BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 6998564 · Received November 3, 2017

    Report

    Report Number
    3002808486-2017-02179
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    June 30, 2017
    Report Date
    January 15, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002346731
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION OF THIS COMPLAINT WAS BASED ON DESCRIPTION OF EVENT AND IMAGING REVIEW. THIS COMPLAINT CONCERNS A PATIENT TREATED WITH AN ALPHA GRAFT FOR AORTIC COARCTATION. THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS AND ULCERS OF THE DESCENDING THORACIC AORTA. THUS, THE ALPHA GRAFT WAS USED OUTSIDE OF IFU INDICATIONS, WHICH WAS ALSO STATED IN THE EVENT DESCRIPTION. ACCORDING TO IMAGING REVIEW APPROXIMATELY 1 YEAR POSTOPERATIVELY, THE PATIENT DEVELOPED GRAFT STENOSIS AND THROMBOSIS AND IS TREATED SUCCESSFULLY WITH THROMBOLYSIS, ANGIOPLASTY, AND RELINING OF THE THORACIC STENT GRAFT DEVICE WITH AN AORTIC STENT. THE AORTIC ARCH APPEARS TO HAVE A NARROW RADIUS RESULTING IN A PERPENDICULAR POSITION OF THE PROXIMAL STENT GRAFT TO THE LUMEN OF THE ASCENDING AORTA. IT CANNOT BE DETERMINED IF THIS ARCH ANATOMY CONTRIBUTED TO THE GRAFT THROMBOSIS. THE GRAFT THROMBOSIS REPRESENTS A CLINICAL FINDING RELATED TO THE PERFORMANCE OF THE DEVICE. THE CAUSE OF THE THROMBOSIS, HOWEVER, CANNOT BE DETERMINED FROM THE IMAGES PROVIDED. AS PER IFU ARTERIAL THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENTS. ADDITIONAL SURVEILLANCE AND POSSIBLE TREATMENT IS RECOMMENDED FOR THIS EVENT. NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    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) P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "ON (B)(6) 2016 WE DID A TEVAR FOR AN AORTIC COARCTATION, IN A YOUNG PATIENT WITH A NARROW AORTA. FOR THIS PARTICULAR CASE, WE SELECTED A ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT. THE SURGERY WAS STRAIGHT, WITHOUT INTRAOPERATIVE COMPLICATIONS, AND THE PATIENT WAS DISCHARGED AFTER 48 HOURS. ALL THE PERIPHERAL PULSES WERE NORMAL AT THAT TIME. ON (B)(6) 2017 THIS PATIENT WAS ADMITTED AT AN EMERGENCY ROOM, WITH EXTREME LOWER LIMBS FATIGUE AND WEAK FEMORAL PULSE. CTA DEMONSTRATED STENOSIS AT THE GRAFT EDGES WITH ASSOCIATED THROMBUS ALONG ALL THE ZENITH ALPHA THORACIC. ON (B)(6) 2017 A NEW PROCEDURE WAS DONE TO FIX THE PROBLEM. AFTER AN INTRA-ARTERIAL INFUSION OF R-TPA, WE IMPLANTED AN AORTIC STENT JOTEC E-XL, DOING A DILATATION OG THE UNDERLYING STENOSIS. ALL THE ZENITH GRAFT WAS COVERED WITH THE JOTEC STENT. . PATIENT OUTCOME: THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. - IMPLANTED AN AORTIC STENT ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID EXPERIENCE EXTREME LOWER LIMBS FATIGUE AND WEAK FEMORAL PULSE DUE TO THIS OCCURRENCE. THE PATIENT WAS DISCHARGED AFTER 7 DAYS AND REMAINING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780515 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002346731

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R