BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4636954 · Received March 26, 2015

    Report

    Report Number
    2953200-2015-00579
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    January 3, 2014
    Report Date
    March 3, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OFF LABEL: IMPLANTED TO TREAT AORTIC ARCH ANEURYSM, AORTIC ARCH COARCTATION AND LICA ANEURYSM.

    Description of Event or Problem · 1

    PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO A UNITED STATES DISTRIBUTED PRODUCT. WEIMIN ZHOU*, WEI ZHOU, JIEHUA QIU AND QINGZHONG ZENG, HYBRID PROCEDURE TO TREAT AORTIC ARCH ANEURYSM COMBINED WITH AORTIC ARCH COARCTATION AND LEFT INTERNAL CAROTID ARTERY ANEURYSM (CASE REPORT) HTTP://WWW.CARDIOTHORACICSURGERY.ORG/CONTENT/9/1/3 ON UNKNOWN DATES, A VALIANT STENT GRAFT WAS IMPLANTED TO TREAT AORTIC ARCH ANEURYSM, AORTIC ARCH COARCTATION AND LICA ANEURYSM. A 50 MM SIZED SACCULAR ANEURYSM WAS MEASURED 3 MM DISTAL TO THE LEFT COMMON CAROTID ARTERY (LCCA), THE LEFT SUBCLAVIAN ARTERY (LSA) AROSE FROM THE AORTIC ARCH ANEURYSM AND THE SIZE OF AORTIC ARCH COARCTATION WAS 12MM. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: UNABLE TO DEPLOY STENT GRAFT, INTERVENTION WHERE THE RIGHT BRACHIAL ARTERY WAS PUNCTURED AND CANNULATED, AORTIC ARCH ANEURYSM SAC THROMBOSIS, TYPE I ENDOLEAK, MILD STENOSIS OF LICA AND AORTIC ARCH. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. ABSTRACT AORTIC ARCH ANEURYSM IS A RARE CONDITION BUT CARRIES A HIGH RISK OF RUPTURE. WE REPORT ONE CASE OF AORTIC ARCH ANEURYSM COMBINED WITH AORTIC ARCH COARCTATION AND LEFT INTERNAL CAROTID ARTERY ANEURYSM, WHICH IS EXTREMELY RARE. LEFT INTERNAL CAROTID ARTERY ANEURYSM RESECTION AND REVASCULARIZATION, CAROTID AND CAROTID GRAFT BYPASS COMBINED WITH ENDOVASCULAR STENT GRAFT AND EMBOLIZATION WITH COILS WERE SUCCESSFULLY PERFORMED. THERE WERE NO ANY COMPLAINTS AND COMPLICATIONS AT 8 MONTHS FOLLOW-UP. THE FOLLOW-UP CTA DEMONSTRATED THROMBUS FORMATION IN THE ANEURYSM LUMEN, NO ENDOLEAK AND THE AORTIC ARCH AND BYPASS GRAFT WERE ALL PATENT. WE FEEL THAT HYBRID PROCEDURE MAY BE A VALUABLE THERAPEUTIC ALTERNATIVE WHEN TREATING THIS TYPE OF LESION. HOWEVER, LONG-TERM CLINICAL EFFICACY AND SAFETY HAVE YET TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203180 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention