BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA STENT GRAFT

    MDR report key: 4922268 · Received July 17, 2015

    Report

    Report Number
    2953200-2015-01054
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 19, 2015
    Report Date
    July 31, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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; RETROGRADE ASCENDING AORTIC DISSECTION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR FOR DISTAL AORTIC DISSECTION OR WITH ZONE 0 LANDING: ASSOCIATION, RISK FACTORS, AND TRUE INCIDENCE. DOI: 10.1016/J.ATHORACSUR.2015.02.095. OURANIA PREVENTZA, MD, ANDREA GARCIA, MD, KRISTY MOELLER, MD, DENTON A. COOLEY, MD, LORENA GONZALEZ, MD, BENJAMIN Y. CHEONG, MD, KALYAN VUNNAMADALLA, MD, AND JOSEPH S. COSELLI, MD ANN THORAC SURG (2015) A TALENT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABERRANT RETROESOPHAGEAL RIGHT SUBCLAVIAN ARTERY AND KOMMERELL DIVERTICULUM. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, RETROGRADE TYPE A AORTIC DISSECTION, PENETRATING ULCER, ENDOLEAK, FISTULA, TRANSECT ION, INACCURATE DELIVERY, CHEST PAIN, ASCENDING AORTA AND PROXIMAL ARCH REPLACEMENT. BACKGROUND: WE ATTEMPTED TO DETERMINE THE TRUE INCIDENCE OF RETROGRADE ASCENDING AORTIC DISSECTION (RAAD) AND TO CHALLENGE ITS REPORTED ASSOCIATION WITH DISTAL AORTIC DISSECTION OR ZONE 0 DEPLOYMENT. METHODS: FROM JANUARY 2005 TO AUGUST 2014, 305 PATIENTS WHO WERE AT RISK FOR RAAD UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR. WE EXCLUDED PATIENTS WITH PRIOR ASCENDING, HEMIARCH, OR TRADITIONAL OR FROZEN ELEPHANT TRUNK GRAFTS, OR WHO REQUIRED CONCOMITANT ASCENDING GRAFT PLACEMENT. PATIENTS IN GROUP A (N = 111, 36.4%) HAD DISTAL AORTIC DISSECTION OR HEMATOMA (N = 75, 67.6%) OR REQUIRED LANDING OF THE ENDOGRAFT IN ZONE 0 OF THE NATIVE ASCENDING AORTA (N=36, 32.4%). PATIENTS IN GROUP B (N = 194, 63.6%) HAD NON-DISSECTED DESCENDING OR DISTAL ARCH ANEURYSM (N = 172), PENETRATING ULCER (N= 9), COARCTATION (N=6), ENDOLEAK NOT CAUSED BY DISSECTION (N=3), AORTOBRONCHIAL FISTULA (N = 3), OR TRANSECTION (N = 1). RESULTS: THE INCIDENCE OF RAAD WAS 1.3% OVERALL (N = 4), 0.9% IN GROUP A (N = 1, COOK ZENITH TX2), AND 1.5% IN GROUP B (N=3; 1 TALENT CAPTIVIA, 2 COOK ZENITH TX2; P= 0.64). NO ZONE 0¿TREATED PATIENT HAD RAAD. TWO PATIENTS FROM GROUP B DIED, AND 1 WAS TREATED NON-OPERATIVELY. THE MEDIAN INTERVAL BETWEEN THORACIC ENDOVASCULAR AORTIC REPAIR AND RAAD WAS 11 DAYS (RANGE, 0 TO 90 DAYS). CONCLUSIONS: POST¿THORACICENDOVASCULAR AORTIC REPAIR RAAD IS A RARE BUT LETHAL COMPLICATION. OPERATOR EXPERIENCE IS CRUCIAL FOR PROMPT RECOGNITION AND PREVENTION. IT DOES NOT APPEAR THAT RAAD IS SPECIFICALLY ASSOCIATED WITH DISTAL AORTIC DISSECTION OR LANDING IN ZONE 0. TO OUR KNOWLEDGE, THIS IS ONE OF THE FEW STUDIES TO REPORT THE TRUE INCIDENCE OF RAAD IN AT-RISK PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465221 TALENT TAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention