BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2573727 · Received May 14, 2012

    Report

    Report Number
    2953200-2012-00952
    Event Type
    Death
    Date Received
    May 14, 2012
    Report Date
    April 19, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH), PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ACUTE TRAUMATIC RUPTURE). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ACUTE TRAUMATIC RUPTURE).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS. OPEN VERSUS ENDOVASCULAR REPAIR FOR PATIENTS WITH ACUTE TRAUMATIC RUPTURE OF THE THORACIC AORTA, J THORAC CARDIOVASC SURG 2011;142:1032-7. IN OUR SERIES, 40 PATIENTS (30 MALE; MEAN AGE, (B)(6)) UNDERWENT ENDOVASCULAR REPAIR FOR A TRAUMATIC RUPTURE OF THE THORACIC AORTA. TECHNICAL SUCCESS WAS OBTAINED IN ALL THE PATIENTS. THE TAG STENT-GRAFT (WL GORE (B)(4)) WAS USED IN 18 CASES, THE TALENT STENT-GRAFT (MEDTRONIC VASCULAR, (B)(4)) WAS USED IN 9 CASES, THE VALIANT STENT-GRAFT (MEDTRONIC VASCULAR) WAS USED IN 11 CASES, AND A ZENITH DISTAL EXTENSION CUFF (COOK INC) WAS USED IN 2 CASES. THE MEAN DIAMETER OF THE IMPLANTED STENT-GRAFT WAS 27-4 MM (RANGE, 18-40 MM), THE MEAN DISTAL AORTIC DIAMETER WAS 19.8-4.5 MM, AND THE MEAN STENT-GRAFT LENGTH WAS 106-22 MM (RANGE, 100-200 MM). THERE WAS ONLY ONE COMPLICATION, WITH THE MEDTRONIC DEVICE. IT WAS REPORTS THAT AT THE TIME OF IMPLANT DURING THE PROCEDURE WITH A VALIANT STENT GRAFT THERE WAS AN ILIAC RUPTURE THAT WAS INTRAOPERATIVE SURGICALLY REPAIRED. ONE PATIENT DIED OF A TRAUMATIC INTRACRANIAL HEMATOMA ON THE THIRD POSTOPERATIVE DAY. OBJECTIVE: THE STUDY OBJECTIVE WAS TO COMPARE THE OUTCOME BETWEEN OPEN AND ENDOVASCULAR REPAIR OF ACUTE TRAUMATIC RUPTURE OF THE THORACIC AORTA. METHODS: SEVENTY-FIVE PATIENTS (MEAN AGE (B)(6)) WITH AN ACUTE TRAUMATIC AORTIC RUPTURE WERE REFERRED TO (B)(6) BETWEEN (B)(6) 1990 AND (B)(6) 2010. BETWEEN (B)(6) 1990 AND (B)(6) 2000, 35 PATIENTS (33 MEN, (B)(6)) UNDERWENT SURGICAL REPAIR USING CARDIOPULMONARY BYPASS. FROM (B)(6) 2001, AN ENDOVASCULAR APPROACH WAS DELIBERATELY CHOSEN; 40 PATIENTS (30 MALE, (B)(6)) UNDERWENT ENDOVASCULAR REPAIR. THE 2 GROUPS WERE STATISTICALLY COMPARABLE. RESULTS: THE OVERALL MORTALITY RATES FOR THE SURGICAL AND ENDOVASCULAR GROUPS WERE (B)(4) (INTRAOPERATIVE MORTALITY: (B)(4)) AND (B)(4) ( INTRAOPERATIVE MORTALITY: (B)(4)), RESPECTIVELY. THE MORTALITY RATES RELATED TO AORTIC REPAIR FOR THE SURGICAL AND ENDOVASCULAR GROUPS WERE (B)(4), RESPECTIVELY. IN THE SURGICAL GROUP, THE MORBIDITY RATE WAS 14.2%: 4 CASES OF RECURRENT NERVE PALSY AND 1 CASE OF FALSE ANASTOMOTIC ANEURYSM WERE DIAGNOSED AT 52 MONTHS. IN THE ENDOVASCULAR GROUP, THE MORBIDITY RATE WAS (B)(4): 3 CASES OF INTRAOPERATIVE INADVERTENT COVERAGE OF SUPRA-AORTIC TRUNKS (REQUIRING A SECONDARY PROCEDURE IN 2 CASES AFTER 1 AND 2 YEARS TO REVASCULARIZE THE SUPRA-AORTIC TRUNKS), 1 PROXIMAL TYPE I ENDOLEAK (REQUIRING DEPLOYMENT OF A SECOND STENT-GRAFT AT DAY 2), 2 STENTGRAFT COLLAPSES IN THE FIRST POSTOPERATIVE MONTH (TREATED BY OPEN REPAIR AND EXPLANTATION IN 1 CASE AND BY THE DEPLOYMENT OF A SECOND STENT-GRAFT IN 1 CASE), 1 VERTEBROBASILAR INSUFFICIENCY AFTER LEFT SUBCLAVIAN ARTERY COVERAGE, AND 1 INTRAOPERATIVE ILIAC RUPTURE (SURGICALLY REPAIRED). NO CASES OF PARAPLEGIA OR STROKE WERE OBSERVED. THE MEDIAN FOLLOW-UP WAS 7.7 (RANGE, 0.4-15) YEARS. CONCLUSIONS: COMPARED WITH OPEN REPAIR, ENDOVASCULAR REPAIR OF TRAUMATIC THORACIC AORTIC RUPTURE IS ASSOCIATED WITH A LOWER DEATH RATE BUT FAILED TO REACH STATISTICAL SIGNIFICANCE, MOST LIKELY BECAUSE OF UNDERPOWERING. THESE RESULTS PROMPT US TO CONSIDER ENDOVASCULAR REPAIR AS THE FIRST-LINE THERAPY FOR ACUTE TRAUMATIC RUPTURE OF THE THORACIC AORTA, EXCEPT IN SOME RARE BUT CHALLENGING ANATOMIC SITUATIONS. NEW STENT-GRAFT DESIGNS, SIZES, AND DEPLOYMENT SYSTEMS COULD IMPROVE THE RESULTS OF ENDOVASCULAR REPAIR IN THESE INDICATIONS.

    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 CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention