MEDICAL HISTORY INCLUDED UNRUPTURED CEREBRAL ANEURYSM WHICH DEVELOPED 20JUN2011 AND RESOLVED ON 31OCT2012 WITH INTRA-CEREBRAL ANEURYSM OPERATION, AND ONGOING HYPERTENSION FROM UNKNOWN AND ONGOING. THE PT'S CLINICAL COURSE WAS AS FOLLOWS. ON 30OCT2012, THE PT WAS ADMITTED TO THE HOSPITAL. ON 31OCT2012, SHE UNDERWENT INTRA-CEREBRAL ANEURYSM OPERATION. SHE EXPERIENCED ENCEPHALITIS ALLERGIC AND SYMPTOMATIC EPILEPSY. TREATMENT WAS PROVIDED FOR BOTH EVENTS. ON 02NOV2012, FOR CARBAMAZEPINE (TEGRETOL) WAS ADMINISTERED UNTIL 30NOV2012, IN WHICH RASH DEVELOPED. ON 22NOV2012, EXTREMELY MILD ATTENTIONAL DISORDER DUE TO LEFT FRONTAL LOBE DISORDER REMAINED. SHE HAD NO PROBLEMS WITH DAILY ACTIVITIES. FOR SYMPTOMATIC EPILEPSY, PERMANENT ORAL MEDICATION WAS NEEDED. PATHOLOGY SUGGESTED NECROTIZING AND HYPERSENSITIVITY VASCULITIS INDICATIVE OF ALLERGIES. ON 14DEC2012, DRUG-INDUCED LYMPHOCYTE STIMULATION TEST (DLST) SHOWED POSITIVE REACTIONS FOR ABSORBABLE GELATIN (GELFOAM), FACTOR 1 (FIBRINOGEN)/THROMBIN (FIBRIN GLUE), AND CALCIUM CHLORIDE ANHYDROUS (CALCIUM CHLORIDE). ON AN UNSPECIFIED DATE, THE PT RECOVERED FROM ENCEPHALITIS ALLERGIC AND SEQUEL, AND WAS RECOVERING FROM SYMPTOMATIC EPILEPSY. ABSORBABLE GELATIN WAS NOT RE-INTRODUCED. THE REPORTING NEUROSURGEON CLASSIFIED ENCEPHALITIS ALLERGIC AND SYMPTOMATIC EPILEPSY AS SERIOUS (HOSPITALIZATION PROLONGATION), AND ASSESSED THEM AS DEFINITELY RELATED TO ABSORBABLE GELATIN (GELFOAM), FACTOR 1 (FIBRINOGEN)/THROMBIN (FIBRIN GLUE), AND CALCIUM CHLORIDE ANHYDROUS (CALCIUM CHLORIDE). THE REPORTING NEUROSURGEON COMMENTED AS FOLLOWS: ABSORBABLE GELATIN (GELFOAM) WITH ")," FACTOR 1 (FIBRINOGEN)THROMBIN (FIBRIN GLUE) USED FOR SURGERY CAUSED A CHANGE IN THE BRAIN SURFACE. A RESECTED SPECIMEN REVEALED A FINDING SUGGESTIVE OF ALLERGIES. IN ADDITION, THE RESULT OF POST-OPERATIVE DLST WAS POSITIVE FOR ABSORBABLE GELATIN, FACTOR 1 (FIBRINOGEN)/THROMBIN, AND CALCIUM CHLORIDE ANHYDROUS. THUS, THESE 3 DRUGS WERE JUDGED TO HAVE CAUSED ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284767 GELFOAM (ABSORBABLE GELATIN) MEDICATED SPONGE SPONGE, STERILE; CLASS III LMF PFIZER, INC. (DEVICE)

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R