BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 6756271 · Received August 1, 2017

    Report

    Report Number
    2953200-2017-01200
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    August 24, 2016
    Report Date
    July 12, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE: ¿EARLY- AND MID-TERM RESULTS OF THE CHIMNEY TECHNIQUE IN THE REPAIR OF AORTIC ARCH PATHOLOGIES.¿ JUNJIE ZOU, YUANYONG JIAO, XIWEI ZHANG, JUN JIANG, HONGYU YANG, HAO MA1 (CARDIOVASC INTERVENT RADIOL (2016) 39:1550¿1556) CARDIOVASC INTERVENT RADIOL (2016) 39:1550¿1556 DOI 10.1007/S00270-016-1439-6.

    Description of Event or Problem · 1

    THE FOLLOWING ADVERSE EVENTS AND PRODUCT PROBLEMS WERE REPORTED: FEMORAL ARTERY DISSECTION, CHIMNEY MIGRATION. ABSTRACT PURPOSE TO EXAMINE THE SAFETY, FEASIBILITY, AND MID-TERM EFFICACY OF THE CHIMNEY TECHNIQUE FOR AORTIC ARCH PATHOLOGIES. METHODS FROM FEBRUARY 2011 TO DECEMBER 2014, A TOTAL OF 35 PATIENTS (30 MEN; MEAN AGE 54.3 ± 14.1 YEARS) WITH AORTIC ARCH PATHOLOGIES UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR COMBINED WITH CHIMNEY STENTS. THE INDICATION WAS A PROXIMAL LANDING ZONE \1.5 CM. FOLLOW-UP WAS PERFORMED AT 3, 6, AND 12 MONTHS AND THEN YEARLY THEREAFTER. RESULTS A TOTAL OF 36 CHIMNEY STENTS WERE DEPLOYED (INNOMINATE ARTERY, N = 1; LEFT COMMON CAROTID ARTERY, N = 9; RIGHT SUBCLAVIAN ARTERY, N = 1; LEFT SUBCLAVIAN ARTERY, N = 25). THE TECHNICAL SUCCESS RATE WAS 94.3 % (33/35). IMMEDIATE TYPE IA ENDOLEAKS (ELIA) WERE OBSERVED IN TWO PATIENTS (8.6 %, 2/35). TWENTY-FIVE PATIENTS WERE SUCCESSFULLY FOLLOWED-UP FOR A MEDIAN PERIOD OF 29.3 MONTHS (RANGE, 6¿48 MONTHS). ONE PATIENT DIED DUE TO AORTIC DISSECTION ANEURYSM RUPTURE AT 36 MONTHS (MORTALITY RATE OF 4 %, 1/25). THREE LATE ELIA WERE OBSERVED AND NO REINTERVENTIONS WERE PERFORMED. THE OVERALL INCIDENCE OF ELIA WAS 20 % (5/25). DURING FOLLOW-UP, THE PATENCY RATE FOR CHIMNEY STENTS WAS 92 % (23/25). CONCLUSION OUR LIMITED EXPERIENCE DEMONSTRATES THAT THE FOR PATIENTS WITH CHALLENGING THORACIC AORTIC PATHOLOGIES AT LEAST IN THE MID-TERM FOLLOW-UP PERIOD. CHIMNEY TECHNIQUE IS A VIABLE AND RELATIVELY SAFE TREATMENT. THE EXACT CAUSE OF THE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED FROM THE POST-IMPLANT FILMS PROVIDED. PRE-IMPLANT ANATOMY INFORMATION, FILMS AT IMPLANT, AND EARLIER POST-IMPLANT FILMS WERE NOT RETURNED FOR REVIEW AND COMPARISON. HOWEVER, THE POST-IMPLANT FILMS PROVIDED SHOWED THAT THERE WAS NO RADIAL APPOSITION BETWEEN THE DISTAL RIGHT/IPSI LIMB AND THE VESSEL WALL. THE RIGHT COMMON ILIAC ARTERY SURROUNDING THE RIGHT/IPSI LIMB HAD DILATED BEYOND THE NOMINAL DIAMETER OF THE IPSI LIMB. CONTRAST WAS SEEN OUTSIDE OF THE ISPI LIMB, BUT THE CONTRAST DID NOT APPEAR TO BE FEEDING THE ANEURYSM SAC DESPITE LACK OF SEAL. IT IS POSSIBLE THAT THERE WAS DISEASE PROGRESSION OF VESSEL DILATION IN THE RIGHT COMMON ILIAC ARTERY, WHICH CONTRIBUTED TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537571 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention