BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE- UNKNOWN CONFIGURATION

    MDR report key: 19192489 · Received April 26, 2024

    Report

    Report Number
    1063481-2024-00008
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 27, 2024
    Manufacturer
    ARTIVION, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P01003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INITIAL REPORT ON 04/22/2024 FROM CENTURY MEDICAL INC, "AFTER USING THE BIOGLUE IN THE FALSE LUMEN, A MASS OF GLUE WAS FORMED THAT WAS LARGE ENOUGH TO BE VISIBLE FROM THE ADVENTITIA. THERE WAS A RISK OF VASCULAR WALL DAMAGE, THE FALSE LUMEN WAS REOPENED AND THE MASS WAS REMOVED." ADDITIONAL INFORMATION RECEIVED 04/23/2024: "SURGEON NAME: NAME IS UNKNOWN. AMOUNT OF BIOGLUE APPLIED PER SITE: ONE SYRINGE WAS USED, BUT THE EXACT AMOUNT IS UNKNOWN. WHAT WAS THE GROSS CONDITION OF THE AREA WHERE BIOGLUE WAS APPLIED?: NO ABNORMAL FINDINGS." ADDITIONAL INFORMATION RECEIVED 04/23/2024: ¿THE LOT NUMBER WERE NOT BE PROVIDED FROM THE SURGEON. THE PRODUCT IS NOT RETURNED. THE PATIENT IS DOING WELL AFTER THE SURGERY. A SAMPLE EVALUATION WAS NOT PERFORMED AS NO PRODUCT WAS RETURNED.¿ MANUFACTURING RECORDS COULD NOT BE REVIEWED AS NO LOT NUMBERS OR DATES OF SURGERY WERE PROVIDED. THE AVAILABLE INFORMATION WAS REVIEWED. ACCORDING TO THE INITIAL REPORT ON 04/22/2024 FROM CENTURY MEDICAL INC, "AFTER USING THE BIOGLUE IN THE FALSE LUMEN, A MASS OF GLUE WAS FORMED THAT WAS LARGE ENOUGH TO BE VISIBLE FROM THE ADVENTIA. THERE WAS A RISK OF VASCULAR WALL DAMAGE, THE FALSE LUMEN WAS REOPENED AND THE MASS WAS REMOVED." ADDITIONAL INFORMATION RECEIVED 04/23/2024: SURGEON NAME: NAME IS UNKNOWN. AMOUNT OF BIOGLUE APPLIED PER SITE: ONE SYRINGE WAS USED, BUT THE EXACT AMOUNT IS UNKNOWN. WHAT WAS THE GROSS CONDITION OF THE AREA WHERE BIOGLUE WAS APPLIED?: NO ABNORMAL FINDINGS. ADDITIONAL INFORMATION RECEIVED 04/23/2024: THE LOT NUMBER WERE NOT BE PROVIDED FROM THE SURGEON. THE PRODUCT IS NOT RETURNED. THE PATIENT IS DOING WELL AFTER THE SURGERY. BASED ON THE INFORMATION PROVIDED, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE THE CAUSE OF THE MASS FORMATION. THE FOLLOWING INFORMATION WAS NOT PROVIDED AND IS UNKNOWN: THE AMOUNT OF BIOGLUE APPLIED, THE CONDITION OF THE NATIVE TISSUE, WHAT PROCEDURE IT WAS USED FOR, OR IF ANY OTHER PRODUCTS WERE USED DURING THE PROCEDURE. EXPLANTED TISSUE WAS NOT AVAILABLE FOR PATHOLOGICAL EVALUATION TO DETERMINE IF THE MASS IS ACTUALLY BIOGLUE. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE MASS FORMATION. BASED ON THE LIMITED INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSION CAN BE MADE. THE INFORMATION WAS REVIEWED. FOR THIS SPECIFIC EVENT THERE IS INSUFFICIENT EVIDENCE TO DETERMINE A DEFINITIVE ROOT CAUSE AS NO SAMPLE WAS RETURNED TO ARTIVION FOR EVALUATION AND NO PATHOLOGY OR MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE MASS FORMATION. BASED ON THE LIMITED INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSION CAN BE MADE. THE REPORTED EVENTS WILL CONTINUE TO BE MONITORED FOR TRENDS. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. THERE IS INSUFFICIENT INFORMATION TO DETERMINE A ROOT CAUSE. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION- FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT ON 04/22/2024 " AFTER USING THE BIOGLUE IN THE FALSE LUMEN, A MASS OF GLUE WAS FORMED THAT WAS LARGE ENOUGH TO BE VISIBLE FROM THE ADVENTITIA. THERE WAS A RISK OF VASCULAR WALL DAMAGE, THE FALSE LUMEN WAS REOPENED AND THE MASS WAS REMOVED." ADDITIONAL INFORMATION RECEIVED 04/23/2024: SURGEON NAME: NAME IS UNKNOWN AMOUNT OF BIOGLUE APPLIED PER SITE: ONE SYRINGE WAS USED, BUT THE EXACT AMOUNT IS UNKNOWN. WHAT WAS THE GROSS CONDITION OF THE AREA WHERE BIOGLUE WAS APPLIED?: NO ABNORMAL FINDINGS. ADDITIONAL INFORMATION RECEIVED 04/23/2024: THE LOT NUMBER WERE NOT BE PROVIDED FROM THE SURGEON. THE PRODUCT IS NOT RETURNED. THE PATIENT IS DOING WELL AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871494 BIOGLUE- UNKNOWN CONFIGURATION GLUE, SURGICAL, ARTERIES MUQ ARTIVION, INC. BG3510-5-J UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other