BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE

    MDR report key: 3841610 · Received May 30, 2014

    Report

    Report Number
    1063481-2014-00023
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 12, 2006
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE ARTICLE PUBLISHED IN THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, BIOGLUE WAS USED TO REINFORCE THE SUTURE LINE OF THE LEFT APICAL VENTRICULOTOMY IN A (B)(6) PATIENT. THE PATIENT PRESENTED WITH A "MEDIASTINAL ABSCESS" 7 MONTHS AFTER SURGICAL INTERVENTION. THE CYST WAS DRAINED AND ARTIFICIAL MATERIAL WAS FOUND WITHIN THE CAVITY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, ONLY MINIMAL INFORMATION WAS ABLE TO BE OBTAINED. THE SURGEON INFORMED CRYOLIFE THAT HE BELIEVES THE CASE OCCURRED SOMETIME IN 2004. THE PATIENT'S ABSCESS WAS ASPIRATED AND SCOPED, AND THE PATIENT MADE A FULL AND UNEVENTFUL RECOVERY. THE SURGEON STATED THAT THE PAPER WAS PUBLISHED TO DEMONSTRATE WHAT HAPPENS WHEN BIOGLUE IS USED IN A PROCEDURE IT IS NOT INTENDED FOR, IN THIS CASE SEALING AN ANEURYSM IN THE LEFT APEX OF THE HEART. BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, A DEFINITIVE ROOT CAUSE OF THE OBSERVED EVENT CANNOT BE DETERMINED. WHILE IT IS UNKNOWN THE AMOUNT OF BIOGLUE THAT WAS USED IN THE PRIMARY PROCEDURE, THE FACT THAT AN "IRREGULAR MASS OF ARTIFICIAL MATERIAL" THAT WAS 2 CM IN DIAMETER WAS RECOVERED FROM WITHIN THE CAVITY ALONG WITH THE FLUID COLLECTION SUGGESTS THAT BIOGLUE MAY NOT HAVE BEEN APPLIED IN THIN, EVEN LAYERS DURING THE PRIMARY PROCEDURE AS CRYOLIFE RECOMMENDS. GIVEN THE LENGTH OF TIME BETWEEN THE PROCEDURE IN WHICH BIOGLUE WAS USED AND THE ONSET OF THE COLLECTION, IT IS UNLIKELY THAT BIOGLUE WAS THE PRIMARY CAUSE OF THE ASEPTIC MEDIASTINAL CYST. IT IS ALSO POSSIBLE THAT THIS EVENT REPRESENTS AN INFLAMMATORY RESPONSE TO BIOGLUE; THIS IS A KNOWN POTENTIAL COMPLICATION COMMUNICATED IN THE DEVICE'S INSTRUCTIONS FOR USE. NO DEFINITIVE CONCLUSIONS CAN BE MADE WITH THE AVAILABLE INFORMATION TO DETERMINE IF BIOGLUE CONTRIBUTED TO THE REPORTED EVENT. THIS EVENT HAS BEEN IDENTIFIED AS AN ABNORMAL ("OFF-LABEL") USE BY THE SURGEON.

    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 ARTICLE PUBLISHED IN THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, BIOGLUE WAS USED TO REINFORCE THE SUTURE LINE OF THE LEFT APICAL VENTRICULOTOMY IN A (B)(6) PATIENT. THE PATIENT PRESENTED WITH A "MEDIASTINAL ABSCESS" 7 MONTHS AFTER SURGICAL INTERVENTION. THE CYST WAS DRAINED AND ARTIFICIAL MATERIAL WAS FOUND WITHIN THE CAVITY.

    Description of Event or Problem · 1

    ACCORDING TO THE ARTICLE PUBLISHED IN THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, BIOGLUE WAS USED TO REINFORCE THE SUTURE LINE OF THE LEFT APICAL VENTRICULOTOMY IN A (B)(6) PATIENT. THE PATIENT PRESENTED WITH A "MEDIASTINAL ABSCESS" 7 MONTHS AFTER SURGICAL INTERVENTION. THE CYST WAS DRAINED AND ARTIFICIAL MATERIAL WAS FOUND WITHIN THE CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318460 BIOGLUE SURGICAL ADHESIVE MUQ CRYOLIFE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other