BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELFOAM (ABSORBABLE GELATIN) DEVICE

    MDR report key: 1297050 · Received January 28, 2009

    Report

    Report Number
    1810189-2009-00001
    Event Type
    Other
    Date Received
    January 28, 2009
    Report Date
    January 14, 2009
    Manufacturer
    PFIZER, INC. (DEVICE)
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE LITERATURE DESCRIPTION - JOURNAL: THE 93RD KYUSHU REGIONAL MEETING OF THE JAPANESE SOCIETY FOR VASCULAR SURGERY. AUTHOR: KUROU KANAYA. TITLE: A CASE OF ACUTE ARTERY OCCLUSION OF LOWER EXTREMITIES DUE TO DEVIATION OF GELFOAM (GELATIN), YEAR: 2008.

    Description of Event or Problem · 1

    ACUTE ARTERY OCCLUSION OF LOWER EXTREMITY [PERIPHERAL ARTERY OCCLUSION]. CASE DESCRIPTION: THIS IS A LITERATURE REPORT FROM THE ABSTRACTS/PRESENTATION OF A SCIENTIFIC MEETING (93RD KYUSHU REGIONAL MEETING) OF THE JAPANESE SOCIETY FOR VASCULAR SURGERY. THE PT WAS A (B)(6) MALE WHO SUFFERED A PELVIC FRACTURE AND A LEFT TIBIA FRACTURE IN A TRAFFIC ACCIDENT. HE UNDERWENT HAEMOSTATIC EMBOLIZATION WITH ABSORBABLE GELATIN (GELFOAM) FOR PELVIC FRACTURE. ON RETURNING TO HIS ROOM FOLLOWING THE PROCEDURE, HE PRESENTED WITH PALLOR OF THE LEFT LOWER EXTREMITIES AND COMPLETE ISCHEMIA. AN ANGIOGRAM WAS PERFORMED. IT WAS SUSPECTED THAT HE HAD ACUTE ARTERY OCCLUSION OF LOWER EXTREMITIES DUE TO DEVIATION OF GELFOAM, AND AN EMBOLECTOMY WAS IMMEDIATELY PERFORMED. POST OPERATIVELY, THE COLLECTED EMBOLI REVEALED THROMBI INCLUDING GELFOAM. THIS CASE REPORT SHOWS THAT A LIMB COULD BE SALVAGED SUCCESSFULLY DUE TO EMBOLECTOMY FOR EMBOLI. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE PROVIDED AS IT BECOMES AVAILABLE. THE NEED FOR CORRECTIVE ACTION IS BEING EVALUATED AND WILL BE COMMUNICATED IN THE FINAL REPORT. A REVIEW OF PFIZER'S SAFETY DATABASE FOR CASES RECEIVED THROUGH 31 DECEMBER 2008 IDENTIFIED NO SERIOUS CASES FROM SOLICITED CASES AND CLINICAL STUDIES REPORTING ABSORBABLE GELATIN SPONGE OR BLINDED THERAPY AND ADVERSE EVENT S ENCODING TO THE MEDDRA 11.1 PREFERRED TERM, PERIPHERAL ARTERIAL OCCLUSIVE DISEASE. IN ADDITION, NO CASES REPORTED FROM SOURCES OTHER THAN CLINICAL STUDIES WERE IDENTIFIED DURING THIS PERIOD FOR THIS EVENT. BASED ON THE LIMITED INFORMATION PROVIDED IN THIS CASE, THERE IS A POSSIBILITY THAT THE USE OF GELFOAM FOR AN UNAPPROVED USE AND AN INDICATION OTHER THAN AS AN ADJUNCT TO HEMOSTASIS COULD RESULT IN A COMPLICATION LIKE A PERIPHERAL ARTERIAL OCCLUSIVE DISEASE. BASED ON THE INFORMATION PROVIDED IN THE CASE, THIS INDIVIDUAL REPORT WOULD NOT SEEM TO MODIFY THE RISK-BENEFIT PROFILE OF THE SUBJECT DRUG. ROOT CAUSE ANALYSIS FOR THE DEVICE IS UNDER INVESTIGATION AND WILL BE PROVIDED ONCE IT IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention