BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2040787 · Received March 31, 2011

    Report

    Report Number
    2953200-2011-00727
    Event Type
    Death
    Date Received
    March 31, 2011
    Date of Event
    October 9, 2010
    Report Date
    May 6, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: PARALYSIS, DEATH. RESULTS/CONCLUSIONS: CAROTID STENOSIS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FOR THIS CASE. THE INVESTIGATOR ASSESSED THAT IT WAS UNKNOWN WHETHER THE PATIENT'S DEATH WAS RELATED TO THE DEVICE AND THE CAUSE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 47 MM X 32 MM THORACIC AORTIC ANEURYSM ON (B)(6) 2010. THE PT HAS A HISTORY OF CAROTID STENOSIS. THE PROXIMAL AORTIC ARCH WAS 53 MM IN DIAMETER, DISTALLY IT WAS 29 MM. THERE WAS MODERATE CALCIFICATION OF THE ILIAC ARTERY, MILD CALCIFICATION AT THE PROXIMAL NECK AND DISTAL NECK, THERE WAS A MILD CLOT AT THE PROXIMAL NECK AND DISTAL NECK. IT WAS REPORTED THAT TWO STENT GRAFTS WERE IMPLANTED. ALSO, AT THE SAME TIME AN EVAR WAS PERFORMED FOR AN ABDOMINAL AORTIC ANEURYSM. THE FOLLOWING DAY POST IMPLANT PARAPLEGIA WAS CONFIRMED (SEE MFR # 2953200-2011-00728). REHABILITATION WAS DECIDED AND THE PT WAS IN REMISSION. THE INVESTIGATORS STATED THAT THE PARAPLEGIA RELATIONSHIP TO THE DEVICE IS UNK AND THERE IS NO RELATIONSHIP TO THE PROCEDURE. THE PHYSICIAN COMMENTED THAT BECAUSE AN EVAR WAS PERFORMED AT THE SAME TIME, IT IS POSSIBLE THAT THE ADAMKIEWICZ ARTERY WAS COVERED BY THE PROXIMAL PORTION OF ANOTHER MFR'S AAA STENT GRAFT AND CAUSED PARAPLEGIA. IT WAS REPORTED THAT THE PT EXPIRED FROM STOMACH CANCER ON (B)(6) 2010. THE INVESTIGATOR'S ASSESSMENT WAS THAT THE DEATH EVENT WAS NOT RELATED TO THE DEVICE OR THE PROCEDURE. THE PHYSICIAN'S COMMENTED THAT ADVANCED ANEMIA WAS CONFIRMED. SUSPECTED INTRAABDOMINAL BLEEDING AND EXECUTED ECHOCARDIOGRAPHY. DURING THE ECHOCARDIOGRAPHY, BLOOD PRESSURE DROPPED AND THE PT SUFFERED CARDIOPULMONARY ARREST. THE PT DID NOT RESPOND TO RESUSCITATION AND THE HEART BEAT DID NOT RESTART. BLEEDING FROM THE ABDOMINAL AORTA OR BLEEDING CAUSED BY TOTAL EXTIRPATION FOR THE STOMACH WAS SUSPECTED. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND NA V00548124

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death