BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 3748732 · Received April 14, 2014

    Report

    Report Number
    2953200-2014-00742
    Event Type
    Injury
    Date Received
    April 14, 2014
    Date of Event
    June 18, 2013
    Report Date
    March 26, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ENDOVASCULAR REPAIR OF TRAUMATIC THORACIC AORTIC RUPTURE: A SINGLE CENTRE EXPERIENCE. TOMASZ JAKIMOWICZ, OLGIERD ROWINSKI, ZBIGNIEW GALAZKA, BOHDAN SOLONYNKO, JACEK SZMIDT. KARDIOL POL 2013; 71, 12: 1273¿1278. A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF TRAUMATIC THORACIC AORTIC REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENT WAS OBSERVED: INTRAOPERATIVE ENDOLEAK. BACKGROUND: THORACIC AORTIC RUPTURE IS USUALLY THE RESULT OF A SUDDEN DECELERATION CAUSED BY A TRAFFIC ACCIDENT, FALL OR SOME OTHER MISFORTUNE. BEFORE THE ENDOVASCULAR ERA, THERE WAS ONLY ONE TREATMENT OPTION: OPEN REPAIR, BURDENED BY HIGH MORBIDITY AND SIGNIFICANT MORTALITY. NOW, WE HAVE THE ABILITY TO TREAT IT WITH A STENT GRAFT. THE ADVANTAGES OF THIS METHOD INCLUDE AVOIDING A THORACOTOMY OR AORTA CROSS-CLAMPING AND THEIR ASSOCIATED COMPLICATIONS. AIM: TO PRESENT OUR EXPERIENCE AND RESULTS OF ENDOVASCULAR TREATMENT OF THORACIC AORTIC RUPTURES. METHODS: SINCE 1998, WE HAVE PERFORMED ENDOVASCULAR TREATMENT FOR AORTIC LESIONS IN 1,598 PATIENTS. FROM THIS GROUP, THE INDICATION FOR STENT GRAFT IMPLANTATION IN 31 PATIENTS WAS A TRAUMATIC AORTIC RUPTURE OR PSEUDOANEURYSM CAUSED BY AN INJURY. ALL PATIENTS HAD A HISTORY OF BLUNT CHEST TRAUMA. THE SEQUENCE OF INJURY TREATMENT DEPENDED ON THE SEVERITY OF EACH. IN ALL BUT TWO PATIENTS, THE FIRST WAS AN AORTIC STENT GRAFT IMPLANTATION. THE LENGTH OF THORACIC AORTA COVERED RANGED FROM 100¿200 MM (MEAN 123 MM). WE DID NOT USE ANY METHOD OF SPINAL CORD ISCHAEMIA PROTECTION. FINAL ANGIOGRAPHY SHOWED COMPLETE EXCLU¬SION OF THE AORTIC DISRUPTION IN ALL PATIENTS. RESULTS: ALL BUT ONE OPERATION WAS SUCCESSFUL. ONE PATIENT DIED INTRAOPERATIVELY DUE TO CONCOMITANT INJURIES. AFTER THE OPERATION, NONE OF THE PATIENTS HAD SIGNS OF SPINAL CORD ISCHAEMIA OR ANY OTHER COMPLICATIONS THROUGH A FOLLOW-UP PERIOD RANGING FROM 12 TO 96 MONTHS (MEAN 40 MONTHS). CONCLUSIONS: OUR EXPERIENCE WITH TRAUMATIC THORACIC AORTIC RUPTURES SUGGESTS THAT ENDOVASCULAR TREATMENT SHOULD BE THE METHOD OF CHOICE, ESPECIALLY IN UNSTABLE MULTI-TRAUMA PATIENTS. HOWEVER, LONG-TERM STUDIES ARE REQUIRED TO ASSESS THE DURA¬BILITY OF THIS TECHNIQUE AFTER MANY YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227254 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Required Intervention