BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPRESSION ANASTOMOSIS RING (CAR 27)

    MDR report key: 1833055 · Received September 7, 2010

    Report

    Report Number
    3005278776-2010-00127
    Event Type
    Death
    Date Received
    September 7, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 9, 2010
    Manufacturer
    NITI SURGICAL SOLUTIONS LTD.
    Product Code
    FZP
    PMA / PMN Number
    K062008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVAL, HOWEVER, THE PRODUCTION HISTORY FILES WERE REVIEWED, INDICATING THAT THE DEVICE WAS RELEASED ACCORDING TO THE PRODUCT SPECIFICATIONS. THE PT SUFFERED FROM MULTIPLE MEDICAL CONDITIONS AND WAS CHRONICALLY TREATED WITH COUMADIN DUE TO VALVULAR DISEASE. THE PT UNDERWENT AN EXTENSIVE SURGICAL GASTROINTESTINAL AND GENITOURINARY PROCEDURE WITH POST SURGICAL DETERIORATION, WHICH INCLUDED BLEEDING AND RESPIRATORY FAILURE WITH ASPIRATION DURING INTUBATION. ACCORDING TO THE SURGEON AND POST SURGICAL CONSULTATION REPORTS, THE RESPIRATORY FAILURE MAY HAVE BEEN ASSOCIATED WITH A PULMONARY EMBOLI OR VOLUME OVERLOAD. NO ANASTOMOTIC OR ANY DEVICE RELATED COMPLICATIONS WERE REPORTED IN RELATION TO THIS OUTCOME DURING THE SURGERY AND IN THE POST OPERATIVE PERIOD. THE SURGEON CLAIMS THE DEATH IS NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    THE PT UNDERWENT EXTENSIVE ABDOMINAL AND PELVIC SURGERY, WHICH INCLUDED A SIGMOID RESECTION DUE TO RECTAL PROLAPSE AND TAH/BSO, CYSTOSCOPY AND BLADDER BOTOX. POST OPERATIVELY THE PT SUFFERED FROM SYMPTOMATIC ANEMIA POSSIBLY DUE TO UPPER GASTROINTESTINAL TRACT BLEEDING MANIFESTED AS HEMATEMESIS AND MELENA AND VAGINAL BLEEDING, WITH A REDUCTION OF HEMOGLOBIN FROM 13 TO 5.2 (SHE HAS REC'D MULTIPLE PACKED RED BLOOD CELL TRANSFUSIONS AND THE HEMOGLOBIN WENT UP TO 9 GRAMS, AND AGAIN TO 5.2). SHE DEVELOPED A HEART/RESPIRATORY DISTRESS. ON POSTOPERATIVE DAY 6 SHE WENT INTO CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSION ANASTOMOSIS RING (CAR 27) IMPLANTABLE CLIP (FZP) FZP NITI SURGICAL SOLUTIONS LTD. CAR 27 43001004

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death