BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 6039425 · Received October 19, 2016

    Report

    Report Number
    1820334-2016-01058
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 21, 2016
    Report Date
    July 20, 2017
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002552385
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED DAMAGE TO THE INNER CANNULA, BENT MORE THAN 45 DEGREES NEAR THE HUB. THE DILATOR APPEARED SLIGHTLY FORWARD. THE SHEATH TIP IS FOLDED INWARD AND WRINKLED. IN ADDITION, THE GRAFT MATERIAL OF THE DEVICE WAS VISIBLE AT THE TIP OF THE SHEATH. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER DUE TO THE PRODUCT ONLY HAVING ONE PER LOT. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE. IMPLANT PROCEDURE: ¿DO NOT CONTINUE ADVANCING ANY PORTION OF THE DELIVERY SYSTEM IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE WIRE GUIDE OR DELIVERY SYSTEM. STOP AND ASSESS THE CAUSE OF RESISTANCE; VESSEL, CATHETER OR GRAFT DAMAGE MAY OCCUR. EXERCISE PARTICULAR CARE IN AREAS OF STENOSIS, INTRAVASCULAR THROMBOSIS, OR IN CALCIFIED OR TORTUOUS VESSELS.¿ UPON INSPECTION THE INNER CANNULA WAS NOTED TO BE BENT AND THE DILATOR TIP PUSHED FORWARD. THE WRINKLING OF THE SHEATH OBSERVED BY THE PHYSICIAN LIKELY OCCURRED DUE TO A LACK OF SUPPORT FROM THE DILATOR TIP, BECAUSE THE TIP WAS PUSHED FORWARD RELATIVE TO THE SHEATH DURING ADVANCEMENT. BASED ON THE INFORMATION PROVIDED AND RESULTS OF THE INVESTIGATION THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT MAY BE RELATED TO USER TECHNIQUE. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE.

    Description of Event or Problem · 1

    A PATIENT OF UNKNOWN GENDER AND AGE WAS UNDERGOING A PROCEDURE TO PLACE AN ENDOVASCULAR GRAFT. WHILE ATTEMPTING TO INTRODUCE THE DEVICE PERCUTANEOUSLY, THE PHYSICIAN WAS NOT ABLE TO ADVANCE THROUGH THE SKIN AS THE SHEATH WAS WRINKLED AND BUNCHING ON THE SKIN. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE WITH NO HARM TO THE PATIENT AND NO FURTHER COMPLICATIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. 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
    690569 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A 10827002552385

    Patients

    Seq Age Sex Outcome Treatment
    1