BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 3170421 · Received June 7, 2013

    Report

    Report Number
    1820334-2013-00261
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVAL: THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS FOR 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 TRACKABILITY OF THE DEVICE, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS, SPECIFICALLY STATING: "ADEQUATE ILIAC OR FEMORAL ACCESS IS REQUIRED TO INTRODUCE THE DEVICE INTO THE MORPHOLOGY (MINIMAL TORTUOSITY, OCCLUSIVE DISEASE AND/OR CALCIFICATION) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEMS OF A 16 FRENCH TO 22 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS." "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." PRODUCT WAS NOT RETURNED TO ASSIST IN THE INVESTIGATION. THE INFO AVAILABLE IN THE COMPLAINT FILE, THE PHYSICIAN'S COMMENTS REGARDING THE CASE, THE DEVICE IFU, APPLICABLE QERA, AND COMPLAINT HISTORY WERE REVIEWED AS PART OF THE INVESTIGATION. THE EVENT WAS TRENDED AS RESULTING IN MODERATE HARM TO THE PATIENT, DUE TO THE ADD'L INTERVENTION USED DURING THE PROCEDURE. IT IS LIKELY THAT PATIENT ANATOMY WAS A CONTRIBUTING FACTOR TO THIS EVENT, AND NOT A FAILURE OF THE DESIGN OR FUNCTION OF THE DEVICE. THE PHYSICIAN IS QUOTED AS STATING: " ABOUT TFLE, I PUSHED IT PRETTY HARD BECAUSE THE VESSEL WAS HIGHLY CALCIFIED AND IT COULD TURN THE SHEATH OUTWARD. ABOUT TFLE, I THINK IT GOT CAUGHT IN THE MAIN BODY BECAUSE I COULD ADVANCE THE MAIN BODY WHICH WAS BIGGER THAN THE LEG." THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT (QERA) AND THE RISK REMAINS AT AN ACCEPTABLE LEVEL WITH THE INCLUSION OF THIS EVENT. NO ADD'L RISK REDUCTION ACTIVITIES ARE REQUIRED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A (B)(6) MALE PATIENT UNDERWENT EVAR. THE PATIENT'S ANATOMY WAS TORTUOUS AND HIGHLY CALCIFIED. AFTER PLACEMENT OF MAIN BODY APPROACHED FROM THE RIGHT FEMORAL, THE PHYSICIAN INSERTED A FLEX ILIAC LEG GRAFT FROM THE LEFT AND ATTEMPTED TO ADVANCE TO THE TARGET SITE, BUT IT WOULD NOT PASS THE COMMON ILIAC ARTERY. HE TRIED MANY TIMES, BUT FAILED, SO HE INSERTED A 18FR SHEATH FOR MORE SUPPORT AND TRIED AGAIN, HOWEVER THE STENT GRAFT CAME OUT OF SHEATH (1820334-2013-00261). HE REMOVED IT AND TOOK PULL-THROUGH TECHNIQUE FROM THE LEFT ARM. HE INSERTED ANOTHER ILIAC LEG GRAFT AND SUCCEEDED TO ADVANCE IT AND PLACED THE ILIAC LEG GRAFT AT THE TARGET SITE. HE PLACED ANOTHER ILIAC LEG GRAFT IN THE LEFT, THEN INSERTED A 4TH FROM THE RIGHT AND ATTEMPTED TO ADVANCE; IT WOULD NOT PASS THE COMMON ILIAC ARTERY AS WELL. THE DELIVERY SYSTEM TIP GOT BENT BECAUSE IT GOT CAUGHT IN THE DISTAL SIDE OF MAIN BODY DUE TO PUSHING TOO HARD. HE REMOVED IT AND TOOK PULL-THROUGH TECHNIQUE FROM THE LEFT ARM. HE INSERTED ANOTHER ILIAC LEG GRAFT AND SUCCEEDED TO ADVANCE IT AND PLACED THE ILIAC LEG GRAFT AT THE TARGET SITE. PROXIMAL TYPE I ENDOLEAK AND DISTAL TYPE I ENDOLEAK WERE CONFIRMED BY CONFIRMATORY ANGIOGRAPHY (1820334-2013-00137). A MAIN BODY EXTENSION WAS ADDITIONALLY PLACED FOR PROXIMAL TYPE I ENDOLEAK BUT THE LEAK PERSISTED. ONLY ADD'L BALLOONING WAS PERFORMED FOR DISTAL TYPE I ENDOLEAK BECAUSE OCCLUSION OF THE INTERNAL ILIAC ARTERY WAS NOT PLANNED. THE LEAK PERSISTED. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH AND COMPLETED THE PROCEDURE. THE PATIENT IS DOING FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253400 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2750018

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R