BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1924495 · Received December 7, 2010

    Report

    Report Number
    2953200-2010-02436
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 1, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK), (STENT GRAFT IMPLANTED WITHIN A PREVIOUSLY IMPLANTED SYNTHETIC GRAFT), (PREVIOUSLY IMPLANTED SYNTHETIC GRAFT). EVAL, CONCLUSION: (STENT GRAFT IMPLANTED WITHIN A PREVIOUSLY IMPLANTED SYNTHETIC GRAFT), (PREVIOUSLY IMPLANTED SYNTHETIC GRAFT).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A TYPE B DISSECTION OF AN ANASTOMOTIC ANEURYSM AT THE DISTAL END OF A PREVIOUSLY IMPLANTED SYNTHETIC GRAFT WHICH WAS IMPLANTED TO REPLACE THE AORTIC ARCH. THE PROXIMAL NECK DIAMETER WAS 25 MM, DISTAL NECK DIAMETER IS 18 MM. IT WAS REPORTED THAT AFTER THE STENT GRAFTS WERE IMPLANTED, TOUCH-UP WITH A RELIANT BALLOON WAS PERFORMED SEVERAL TIMES. THERE WAS AN ENDOLEAK CONFIRMED, A PALMAZ STENT WAS IMPLANTED TO COVER THE PROXIMAL MAIN DEVICE AND HOME-MADE STENT GRAFT WAS IMPLANTED TO COVER THE JUNCTION BETWEEN PROXIMAL MAIN AND THE DISTAL MAIN (SEE MFR # 2953200-2010-02437). THERE WAS A SLIGHT TYPE 1 ENDOLEAK REMAINING; HOWEVER, IT WAS UNDETERMINED WHETHER IT WAS A TYPE IA OR TYPE IB. THE PHYSICIAN DECIDED TO KEEP MONITORING THE LEAK WITHOUT ANY ADD'L TREATMENT. F/U WAS PERFORMED ON (B)(6) 2010, TO CONFIRM THE STATUS OF THE REMAINING TYPE 1 ENDOLEAK AND IT WAS CONFIRMED TO BE COMING FROM THE PROXIMAL SEAL ZONE. COIL EMBOLIZATION WAS PERFORMED; HOWEVER, A SLIGHT ENDOLEAK REMAINED AND THE OPERATION WAS CLOSED WITH THE DECISION TO KEEP MONITORING THE PT. ANOTHER F/U WAS PERFORMED AGAIN ON (B)(6) 2010 AND IT WAS CONFIRMED THERE WAS A SLIGHT ENDOLEAK REMAINING. ANOTHER COIL EMBOLIZATION WAS PERFORMED TO ADDRESS THE ENDOLEAK AND THIS SUCCESSFULLY RESOLVED THE ENDOLEAK. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. THE PHYSICIAN THINKS THE DEFECTIVE CRIMPING SEEMS TO BE THE POSSIBLE CAUSE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00528978

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention