BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

    MDR report key: 2247619 · Received September 9, 2011

    Report

    Report Number
    3004114958-2011-00004
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    CARDICA, INC.
    Product Code
    FZP
    PMA / PMN Number
    K081225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PAS-PORT DEVICE, WITH A SECOND PAS-PORT REPORTED IN (B)(4), WAS ONE OF TWO USED IN A CORONARY ARTERY BYPASS GRAFT SURGERY. THE PAS-PORT WAS DEPLOYED BUT THE IMPLANT WAS NOT FIRMLY ATTACHED TO THE AORTA. THE PAS-PORT IMPLANT WAS EXPLANTED AND THE GRAFT WAS HAND SEWN. PT WENT INTO VENTRICULAR FIBRILLATION AND REQUIRED MULTIPLE DEFIBRILLATIONS TO RESTORE NORMAL SINUS RHYTHM. PHYSICIAN REPORTED THAT THE PT WAS "DOING FINE" 1-1/2 WEEKS AFTER THE EVENT. BASED ON DISCUSSION WITH THE SURGEON, VISUALIZATION DIFFICULTY MAY HAVE PREVENTED PLACEMENT OF THE PAS-PORT DEVICE FLUSH TO THE SURFACE OF THE AORTA PRIOR TO DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CLIP, IMPLANTABLE FZP CARDICA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention