BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1665057 · Received April 20, 2010

    Report

    Report Number
    1820334-2010-00213
    Event Type
    Injury
    Date Received
    April 20, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 22, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE UNKNOWN AS LOT IS UNKNOWN. (B) (4). THE ZENITH DEVICE HAS COMPLETED REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECT; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, PROPER BALLOONING SITES, THE IMPORTANCE OF AN ACCURATE DEPLOYMENT. THE DATE OF THE INITIAL REPAIR AND THE ENDOGRAFT USED ARE UNKNOWN. SECONDARY PROCEDURE WAS PERFORMED (B) (6)2010 TO RESOLVE A PERSISTENT TYPE 1A. TWO ZENITH MAIN BODY EXTENSIONS WERE DEPLOYED. THE ENDOLEAK WAS SLOWED, BUT NOT RESOLVED. THE COMPLAINT CORRESPONDENCE INDICATED THAT ADDITIONAL EXTENSIONS WERE NOT PLACED DUE TO LACK OF LANDING/SEALING AREA. WITHOUT IMAGES OR ADDITIONAL INFORMATION, WE ARE UNABLE TO COMMENT ON THE PATIENT'S SUITABILITY FOR EVAR OR OPEN REPAIR, OR POSSIBLE CONTRIBUTING FACTORS TO THE ENDOLEAK. WE WILL NOTIFY THE APPROPRIATE IN-HOUSE PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A (B) (6) FEMALE PATIENT WHO HAD PREVIOUSLY UNDERWENT AAA REPAIR, UNDERWENT A SECONDARY REPAIR ON (B) (6) 2010. THE PHYSICIAN CONTACTED THE SALES REPRESENTATIVE THE MORNING OF (B) (6) 2010, IN REGARDS TO A REOCCURRING TYPE I ENDOLEAK ON HIS PATIENT. HE ASKED THAT THE SALES REPRESENTATIVE BE PRESENT AT THE CASE WITH A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION DEVICE TO COVER THE ENDOLEAK. DURING THE PROCEDURE, THE PHYSICIAN STARTED BY FILLING THE ANEURYSM SAC WITH 20 OR SO COILS AND FOLLOWED WITH PLACEMENT OF THE ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION. THE LEAK DID NOT COMPLETELY SUBSIDE, BUT WAS SLOWED. THE PHYSICIAN DECIDED NOT TO ADD ANOTHER ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION DUE TO THE LACK OF LANDING/SEAL AREA. PATIENT MAY NEED FURTHER TREATMENT DUE TO THE FACT THAT THE ENDOLEAK WAS NOT COMPLETELY DISSOLVED. THIS IS AT THE PHYSICIANS DISCRETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention