BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 1419380 · Received July 20, 2009

    Report

    Report Number
    2953200-2009-00961
    Event Type
    Death
    Date Received
    July 20, 2009
    Report Date
    June 22, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027/P07
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION - EVAL RESULTS AND CONCLUSION: (IDENTITY OF DEVICE AND OTHER DETAILS WERE NOT PROVIDED). ENDOVASCULAR REPAIR OF AORTIC ANEURYSM, PRELIMINARY RESULTS: SRP ARH CELOK LEK. 2009 JAN-FEB; 137 (1-2):10-7. DAVIDOVIC L, COLIC M, KONCAR I, MARKOVIC D, KOSTIC D, CINARA I, CVETKOVIS S.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: ENDOVASCULAR REPAIR OF AORTIC ANEURYSM, PRELIMINARY RESULTS: SRP ARH CELOK LEK. JAN-FEB 2009;137 (1-2):10-7. INTRODUCTION: ENDOVASCULAR ANEURYSM REPAIR (EVAR) HAS BEEN INTRODUCED INTO CLINICAL PRACTICE AT THE BEGINNING OF THE 90'S OF THE LAST CENTURY. BECAUSE OF ECONOMIC, POLITICAL AND SOCIAL PROBLEMS DURING THE LAST 25 YEARS, THE INTRODUCTION OF THIS PROCEDURE IN SERBIA WAS NOT POSSIBLE. OBJECTIVE: THE AIM OF THIS STUDY WAS TO PRESENT PRELIMINARY EXPERIENCES AND RESULTS OF THE CLINIC FOR VASCULAR SURGERY OF THE CLINICAL CENTRE IN ENDOVASCULAR TREATMENT OF THORACIC AND ABDOMINAL AORTIC ANEURYSMS. METHODS: THE PROCEDURE WAS PERFORMED IN A TOTAL PATIENTS (FEMALE AND MALE). TEN PATIENTS HAS A DESCENDING THORACIC AORTA ANEURYSM (THREE ATHEROSCLEROTIC, FOUR TRAUMATIC-THREE CHRONIC AND ONE ACUTE AS A PAIR OF POLYTRAUMA, ONE DISSECTED, TWO PENETRATED ATHEROSCLEROTIC ULCERS), WHILE A TOTAL PATIENTS AND THE ABDOMINAL AORTIC ANEURYSM, ONE RUPTURED AND TWO ISOLATED ILIAC ARTERY ANEURYSMS. THE INDICATIONS FOR EVAR WERE ISTHMIC ANEURYSMAL LOCALISATION, AND ASSOCIATED COMORBIDITY (CARDIAC, PULMONARY AND CEREBROVASCULAR DISEASES, PREVIOUS THORACOTOMY OR MULTIPLE LAPAROTOMIES ASSOCIATED WITH ABDOMINAL INFECTION, IDIOPATHIC THROMBOCYTOPAENIA). ALL OF THESE PATIENTS HAD THREE OR MORE RISK FACTORS. THE DIAGNOSIS WAS ESTABLISHED USING DUPLEX ULTRASONOGRAPHY, ANGIOGRAPHY AND MSCT. IN THE CASE OF THORACIC ANEURYSM, A MEDTRONIC-VALIANT ENDOVASCULAR ENDOVASCULAR STENT GRAFT WAS IMPLANTED, WHILE FOR THE ABDOMINAL AORTIC ANEURYSM MEDTRONIC-TALENT ENDOVASCULAR STENT GRAFTS WITH DELIVERY SYSTEMS WERE USED. IN THREE PATIENTS, FOLLOWING EVAR A SURGICAL REPAIR OF THE FEMORAL ARTERY ANEURYSM WAS PERFORMED, AND IN ANOTHER 3 PATIENT'S FEMORAL-FEMORAL CROSS OVER BYPASS FOLLOWED IMPLANTATION OF AORTOUNIILIAC STENT GRAFT. RESULTS: DURING PROCEDURE AND FOLLOW-UP PERIOD (MEAN 1.6 YEARS), THERE WERE: ONE DEATH, ONE CONVERSION, ONE ENDOLEAK TYPE 1, SOME PATIENT'S WITH ENDOLEAK TYPE 2 THAT DISAPPEARED DURING THE FOLLOW-UP PERIOD, ONE EARLY GRAFT THROMBOSIS. NO OTHER COMPLICATIONS, INCLUDING ANEURYSM EXPANSION, COLLAPSE, DEFORMITY AND MIGRATION OF THE ENDOVASCULAR STENT GRAFTS, WERE REGISTERED. THE PHYSICIAN WAS CONTACTED AND REQUESTED TO PROVIDE SPECIFIC INFORMATION RELATED TO EACH EVENT, SUCH AS LOT NUMBER, IMPLANT DATE, INTERVENTION AND PATIENT OUTCOME. AT THIS TIME NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| R