BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3725437 · Received April 3, 2014

    Report

    Report Number
    2953200-2014-00626
    Event Type
    Death
    Date Received
    April 3, 2014
    Date of Event
    December 12, 2013
    Report Date
    March 10, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. PERIOPERATIVE AORTIC DISSECTION RUPTURE AFTER ENDOVASCULAR STENT GRAFT PLACEMENT FOR TREATMENT OF TYPE B DISSECTION. HUANG WEN-HUI, LUO SONG-YUAN, LUO JIAN-FANG, LIU YUAN, FAN RUI-XIN, XUE LING, YANG FANG, KANG HUI-YUAN, GU MENG-NAN, LIU ZHEN, XIE NIAN-JIN, DONG HAO-JIAN, NI ZHONG-HAN, HUANG MEI-PING AND CHEN JI-YAN. CHIN MED J 2013;126 (9): 1636-1641. ON UNKNOWN DATES BETWEEN 2004 TO DECEMBER 2011, A TALENT TAA STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A TYPE B DISSECTION. THE PATIENT EXPIRED NINE DAYS POST IMPLANT FROM A RETROGRADE TYPE A DISSECTION LEADING TO RUPTURE CAUSING DEATH. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. BACKGROUND THE PERIOPERATIVE AORTIC DISSECTION (AD) RUPTURE IS A SEVERE EVENT AFTER ENDOVASCULAR STENT GRAFT PLACEMENT FOR TREATMENT OF TYPE B AD. HOWEVER, THIS LIFE-THREATENING COMPLICATION HAS NOT UNDERGONE SYSTEMATIC INVESTIGATION. THE AIM OF THE STUDY IS TO DISCUSS THE REASONS OF AD RUPTURE AFTER THE PROCEDURE. METHODS THE MEDICAL RECORD DATA OF 563 STANFORD TYPE B AD PATIENTS WHO RECEIVED THORACIC ENDOVASCULAR REPAIR FROM 2004 TO DECEMBER 2011 AT OUR INSTITUTION WERE COLLECTED AND ANALYZED. DOUBLE ENTRY AND CONSISTENCY CHECKING WERE PERFORMED WITH EPIDATA SOFTWARE. RESULTS TWELVE PATIENTS DIED DURING THE PERIOPERATION AFTER THORACIC ENDOVASCULAR REPAIR, WITH AN INCIDENCE OF 2.1%, 66.6% WERE CAUSED BY AORTIC RUPTURE AND HALF OF THE AORTIC RUPTURE DEATHS WERE CAUSED BY RETROGRADE TYPE A AD. IN OUR STUDY, 74% OF THE NON-RUPTURE SURVIVING PATIENTS HAD THE FREE-FLOW BARE SPRING PROXIMAL STENT IMPLANTED, COMPARED WITH 100% OF THE AORTIC RUPTURE PATIENTS (74% VS. 100%, P=0.213). THE AORTIC RUPTURE PATIENTS ARE MORE LIKELY TO HAVE ASCENDING AORTIC DIAMETERS =4 CM (62.5% VS. 9.0%, P=0.032), INVOLVEMENT THE AORTIC ARCH CONCAVITY (62% VS. 27%, P=0.041) AND HAVE HAD MULTIPLE STENTS PLACED (P=0.039). CONCLUSIONS THORACIC AD ENDOVASCULAR REPAIR IS A SAFE AND EFFECTIVE TREATMENT OPTION FOR AD WITH RELATIVE LOW IN-HOSPITAL MORTALITY. AD RUPTURE MAY BE MORE COMMON IN ARCH STENT-GRAFT PATIENTS WITH AN ASCENDING AORTIC DIAMETER =4 CM AND WITH SEVERE DISSECTION THAT NEEDS MULTI-STENT PLACEMENT. ATTENTION SHOULD BE PAID TO A PROXIMAL BARE SPRING STENT THAT HAS A HIGHER PROBABILITY OF INDUCING AN AD RUPTURE. POST BALLOON DILATION SHOULD BE PERFORMED WITH SERIOUS CAUTION, PARTICULARLY FOR THE MIGRATION DURING DILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202485 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death