BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27)

    MDR report key: 3017794 · Received March 19, 2013

    Report

    Report Number
    3005278776-2013-00007
    Event Type
    Death
    Date Received
    March 19, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 17, 2013
    Manufacturer
    NOVOGI LTD.
    Product Code
    FZP
    PMA / PMN Number
    K093661
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON BEHALF OF THE MFR (NOVOGI LTD) AND THE IMPORTER (B)(4)), A NOVOGI LTD. SERVES AS THE DESIGNATED COMPLAINT HANDLING UNIT FOR BOTH FACILITIES. THE DEVICE WAS NOT RETURNED FOR EVAL, HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO SPECIFICATIONS. THE PT WAS A HIGH RISK PT, SUFFERING FROM MULTIPLE MEDICAL CONDITIONS, INCLUDING CONGESTIVE HEART FAILURE, ISCHEMIC CARDIOMYOPATHY, CHRONIC KIDNEY DISEASE, ASTHMA AND PULMONARY HYPERTENSION AND, ACCORDING TO THE SURGEON, CONSIDERATION WAS GIVEN TO HOSPICE RATHER THAN HAVING THE SURGERY, THUS, MOST LIKELY, PT DEATH IS NOT THE RESULT OF USING THE COLONRING DEVICE. THE PT SUFFERED FROM VARIOUS SERIOUS CO-MORBIDITIES, INCLUDING DIABETES AND MORBID OBESITY, WHICH ARE SPECIFICALLY KNOWN TO BE ASSOCIATED WITH AN INCREASED RISK FOR ANASTOMOTIC FAILURE. YET, THE CURRENT CUMULATIVE LEAKAGE AND MORTALITY RATE FOUND WITH THE USE OF THE COLONRING IS WITHIN THE LOW RANGE REPORTED FOR ANASTOMOSIS DEVICES.

    Description of Event or Problem · 1

    THE PT UNDERWENT A LAPAROSCOPIC SIGMOID RESECTION PROCEDURE WITH MOBILIZED SPLENIC FLEXURE DUE TO DIVERTICULITIS WITH COLOVESICAL AND COLOVAGINAL FISTULAS. THE ANASTOMOSIS WAS PERFORMED WITH THE COLONRING DEVICE WITH NEGATIVE BUBBLE TEST. IT WAS REPORTED THAT THE PT DIED ON POD #8. ACCORDING TO THE SURGEON: "THE PT WAS A HIGH RISK PT (CONSIDERATION WAS GIVEN TO HOSPICE RATHER THAN HAVING THE SURGERY). SHE DID DEVELOP AND INTRA-ABDOMINAL INFECTION, AND THIS COULD HAVE BEEN AN ANASTOMOTIC LEAK, BUT SHE WAS NOT RE-EXPLORED, SO DO NOT KNOW FOR SURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114509 COLONRING/COMPRESSION ANASTOMOSIS RING (CAR27) IMPLANTABLE CLIP (FZP) FZP NOVOGI LTD. COLONRING (CAR27) 43271253

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death