BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3215299 · Received July 10, 2013

    Report

    Report Number
    2953200-2013-01300
    Event Type
    Death
    Date Received
    July 10, 2013
    Date of Event
    August 1, 2008
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (SURGICAL CONVERSION, DEATH, ENDOLEAK, DISSECTION, ANEURYSM RUPTURE, OCCLUSION, STROKE, RENAL FAILURE, BLEEDING, FISTULA, INFECTION, PARALYSIS); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY DISSECTED THORACIC AORTA, PRE-OPERATIVE RUPTURE). CONCLUSION: INHERENT RISK OF A PROCEDURE (SURGICAL CONVERSION, DEATH, ENDOLEAK, DISSECTION, ANEURYSM RUPTURE, OCCLUSION, STROKE, RENAL FAILURE, BLEEDING, FISTULA, INFECTION, PARALYSIS); DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY DISSECTED THORACIC AORTA, PRE-OPERATIVE RUPTURE).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: EARLY CLINICAL EXPERIENCE WITH THE E-VITA THORACIC STENT-GRAFT SYSTEM; A SINGLE CENTER STUDY. J CARDIOVASC SURG 2008; 49: 417-28. ON AN UNKNOWN DATE UNKNOWN TALENT THORACIC STENT GRAFTS WERE IMPLANTED BETWEEN MAY 2004 AND MARCH 2008. AIM. THE AIM OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF A NEW ENDOVASCULAR THORACIC STENT-GRAFT, WHICH WAS DESIGNED TO OVERCOME THE RESTRICTIONS OF PREVIOUSLY USED STENT-GRAFTS. METHODS. BETWEEN MAY 2004 AND MARCH 2008 A PROSPECTIVE EVALUATION WAS CONDUCTED IN 126 CONSECUTIVE PATIENTS (71% MEN; AGE 64 [19-86] YEARS). A TOTAL OF 138 IMPLANTATIONS WERE PERFORMED. E-VITA STENT-GRAFTS WERE IMPLANTED FOR TYPE-B DISSECTION (N=56), DEGENERATIVE ANEURYSM (N-25), PENETRATING AORTIC ULCER (N=17), BLUNT TRAUMATIC LESIONS (N=10), MOBILE ATHEROMA (N=1), SUTURE ANEURYSMS (N=7) AND REVISIONARY SURGERY FOLLOWING PREVIOUS ENDOGRAFT IMPLANTATION (N=22). ALL PATIENTS ELIGIBLE FOR STENT-GRAFTING WERE TREATED WITH THIS SYSTEM REGARDLESS OF THEIR CLINICAL STATUS AND AORTIC PATHOLOGY. THE PERCENTAGE OF EMERGENCY PROCEDURES WAS 52% (N=72). PER IMPLANTATION A MEAN OF 1.3 SEGMENTS WAS IMPLANTED WITH AN EFFECTIVE TOTAL COVERED LENGTH OF THE AORTA OF MEAN 204 MM, MEDIAN 230 MM (0-4 50 MM). IN 32 OF 39 CASES WITH MORE THAN ONE SEGMENT, THE ENTIRE DESCENDING AORTA WAS INCLUDED IN THE PROCEDURE. RESULTS. THE 30-DAY MORTALITY RATE WAS 12.3% (17 PATIENTS). ALL DEATHS BUT ONE WERE IN THE GROUP OF EMERGENCY SURGERY PATIENTS. THIS RESULTS IN MORTALITY OF 1.5% IN THE ELECTIVE AND 22% IN THE EMERGENCY PROCEDURES. REVERSIBLE PROCEDURE-INDUCED SPINAL CORD ISCHEMIA WAS OBSERVED IN 2 CASES. STROKE OCCURRED IN 2.8% (4 PATIENTS). PRIMARY TECHNICAL SUCCESS WAS RATED AT 77 O/ (106 PROCEDURES) AND SECONDARY SUCCESS AT 89 % (124 PROCEDURES). CONCLUSION. ALL FORMS OF THORACIC AORTIC DISEASE CAN BE TREATED WITH THIS NEW STENT-GRAFT. IT HAS PROVED PARTICULARLY VALUABLE IN CASES OF DIFFICULT CONDITIONS IN THE AORTIC ARCH AND EXTENDED ANEURYSMS. IN PARTICULAR, IT IS POSSIBLE TO COVER THE ENTIRE THORACLC AORTA WITH TWO OR THREE STEM-GRAFT SEGMENTS, THUS CONSIDERABLY REDUCING THE NUMBER OF CONNECTIONS. THE FOLLOWING EVENTS WERE REPORTED: BLEEDING, RUPTURE PRE-OPERATIVE, SURGICAL CONVERSION, TYPE 1 ENDOLEAK, RUPTURE POST-OPERATIVE, DEATH WITHIN 30 DAYS (PROCEDURE RELATED), EOSOPHAGEAL FISTULA, DEPLOYMENT DIFFICULTY, INACCURATE DELIVERY, PERFORATION, BYPASS CONVERSION, VESSEL OCCLUSION BY STENT GRAFT, INFECTION, STROKE, PARAPLEGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316443 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention