BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT (CT)

    MDR report key: 1960866 · Received January 12, 2011

    Report

    Report Number
    2953200-2011-00083
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 12, 2010
    Report Date
    November 6, 2015
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSIONS: (PRE-OPERATIVE RUPTURED ANEURYSM), (ENDOLEAK), (STENT GRAFT WAS IMPLANTED FOR THE TREATMENT OF A PRE-OPERATIVELY RUPTURED ANEURYSM).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYS WAS IMPLANTED IN A PT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED PENETRATING AORTIC ULCER. VESSEL MORPHOLOGY INCLUDING ULCER SIZE AND AORTA DIAMETER ARE UNK. THE TALENT TF2626 WAS IMPLANTED DISTALLY AND THE TALENT TF3434 SYS WAS INSERTED INTO THE ASCENDING AORTA AND WAS INADVERTENTLY IMPLANTED HIGHER THAN INTENDED. THE PHYSICIAN PULLED THE GRAFT COVER TOO MUCH AND THE 3RD AND FOURTH STENT RINGS WERE DEPLOYED BEFORE THE PHYSICIAN INTENDED. THE DISTAL EDGE OF TF3434 WAS BARELY OVERLAPPING/CONNECTED INTO THE TF2626. THE PHYSICIAN ADJUSTED THE POSITION OF THE IMPLANTED TF3434 BY BALLOON, MOVING THE STENT GRAFT TOWARD THE TARGET POSITION. AFTER ADJUSTMENT OF TF3434, THERE WERE NO ENDOLEAKS PRESENT AND THE PROCEDURE WAS COMPLETED AND THE PT WAS CLOSED. JUST AFTER THE PROCEDURE/OPERATION, THE PT'S BLOOD PRESSURE DROPPED. THE DSA REVEALED THAT THERE WAS A JUNCTION TYPE III ENDOLEAK BETWEEN THE TWO DEVICES. THE PHYSICIAN IMPLANTED ANOTHER MFR'S 28MM STENT GRAFT BETWEEN THE TWO DEVICES AT THE JUNCTION AND THE ENDOLEAK WAS RESOLVED. (MFR 2953200-2011-00082 - 2953200-2011-00083). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT (CT) MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00540491

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Unknown Required Intervention