BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION

    MDR report key: 7111905 · Received December 13, 2017

    Report

    Report Number
    3002808486-2017-02417
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    November 17, 2017
    Report Date
    March 13, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526553
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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). 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) P070016. (B)(4). INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE GRAFT WAS BEING IMPLANTED INTO THE ASCENDING THORACIC AORTA AND WAS DEPLOYED AS PER INSTRUCTIONS. WHEN THE PHYSICIAN WENT TO REMOVE THE SAFETY WIRE TO RELEASE THE GRAFT FROM THE DELIVERY SYSTEM, HE COULDN'T REMOVE IT AT ALL EVEN AFTER 10-MINS OF VERY FORCEFUL PULLING. THE PULLING WAS INVERTING THE GRAFT AS THE SAFETY WIRE JUST WOULDN'T RELEASE. PATIENT OUTCOME: THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE - THE PATIENT HAD TO UNDERGO AN OPEN PROCEDURE TO REMOVE THE DELIVERY SYSTEM AS IT COULDN'T BE REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE - MUCH LONGER RECOVERY TIME FROM THE PROCEDURE, LONGER STAY IN ICU.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE COMPLAINT CONCERNS A PATIENT WHO UNDERWENT A TEVAR WITH A TX2. THE PHYSICIAN DEPLOYED THE STENT GRAFT BUT EXPERIENCED DIFFICULTY WITH REMOVING THE TRIGGER WIRES. AFTER 10 MINUTES OF FORCEFUL PULLING, THE STENT GRAFT WAS INVERTED AND THE PATIENT UNDERWENT OPEN SURGERY TO REMOVE THE STENT GRAFT AND INTRODUCTION SYSTEM. THE DEVICE WAS RETURNED WITH AN INNER SYSTEM CUT IN TWO PIECES. THE STENT GRAFT WAS STILL ATTACHED TO THE DILATOR TIP AND THE WIRE-GUIDE WAS STILL INSIDE THE INTRODUCTION SYSTEM. THE DEVICE EXAMINATION IDENTIFIED A GREEN TRIGGER-WIRE KNOB THAT WAS WITHDRAWN ~1 CENTIMETER AND ROTATED HALF A TURN. THE GREEN KNOB WAS THEREAFTER SEPARATED FROM THE HANDLE FOR FURTHER INVESTIGATION OF THIS PART OF THE DEVICE. IT SHOWED THAT THE WIRES HAD BEEN ROTATED IN THE SAME DIRECTION AS THE GREEN KNOB, WHICH REFLECTED THE OBSERVED ROTATION OF THE GREEN KNOB PRIOR TO SEPARATION. THIS MAY LIKELY HAVE CAUSED THE WIRES TO BE CAUGHT BETWEEN THE HANDLE AND THE GREEN KNOB AND THEREBY LOCKING THE GREEN TRIGGER-WIRE RELEASE MECHANISM. THE HANDLE AND THE INNER SIDE OF THE GREEN KNOB WAS INVESTIGATED UNDER LIGHT MICROSCOPY AND SEVERAL WIRE-MARKS, IN THE ROTATION DIRECTION, WERE IDENTIFIED ON BOTH PARTS. AS PER IFU, ROTATION OF THE GREEN TRIGGER-WIRE KNOB WHILE WITHDRAWING THE TRIGGER-WIRES ARE NOT RECOMMEND (12. LOOSEN THE SAFETY LOCK FROM THE GREEN TRIGGER-WIRE RELEASE MECHANISM. WITHDRAW THE TRIGGER-WIRE IN A CONTINUOUS MOVEMENT UNTIL THE PROXIMAL END OF THE GRAFT OPENS. DO NOT ROTATE THE GREEN TRIGGER-WIRE KNOB. WITHDRAW THE TRIGGER-WIRE COMPLETELY TO RELEASE THE DISTAL ATTACHMENT TO THE INTRODUCER.). FURTHERMORE, REVIEW OF THE IMAGING FOUND THAT THE DEPLOYMENT WAS ATTEMPTED IN THE ASCENDING AORTA JUST PROXIMAL TO THE AORTIC ARCH. REFERRING TO THE IFU, THE DEVICE IS ONLY INTENDED FOR TREATMENT IN THE DESCENDING AORTA (2 INTENDED USE. THE ZENITH TX2 TAA ENDOVASCULAR GRAFT WITH PRO-FORM WITH THE Z-TRAK PLUS INTRODUCTION SYSTEM IS INTENDED FOR TREATMENT OF PATIENTS WITH ARTHEROSCLEROTIC ANEURYSMS, SYMPTOMATIC ACUTE OR CHRONIC DISSECTIONS, CONTAINED RUPTURES, GROWING ANEURYSMS AND/OR RESULTING IN DISTAL ISCHEMIA, IN THE DESCENDING THORACIC AORTA.). BASED ON THE ABOVE INFORMATION, THE LIKELY CAUSE FOR THE EVENT IS ROTATION OF THE GREEN TRIGGER-WIRE KNOB. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. INITIAL REPORTER WILL BE INFORMED OF THE RESULT OF THE INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895075 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526553

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R