BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2091666 · Received April 29, 2011

    Report

    Report Number
    2953200-2011-00909
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    November 16, 2010
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSIONS: (ENDOLEAK, AORTIC DISSECTION), (PRE-OPERATIVELY RUPTURE PENETRATING ULCER AND ANEURYSM), (TREATMENT OF A PRE-OPERATIVELY RUPTURE PENETRATING ULCER AND ANEURYSM).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A PRE-OPERATIVELY RUPTURED PENETRATING ULCER AND ANEURYSM IN THE DISTAL THORACIC ARCH APPROX FIVE MONTHS AGO. THE PT HAS A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, CHRONIC KIDNEY DISEASE, SEVERE EMPHYSEMA, PAD AND LEFT PLEURAL EFFUSION. IT WAS REPORTED THAT THE PENETRATING ULCER RUPTURED MOSTLY INTO THE PT'S MEDIASTINUM WITH A SIGNIFICANT AMOUNT OF HEMATOMA IN AND AROUND THE ESOPHAGUS AND BEHIND THE HEART. A CT SCAN WAS PERFORMED SIX DAYS POST IMPLANT SHOWED A TYPE I ENDOLEAK. THE PENETRATING ULCER THAT WAS INITIALLY TREATED APPEARED TO BE SEALED, HOWEVER, THERE WAS ANOTHER PENETRATING ULCER ON THE GREATER CURVE WHICH WAS FILLING WITH CONTRAST. A LEFT COMMON CAROTID TO SUBCLAVIAN BYPASS WAS PERFORMED AND IMPLANTED. ANOTHER 38 MM DIAMETER TALENT THORACIC STENT GRAFT WAS IMPLANTED JUST DISTAL TO THE BOVINE INNOMINATE ARTERY AND COVERED THE SUBCLAVIAN ARTERY. IT WAS NOTED THAT THE PT HAD LOW BLOOD PRESSURE AND CHEST COMPRESSIONS WERE STARTED AND MEDICATION WAS GIVEN AND THE PT WAS STABILIZED AT THAT TIME. A FINAL ANGIOGRAM WAS PERFORMED AND THERE WERE NO ENDOLEAK OR DISSECTIONS AT THIS TIME. IT WAS REPORTED TWO MONTHS POST INDEX PROCEDURE THE PT WAS READMITTED WITH A TYPE B FOCAL AORTIC DISSECTION DISTAL TO THE THORACIC STENT GRAFT AND THERE WAS NO ANEURYSMAL DEGENERATION (REF MFR # 2953200-2011-00910). ONE WEEK LATER THE PT WAS BROUGHT IN FOR REPAIR. THE DISSECTION HAD EXTENDED INTO THE UPPER ABDOMINAL AORTA INVOLVING THE CELIAC ARTERY. THE DISSECTION WAS TREATED WITH ANOTHER MFR'S GRAFT EXTENDING DOWN INTO THE ABDOMINAL AORTA AND THE CELIAC ARTERY WAS BYPASSED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00425882

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention