BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6633003 · Received June 12, 2017

    Report

    Report Number
    3002808486-2017-01258
    Event Type
    Injury
    Date Received
    June 12, 2017
    Report Date
    May 18, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). D4) CATALOG#: UNKNOWN BUT REFERRED TO AS A ZTA-D DEVICE G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113 G5) SIMILAR TO DEVICE UNDER 510(K): P140016. (B)(4).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: THE DISTAL BARE STENT WAS RELEASED IN A HIGHLY ANGULATED AND FUNNELED DISTAL THORACIC AORTA AS IT ENTERED THE ABDOMEN THROUGH THE DIAPHRAGMATIC CRUS. RELEASE DIFFICULTIES WITH GREATER THAN 45 DEGREES OF ANGULATION ARE NOTED IN THE IFU. THE REPORTED DIFFICULTY PULLING BACK THE BLACK HANDGRIP IS CONSISTENT WITH BARE STENT ENTRAPMENT IN THE DISTAL CAP. GIVEN THE ANGULATION AND RELATIVE STENOSIS, A BARB WAS LIKELY PERCHED IN THE CAP HOLE AS DESCRIBED IN THE IFU. NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DESCRIPTION ACCORDING TO INITIAL REPORTER: DURING DEPLOYMENT OF DISTAL COMPONENT, IT WAS DIFFICULT TO PULL BACK THE BLACK SLIDING PART SO THE BARE STENT WAS NOT RELEASED. AS THE BLACK SLIDING PART DID NOT CLICK WITH THE HANDLE, STEP 3 COULDN`T BE PERFORMED. THE BAIL OUT PROCEDURE WAS PERFORMED AND THE BARE STENT WAS RELEASED. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414942 UNKNOWN MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening