BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4100245 · Received September 18, 2014

    Report

    Report Number
    2953200-2014-01865
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    March 29, 2014
    Report Date
    August 26, 2014
    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

    (B)(4). CONCLUSION: IMPLANTING IN ZONE ONE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. HYBRID OPERATION FOR TYPE B AORTIC DISSECTION INVOLVING DISTAL AORTIC ARCH. ZHANG KEFENG, PAN XUDONG, LIU YONGMIN, ZHU JUNMING, HUANG LIANJUN, ZHANG JIAN AND SUN LIZHONG ON UNKNOWN DATES BETWEEN FEBRUARY 2009 TO APRIL 2013, A VALIANT MEDTRONIC STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A TYPE B DISSECTION. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: INFECTION, CVA, ENDOLEAK. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. ABSTRACT OBJECTIVES: TO RETROSPECTIVELY SUMMARIZE CLINICAL EXPERIENCES AND MID-TERM FOLLOW-UP OUTCOMES OF HYBRID OPERATION FOR TYPE B AORTIC DISSECTION INVOLVING THE DISTAL ARCH. METHODS: FROM FEBRUARY 2009 TO APRIL 2013, 15 CONSECUTIVE PATIENTS (6 MALES AND 9 FEMALES) WITH TYPE B AORTIC DISSECTION (ACUTE, N = 10; CHRONIC, N = 5) INVOLVING THE DISTAL AORTIC ARCH UNDERWENT A HYBRID OPERATION. RESULTS: THE PATIENTS¿ MEDIAN AGE WAS 62 (68¿44) YEARS. THE MEDIAN HOSPITAL STAY WAS 14 (19¿11) DAYS. THE HYBRID PROCEDURE WAS PERFORMED IN 15 PATIENTS COMPRISING SEVEN IN ZONE 1 AND EIGHT IN ZONE 2. TECHNICAL SUCCESS WAS ACHIEVED IN 100% AND NO CASE OF PARAPLEGIA WAS REPORTED. THIRTY-DAY MORTALITY AND STROKE WERE 0%. AT A MEDIAN FOLLOW-UP OF 12 MONTHS (RANGE, 4¿52 MONTHS), A STROKE AND DEATH OCCURRED IN ONE PATIENT NOT ASSOCIATED WITH AN ENDOGRAFT COMPLICATION. AT FOLLOW-UP, THE OVERALL MORTALITY WAS 6.7% (1 OF 15). A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED IN 13 OF 15 PATIENTS AND THROMBUS FORMATION WAS OBSERVED IN THE DESCENDING AORTIC FALSE LUMEN EXCLUDED BY THE STENTED GRAFT IN MOST PATIENTS. THE OVERALL LATE ENDOLEAK RATE WAS 7.7% (1 OF 13); RETROGRADE DISSECTION OCCURRED IN NO PATIENT. THERE ARE NO DIFFERENCES BETWEEN ACUTE AND CHRONIC AORTIC DISSECTION OR PROXIMAL LANDING ZONE 1 AND LANDING ZONE 2 EXCEPT FOR PROXIMAL ENDOGRAFT DIMENSION. CONCLUSIONS: HYBRID OPERATION FOR TYPE B AORTIC DISSECTION INVOLVING THE DISTAL AORTIC ARCH APPEARS SAFE AND EFFECTIVE AT MID-TERM FOLLOW-UP AND MAY EXTEND THE APPLICATION OF ENDOVASCULAR REPAIR IN THE TREATMENT OF THIS PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580386 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention