BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1445438 · Received August 19, 2009

    Report

    Report Number
    1820334-2009-00463
    Event Type
    Injury
    Date Received
    August 19, 2009
    Date of Event
    July 15, 2009
    Report Date
    July 20, 2009
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAPTOR SHEATH ASSEMBLY WAS RECEIVED IN A USED AND CONTAMINATED CONDITION. THE DEVICE HAD BEEN DECONTAMINATED BY COOK INC. PRIOR TO THIS EXAMINATION. THE VRTS SHEATH HAD BEEN KINKED IN SEVERAL LOCATIONS THROUGHOUT THE LENGTH OF THE DEVICE. THIS WAS LIKELY DUE TO THE UNSUPPORTED INNER LUMEN DURING TRANSPORT BACK TO COOK INC. THE VALVE CONTROL WAS IN MID-RANGE; THE ARROW WAS LOCATED BETWEEN THE FULLY OPEN AND FULLY CLOSED POSITION. FROM THE DISTAL END LOOKING INTO THE VALVE, IT COULD BE SEEN THE DISTAL FLANGE ON THE IRIS VALVE HAD BEEN PULLED AWAY FROM ITS NORMAL POSITION. IT WAS VISUALLY VERIFIED WHEN THE VALVE CONTROL WAS ROTATED, THE IRIS VALVE REMAINED STATIONARY. THERE WAS NO INDICATION THAT THE VALVE CONTROL HAD BEEN OVER ROTATED. DURING THE EXAMINATION, THE CAPTOR VALVE SLEEVE HAD COME APART FROM THE CAPTOR VALVE ASSEMBLY. EACH DEVICE IS INSPECTED FOR THE FOLLOWING PRIOR TO SHIPPING: THE VALVE CONTROL CAP IS VERIFIED TO BE COMPLETELY SNAPPED INTO THE VALVE CONTROL. WHEN IN THE OPEN POSITION THE LUMEN OF THE VALVE IS CONFIRMED TO BE OPEN. A LEAK TEST IS PERFORMED ON THE CAPTOR VALVE ASSEMBLY. THE VALVE CONTROL IS ROTATED VERIFYING THE IRIS VALVE CLOSES WHEN IN THE CLOSED POSITION. ALSO FOR: THE CORRECT CAPTOR VALVE SLEEVE IS VERIFIED TO HAVE BEEN USED AND VERIFIED TO BE SECURELY ATTACHED TO THE CAPTOR VALVE ASSEMBLY AND SHEATH. DESIGN CONTROLS: EXAMINATION OF DISLODGEMENT OF SEALS FOR Z-TRAK CAPTOR VALVE ASSEMBLIES. EACH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) IFU DESCRIBING THE APPROPRIATE WARNINGS & PRECAUTIONS, CONTRAINDICATIONS, AND THE PROPER DEPLOYMENT PROCEDURE. IT IS SPECULATED THE LOOSE FLANGE FROM THE IRIS VALVE IS THE SPECIFIC MALFUNCTION THE PHYSICIAN EXPERIENCED. THE PROVIDED EVENT DESCRIPTION WAS INITIALLY UNCLEAR AS TO THE EXACT PROBLEM THE USER EXPERIENCED. THE EVENT DESCRIPTION STATES "AS THE SHEATH WAS PULLED BACK IN DEPLOYMENT, THE HEMOSTATIC VALVE CAME APART IN THE CLINICIAN'S HANDS". IT IS SPECULATED AT THIS TIME THE VALVE WAS PARTIALLY, OR FULLY CLOSED WHEN THE USER BEGAN TO PULL BACK THE SHEATH. THIS WOULD INCREASE THE AMOUNT OF FORCE TO PULL BACK THE SHEATH OVER THE GREY POSITIONER, AND SPECIFICALLY, TRANSFER THIS FORCE TO THE COMPRESSED DISTAL FLANGE OF THE IRIS VALVE. THIS COULD RESULT IN THE EFFECTS EXPERIENCED BY THIS USER. IT IS UNKNOWN AT THIS TIME WHEN AND IF THIS EVENT CONTRIBUTED TO THE COMPROMISED CAPTOR VALVE SLEEVE CONNECTION TO THE CAPTOR VALVE ASSEMBLY. AT THIS TIME A DEFINITIVE ROOT CAUSE CANNOT BE REPORTED, HOWEVER, IT IS SPECULATED TO BE USER ERROR. WE WILL CONTINUE TO MONITOR FOR SIMILAR INCIDENTS.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT ENDOVASCULAR THERAPY IN 2009. AS THE SHEATH WAS PULLED BACK IN DEPLOYMENT, THE HEMOSTATIC VALVE CAME APART IN THE CLINICIAN'S HANDS. AS A RESULT, THERE WAS SUFFICIENT BLOOD LOSS AS THE BLOOD COULDN'T BEEN COLLECTED IN THE VALVE. DEPLOYMENT SEQUENCE WAS CONTINUED AND THE STENT GRAFT WAS DEPLOYED CORRECTLY. SHORT TERM ADVERSE EFFECT FROM THE INCREASED BLOOD LOSS DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA 2266221

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other