BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT TAA

    MDR report key: 3217961 · Received July 10, 2013

    Report

    Report Number
    2953200-2013-01347
    Event Type
    Death
    Date Received
    July 10, 2013
    Date of Event
    October 11, 2010
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (TYPE I ENDOLEAK, RENAL FAILURE, DEATH, AORTOESOPHAGEAL FISTULA, REMOVAL OF IMPLANT AND OPEN REPAIR). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY DISSECTED THORACIC AORTA). (UNKNOWN CAUSE OF THE EVENT). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY DISSECTED THORACIC AORTA). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED, MIDTERM RESULTS WITH THORACIC ENDOVASCULAR AORTIC REPAIR FOR CHRONIC TYPE B AORTIC DISSECTION WITH ASSOCIATED ANEURYSM. CYRUS J. PARSA, MD, JUDSON B. WILLIAMS, MD, SYAMAL D. BHATTACHARYA, MD, WALTER G. WOLFE, MD, MANI A. DANESHMAND, MD, RICHARD L. MCCANN, MD, AND G. CHAD HUGHES, MD (J THORAC CARDIOVASC SURG 2011;141:322-7) OBJECTIVE: THORACIC ENDOVASCULAR AORTIC REPAIR FOR CHRONIC TYPE B AORTIC DISSECTION WITH ASSOCIATED DESCENDING THORACIC ANEURYSM REMAINS CONTROVERSIAL. CONCERNSINCLUDE POTENTIAL ISCHEMIC COMPLICATIONS DUE TO BRANCH VESSEL ORIGIN FROM THE CHRONIC FALSE LUMEN AND CONTINUED RETROGRADE FALSE LUMEN/ANEURYSM SAC PRESSURIZATION VIA FENESTRATIONS DISTAL TO IMPLANTED ENDOGRAFTS. THE PRESENT STUDY EXAMINES MIDTERM RESULTS WITH THORACIC ENDOVASCULAR AORTIC REPAIR FOR CHRONIC (>2 WEEKS) TYPE B AORTIC DISSECTION WITH ASSOCIATED ANEURYSM TO BETTER UNDERSTAND THE POTENTIAL ROLE OF THORACIC ENDOVASCULAR AORTIC REPAIR FOR THIS CONDITION. METHODS: BETWEEN MARCH 2005 AND DECEMBER 2009, 51 THORACIC ENDOVASCULAR AORTIC REPAIR PROCEDURES WERE PERFORMED AT A SINGLE INSTITUTION FOR MANAGEMENT OF CHRONIC TYPE B DISSECTION. THE INDICATION FOR THORACIC ENDOVASCULAR AORTIC REPAIR WAS ANEURYSM IN ALL CASES. A SUBSET OF 7 PATIENTS (14%) UNDERWENT PLACEMENT OF THE ENDOSURE WIRELESS PRESSURE MEASUREMENT SYSTEM (B)(4) IN THE FALSE LUMEN ADJACENT TO THE PRIMARY TEAR FOR MONITORING ANEURYSM SAC/FALSE LUMEN PULSE PRESSURE AFTER THORACIC ENDOVASCULAR AORTIC REPAIR. RESULTS: MEAN PATIENT AGE WAS 57 _ 12 YEARS (RANGE, 30¿82 YEARS); 14 PATIENTS (28%) WERE FEMALE. MEAN AORTIC DIAMETER WAS 6.2 _ 1.4 CM. THERE WERE NO IN-HOSPITAL/30-DAY DEATHS, STROKES, OR PERMANENT PARAPLEGIA/PARESIS. THERE WERE NO COMPLICATIONS RELATED TO COMPROMISE OF DOWNSTREAM BRANCH VESSELS ARISING FROM THE FALSE LUMEN. TWO PATIENTS (3.9%) WHO HAD PREEXISTING ASCENDING AORTIC DILATION HAD RETROGRADE ACUTE TYPE A AORTIC DISSECTION; BOTH WERE REPAIRED SUCCESSFULLY. MEDIAN POSTOPERATIVE LENGTH OF STAY WAS 4 DAYS. MEAN FOLLOW-UP IS 27.0 _ 16.5 MONTHS (RANGE, 2¿60 MONTHS).ACTUARIAL OVERALL SURVIVAL IS 77.7%AT 60 MONTHS WITH AN ACTUARIAL AORTA-SPECIFIC SURVIVAL OF 98%OVER THIS SAME TIME PERIOD. ACTUARIAL FREEDOM FROM REINTERVENTION IS 77.3%AT 60 MONTHS. ALL PATIENTS WITH THE ENDOSURE WIRELESS PRESSURE MEASUREMENT SYSTEM EXHIBITED A DECREASE IN ANEURYSM SAC/FALSE LUMEN PULSE PRESSURE INDICATING A DEPRESSURIZED FALSE LUMEN. THE ANEURYSM SAC/FALSE LUMEN PULSE PRESSURE RATIO DECREASED FROM 52% _ 27% AT THE PREDISCHARGE MEASUREMENT TO 14% _ 5% AT THE LATEST FOLLOW-UP READING (P ¼ .029). CONCLUSIONS: THORACIC ENDOVASCULAR AORTIC REPAIR FOR CHRONIC TYPE B DISSECTION WITH ASSOCIATED ANEURYSM IS SAFE AND EFFECTIVE AT MIDTERM FOLLOW-UP. ANEURYSM SAC/FALSE LUMEN PULSE PRESSURE MEASUREMENTS DEMONSTRATE A SIGNIFICANT REDUCTION IN FALSE LUMEN ENDOTENSION, THUS RULING OUT CLINICALLY SIGNIFICANT PERSISTENT RETROGRADE FALSE LUMEN PERFUSION AND PROVIDE PROOF OF CONCEPT FOR A THORACIC ENDOVASCULAR AORTIC REPAIR-BASED APPROACH. LONGER-TERM FOLLOW-UP IS NEEDED TO DETERMINE THE DURABILITY OF THORACIC ENDOVASCULAR AORTICREPAIR FOR THIS AORTIC PATHOLOGY. (J THORAC CARDIOVASC SURG 2011;141:322-7).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317573 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR