BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 3731559 · Received March 27, 2014

    Report

    Report Number
    1820334-2014-00134
    Event Type
    Injury
    Date Received
    March 27, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    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

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6)-YEAR-OLD PT UNDERWENT AAA REPAIR WITH RIGHT APPROACH ON (B)(6) 2013. SIZING/PLANNING INFO: D1: 25-26MM, D3: 13MM, L1: 133MM, L3: 178MM. THERE WAS SEVERE CALCIFICATION IN THE ACCESS ROUTE REGIONALLY AND VESSEL DIAMETER OF THE ACCESS ROUTE WAS APPROXIMATELY 7MM. THE PHYSICIAN JUDGE THAT THE PT WAS SUITABLE FOR THE ENDOVASCULAR REPAIR. THE PROCEDURE WAS SCHEDULED AS FOLLOWS: MAINBODY - CONVERTER - IPSILATERAL ILIAC LEG PLACEMENT. ALTHOUGH THE PHYSICIAN HAD DIFFICULTY IN ADVANCING DELIVERY SYSTEM OF MAINBODY, THE STENT GRAFT OF MAINBODY WAS PLACED AS PLANNED. THEN, DELIVERY SYSTEM OF CONVERTER WAS INSERTED . DURING ADVANCEMENT, THE DELIVERY SYSTEM WAS CAUGHT ON NEAR BIFURCATION AREA AND STOPPED ADVANCING. PULL-THROUGH TECHNIQUE WAS PERFORMED BUT IT DID NOT SUPPORT ADVANCEMENT. SINCE THE DELIVERY SYSTEM WOULD NOT ADVANCED DESPITE FORCIBLE ATTEMPTS OF ADVANCEMENT, THE PHYSICIAN DECIDED TO STOP USING THE DEVICE. WHEN THE USER REMOVED THE DELIVERY SYSTEM, HE NOTICED THAT THE INNER CANNULA WAS BROKEN AT APPROX 5CM BELOW THE DILATOR TIP AND THE DILATOR TIP WITH THE APPROX 5CM OF THE INNER CANNULA REMAINED INSIDE THE PT OVER A WIRE GUIDE. THEN, THE USER PULLED THE WIRE GUIDE IN ORDER TO RETRIEVE THE REMAINED DILATOR TIP WITH APPROX 5CM OF THE INNER CANNULA, AND FINALLY THE REMAINED SECTION WAS SUCCESSFULLY RETRIEVED WITH FORCEPS. VASCULAR PROSTHESIS WAS ATTACHED SINCE APPROACHING SITE WAS CHANGED TO THE RIGHT CIA, THEN SAME-SIZED BACK-UP DEVICE WAS ADVANCED THROUGH THE VASCULAR PROSTHESIS INSTEAD. ALTHOUGH IT WAS ALSO DIFFICULT TO ADVANCED THE DELIVERY SYSTEM, THE CONVERTER WAS PLACED IN THE DESIRED SITE AND ILIAC LEG GRAFT WAS PLACED AS PLANNED TOO. THE PROCEDURE WAS FINISHED AFTER ANGIOGRAPHY CONFIRMED NO ENDOLEAK, AND THE PT LEFT THE OPERATION ROOM AFTER CLOSING SURGICAL INCISION. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179589 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 4461333

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention