BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT

    MDR report key: 2153231 · Received June 23, 2011

    Report

    Report Number
    2953200-2011-01188
    Event Type
    Injury
    Date Received
    June 23, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: ENDOLEAK, PRE-OPERATIVE DISSECTION, TREATMENT OF A PRE-OPERATIVE DISSECTION. CONCLUSION: TREATMENT OF A PRE-OPERATIVE DISSECTION. THE PHYSICIAN WAS CONTACTED AND REQUESTED TO PROVIDE SPECIFIC INFORMATION RELATED TO THIS EVENT, SUCH AS THE LOT NUMBER AND IMPLANT DATE. NO REPLY HAS BEEN RECEIVED FROM THE PHYSICIAN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: COMPLICATIONS AFTER ENDOVASCULAR REPAIR OF TYPE B AORTIC DISSECTION; J. ENDOVASC. THER. 2002;9:822-828. PURPOSE: TO OUTLINE THE COMPLICATIONS ENCOUNTERED AFTER ENDOLUMINAL TREATMENT IN PATIENTS WITH TYPE B AORTIC DISSECTION. METHODS: BETWEEN 1999 AND 2001, 14 PATIENTS (12 MEN; MEAN AGE 60.3 YEARS, RANGE 39-79) WITH ISOLATED TYPE B AORTIC DISSECTIONS (13 CHRONIC, 1 ACUTE) UNDERWENT AORTIC STENT GRAFTING. FOURTEEN STENT GRAFTS FROM ANOTHER MANUFACTURER AND THREE TALENT STENT GRAFTS WERE IMPLANTED IN THE STUDY. ONE PATIENT HAD A CHRONIC TYPE B AORTIC DISSECTION LOCATED 25 MM DISTAL TO THE LEFT SUBCLAVIAN ARTERY WITH AN INFRARENAL RE-ENTRY SITE. A TALENT THORACIC STENT GRAFT WAS IMPLANTED, BUT DID NOT COVER THE LEFT SUBCLAVIAN ARTERY. THERE WAS A TYPE I ENDOLEAK DUE TO AN INCOMPLETELY SEALED ENTRY SITE OF THE DISSECTION. THE PHYSICIAN ELECTED TO INTERVENE WITH A STENT GRAFT FROM ANOTHER MANUFACTURER, WHICH WAS IMPLANTED TO COVER THE LEFT SUBCLAVIAN ARTERY AND EXTENDED TO THE ORIGIN OF THE LEFT COMMON CAROTID ARTERY. AFTER THE INTERVENTION, TOTAL THROMBOSIS OF THE FALSE LUMEN OF THE DISSECTION WAS OBSERVED; COMPLETE REDUCTION OF THE FALSE LUMEN WAS CONFIRMED AT THE 18-MONTH EVALUATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention