BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 1908109 · Received November 16, 2010

    Report

    Report Number
    2242352-2010-03331
    Event Type
    Death
    Date Received
    November 16, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 18, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. A MEDICAL ASSESSMENT WAS PERFORMED ON THIS EVENT. "AORTIC DISSECTION IS A WELL KNOWN COMPLICATION DURING HEART SURGERY PROCEDURES. THE USAGE OF PROXIMAL ANASTOMOTIC DEVICES REDUCE BUT NOT ELIMINATE THE INCIDENCE OF SUCH A SERIOUS COMPLICATION. (B)(6) DESCRIBED THIS COMPLICATION WITH OUR DEVICE IN THE JOURNAL OF CARDIAC SURGERY 2008 SEP-OCT; 23 (5): 585-6 IN THE PAPER: 'ASCENDING AORTIC DISSECTION AFTER PROXIMAL BYPASS ANASTOMOTIC DEVICE.' IN SOME PATIENTS THE CONDITION OF THE AORTA IS SO SEVERE THAT EVEN IF THE MANIPULATION IS REDUCED TO A MINIMUM WITH OUR DEVICE THERE IS STILL A POSSIBILITY OF INCURRING IN COMPLICATION SUCH AS TEARS AND DISSECTIONS. IN THIS PARTICULAR CASE THAT HAS BEEN REPORTED THERE WAS NO DEVICE MALFUNCTION AND THE COMPLICATION IS DUE TO A SEVERE AORTIC DISEASE." A LOT HISTORY RECORD REVIEW COULD NOT BE COMPLETED FOR THE PRODUCT, AS THE CORRECT LOT NUMBER COULD NOT BE OBTAINED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT FOLLOWING COMPLETION OF A CORONARY ARTERY BYPASS PROCEDURE, A PATIENT HAD A RUPTURED AORTA AND SUBSEQUENTLY EXPIRED. THE HOSPITAL MEDICAL EXAMINER DETERMINED THAT THE RUPTURE WAS DUE TO HYPERTENSION AND WEAK TISSUE. THE REPORTER STATED THAT THE RUPTURE WAS NEAR THE ANASTOMOSIS, BUT THE ANASTOMOSIS WAS INTACT. NO PRODUCT MALFUNCTIONS WERE REPORTED DURING THE PROCEDURE. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death