BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 15543627 · Received October 5, 2022

    Report

    Report Number
    2953200-2022-00023
    Event Type
    Death
    Date Received
    October 5, 2022
    Date of Event
    January 26, 2009
    Report Date
    October 5, 2022
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; RETROGRADE TYPE A AORTIC DISSECTION AFTER ENDOVASCULAR STENT GRAFT PLACEMENT FOR TREATMENT OF TYPE B DISSECTION DONG ZH, FU WG, WANG YQ, GUO DQ, XU X, JI Y, CHEN B, JIANG JH, YANG J, SHI ZY, ZHU T, SHI Y. CIRCULATION. 2009;119 (5) PP. 735-741 DOI: 10.1161/CIRCULATIONAHA.107.759076. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT IN THE ENDOVASCULAR TREATMENT OF A TYPE B AORTIC DISSECTION ON AN UNKNOWN DATE OVER A 7 YEAR PERIOD. THE STENT GRAFT WAS PLACED IN THE DISTAL AORTIC ARCH WITH > 20-MM PROXIMAL LANDING ZONE AND 10 % STENT GRAFT OVERSIZING. AN EXTRA PROXIMAL FIXING AREA WAS CREATED BY INTENTIONAL COVERAGE OF THE LEFT SUBCLAVIAN ARTERY AND CERVICAL RECONSTRUCTION, RESPECTIVELY. THE INITIAL INDICATION FOR THE TREATMENT OF THE TYPE B AORTIC DISSECTION WAS RECURRENT PAIN. IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT GRAFT WAS INTENDED TO BE FIXED IMMEDIATELY DISTAL TO THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY WITH COVERAGE OF THE LEFT SUBCLAVIAN ARTERY. DURING THE DEPLOYMENT, THE STENT GRAFT MIGRATED SLIGHTLY DISTAL TO THE ANTICIPATED POSITION AFTER ITS FIRST SEGMENT WAS PARTIALLY RELEASED. THE WHOLE DELIVERY SYSTEM WAS PUSHED FORWARD GENTLY AND THEN FULLY DEPLOYED, ACHIEVING THE ANTICIPATED ALIGNMENT. THE COMPLETION ANGIOGRAM DEMONSTRATED THAT THE STENT GRAFT WAS PLACED IMMEDIATELY DISTAL TO THE LEFT COMMON CAROTID ARTERY WITH MILD ENDOLEAK AND LIMITED EXTRAVASATION OF CONTRAST AT THE ORIGIN OF THE INNOMINATE ARTERY WHERE THE TIP OF THE PROXIMAL BARE SPRING REACHED. GIVEN THE PATIENTS HEMODYNAMIC STABILITY AND DIFFICULTY IN ENDOVASCULAR MANAGEMENT AT THIS SITE, NO IMMEDIATE INTERVENTION WAS CARRIED OUT. IT WAS REPORTED THIS PATIENT HAD A SIGNIFICANTLY KINKED ARCH AND IN THIS CASE THE PROXIMAL PORTION OF THE STENT GRAFT FAILED TO ATTACH TO THE LESSER CURVE OF THE AORTIC ARCH. CONSEQUENTLY, THE STENT GRAFT WOULD BE LESS STABLE UNDER THE PULSATILE BLOOD FLOW AND THUS WOULD INCREASE THE RISK OF AORTIC WALL DAMAGE. TWO HOURS LATER, THE PATIENT PRESENTED WITH HYPOXEMIA, AND A RTAD WAS DETECTED BY TRANSTHORACIC ECHOCARDIOGRAPHY AT THE LOCATION OF THE TIP OF THE PROXIMAL BARE SPRING. IT WAS THOUGHT THE AORTIC WALL WAS INJURED BY PUSHING FORWARD THE PARTIALLY RELEASED STENT GRAFT DURING THE INDEX PROCEDURE. THE PATIENT DIED OF MULTIPLE ORGAN FAILURE 5 DAYS AFTER AN EMERGENCY ASCENDING THORACIC AORTA AND TOTAL ARCH REPLACEMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126619 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA UNK-CV-SR-TAL TAA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other| D| R