BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1650336 · Received March 31, 2010

    Report

    Report Number
    2953200-2010-00558
    Event Type
    Injury
    Date Received
    March 31, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 3, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). REQUIRED INTERVENTION. RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (CONICALLY SHAPED AORTIC NECK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PT CONDITION (CONICALLY SHAPED AORTIC NECK).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR 5.4 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS CONICAL IN SHAPE MEASURING 21 MM IN DIAMETER BELOW THE RENAL ARTERIES AND 27 MM DISTALLY, THERE WAS SEVERE STENOSIS BELOW THE RIGHT RENAL ARTERY. IT WAS REPORTED THERE WAS AN UNK ENDOLEAK THAT DID NOT RESOLVE WITH AGGRESSIVE BALLOONING. THE DECISION WAS MADE TO IMPLANT A LARGE PALMAZ STENT AND BALLOONED WITH A BRAUN 25MM BALLOON. THE ENDOLEAK IMPROVED, BUT DID NOT TOTALLY RESOLVE. THE PHYSICIAN BELIEVES THIS MAY BE A TYPE 1 OR TYPE 4 ENDOLEAK. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00288835

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention