BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 1715940 · Received June 9, 2010

    Report

    Report Number
    2242352-2010-01589
    Event Type
    Death
    Date Received
    June 9, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 11, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO CARDIAC SURGERY FOR INVESTIGATION, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED PRODUCT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT, AS REPORTED TO US. A DEVICE LOT HISTORY COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. A MEDICAL REVIEW PERFORMED REVEALED THAT, AS PER OUR IFU, WE CONTRAINDICATE TO USE THE DEVICE IN PRESENCE OF A PALPABLE DISEASE OF THE AORTA. IN THIS PARTICULAR CASE THE MANIPULATION OF THE AORTA CAUSED A SEVERE RUPTURE OF THE AORTA THAT COULD NOT BE ADDRESSED SURGICALLY AND THE PT EXPIRED. AORTIC RUPTURE AND DISSECTION IS A WELL KNOWN COMPLICATION FOR CORONARY ARTERY BYPASS PROCEDURE AND THE INCIDENCE INCREASES WITH THE SEVERITY OF THE DISEASE AT THE LEVEL OF THE AORTIC WALL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. (B) (4)

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT WHILE USING A HEARTSTRING III PROXIMAL SEAL SYSTEM IN A CORONARY ARTERY BYPASS PROCEDURE, AN ADVERSE EVENT OCCURRED. IN A CONVERSATION BETWEEN THE SURGEON AND THE COMPANY REPRESENTATIVE, THE PHYSICIAN REPORTED THAT AFTER HE DEPLOYED THE SEAL, THE TENSION SPRING ASSEMBLY MIGHT HAVE TORN THE AORTA. THE SURGEON USED A CROSS CLAMP AND TRIED TO SEW THE AORTA BUT THE PT DIED. THE SURGEON ALSO SAID THAT IT WAS A VERY CALCIFIED AORTA AND THAT THERE MIGHT HAVE BEEN OTHER FACTORS INVOLVED THAT LED TO THIS EVENT. HE IS A VERY EXPERIENCED USER WITH THE HEARTSTRING III PROXIMAL SEAL SYSTEM. THE DOCTOR DID NOT REPORT A PRODUCT MALFUNCTION, AS HE WAS JUST DISCUSSING WITH THE COMPANY REPRESENTATIVE WHAT HAD HAPPENED DURING SURGERY. THE SURGEON REPORTED THAT HE WAS TRYING TO FIGURE OUT WHAT COULD HAVE CAUSED THE TEAR IN THE AORTA. 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