BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL

    MDR report key: 1031594 · Received March 24, 2008

    Report

    Report Number
    2953148-2008-00301
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION DETAILS: VISUAL INSPECTION SHOWED THAT THE SEAL WAS OUT OF DEPLOYMENT TUBE, CRACKED AND UNRAVELED. OTHER OBSERVATIONS WAS THAT THE PLUNGER WAS DEPRESSED AND THE TENSION SPRING REMAINED INSIDE THE DEPLOYMENT TUBE. THE FAILURE THAT THE SEAL DID NOT DEPLOY IS CONFIRMED, BASED ON HOW THE SEAL WAS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT, THERE WAS NO NONCONFORMANCE ASSOCIATED WITH THE LOT NUMBER.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, ONE HEARTSTRING SEAL DID NOT DEPLOY OUT OF THE DELIVERY TUBE INTO THE AORTA. A SECOND HEARTSTRING WAS OPENED AND WAS NOTICED TO BE CRACKED OUT OF THE BOX. A THIRD HEARTSTRING SEAL DID NOT DEPLOY COMPLETELY INTO THE AORTA. THE SURGEON REMOVED THE SEAL, CAUSING A TEAR IN THE AORTA. SUTURING WAS USED TO REPAIR THE TEAR AND THE SURGEON DECIDED TO USE PARTIAL OCCLUSION CLAMP TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED BY THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT HAD A FRAGILE AORTIC WALL WITH PRE-EXISTING CORONARY HEART DISEASE. THIS REPORT IS FOR THE THIRD SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL DXC GUIDANT CARDIAC SURGERY HS-1045 7061881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention