BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 2904849 · Received January 9, 2013

    Report

    Report Number
    1063481-2013-00002
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P01003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PUBLICATION BY RUIZ-ZAFRA ET AL., THE AUTHORS STATE THAT BIOGLUE CAUSES FALSE POSITIVES IN FDG-PET/CT IMAGING DUE TO FOREIGN BODY REACTIONS TO THE ADHESIVE, WHICH MAY LEAD TO UNNECESSARY SURGERY. THE PATIENT UNDERWENT A LEFT THORACOTOMY AND ATYPICAL PULMONARY RESECTION FOR SQUAMOUS CELL CARCINOMA. BIOGLUE WAS USED AS AN ADJUNCT TO STAPLED SUTURE LINE. SIX MONTH LATER, FDG-PET/CT IMAGING REVEALED THE PRESENCE OF HYPERMETABOLIC FOCI IN THE RESECTED AREA OF THE LEFT UPPER LOBE, WITH A SUVMAX OF 4.66 SUGGESTIVE OF TUMOR REOCCURRENCE. RE-THORACOTOMY WAS REQUIRED, REVEALING THE PRESENCE OF FIBROTIC TISSUE AT THE SURGICAL SITE. THE SURGEONS FOUND AN ENCAPSULATION SURROUNDING THE AREA WHERE THE BIOADHESIVE WAS APPLIED. HISTOLOGICAL STUDY SHOWED A LESION COMPATIBLE WITH FOREIGN BODY GRANULOMA. AN ARTICLE TITLED "PERSISTENT INFLAMMATION IN PULMONARY GRANULOMA 48 YEARS AFTER TALCAGE PLEURODESIS, DETECTED BY FDG-PET/CT" BY FANGGIDAY ET AL. STATES THAT FALSE POSITIVE FINDINGS FROM FDG-PET/CT SCANS ARE NOT UNCOMMON. FOREIGN BODY REACTIONS ARE NOT AN UNEXPECTED RESPONSE TO BIOGLUE AND ARE DESCRIBED IN THE PRODUCT'S INSTRUCTIONS FOR USE. RUIZ-ZAFRA ET AL. EXPLAINS THAT "FDG-PET/CT IS HIGHLY SENSITIVE IN THE DETECTION OF NSCLC REOCCURRENCE. HOWEVER, ITS SPECIFICITY IS LIMITED BECAUSE OF THE ELEVATED FDG CONCENTRATIONS CAUSED BY POSTOPERATIVE INFLAMMATION." WHILE BIOGLUE MAY HAVE CAUSED THE INFLAMMATORY RESPONSES IN THE PATIENTS FROM THE PUBLICATION, MISINTERPRETATION OF THE FDG-PET/CT SCANS CAUSED THE UNNECESSARY REOPERATION ON THE PATIENTS. THE AUTHORS MENTION THAT ANOTHER SCAN AT 90 MIN AFTER RADIOTRACER INJECTION CAN BE USED TO MINIMIZE FALSE-POSITIVE RESULTS BECAUSE "INFLAMMATORY CELLS PROGRESSIVELY SUFFER AN FDG WASHOUT, WHICH RESULTS IN AN SUV DECREASE WITH RESPECT TO THE 60-MIN SCAN." METHODS LIKE THE ONE PROPOSED IN THIS PUBLICATION TO RULE OUT FALSE POSITIVE RESULTS SHOULD BE EMPLOYED TO PREVENT UNNECESSARY INVASIVE PROCEDURES FROM BEING PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION BY RUIZ-ZAFRA ET AL., THE AUTHORS ALLEGE THAT BIOGLUE CAUSES FALSE POSITIVES IN FDG-PET/CT IMAGING DUE TO FOREIGN BODY REACTIONS TO THE ADHESIVE. FDG-PET/CT IMAGING FOUND A HYPERMETABOLIC PULMONARY NODULE IN THE UPPER LEFT LOBE OF THE PATIENT. LEFT THORACOTOMY AND ATYPICAL PULMONARY RESECTION WERE PERFORMED FOLLOWED BY STAPLER SUTURE. BIOGLUE WAS USED AS AN ADJUNCT TO SUTURE WITH STAPLES. SIX MONTH LATER, FDG-PET/CT IMAGING REVEALED THE PRESENCE OF HYPERMETABOLIC FOCI IN THE RESECTED AREA OF THE LEFT UPPER LOBE, WITH A SUVMAX OF 4.66 SUGGESTIVE OF TUMOR REOCCURRENCE. RE-THORACOTOMY WAS REQUIRED, REVEALING THE PRESENCE OF FIBROTIC TISSUE IN THE SURGICAL SITE. THE SURGEONS FOUND AN ENCAPSULATION SURROUNDING THE AREA WHERE THE BIOADHESIVE WAS APPLIED. HISTOLOGICAL STUDY SHOWED A LESION COMPATIBLE WITH FOREIGN BODY GRANULOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11707 BIOGLUE SURGICAL ADHESIVE SURGICAL GLUE MUQ CRYOLIFE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other