BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1940757 · Received December 22, 2010

    Report

    Report Number
    2953200-2010-02626
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (ENDOLEAK). (TYPE 2 ENDOLEAK).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.7 CM ABDOMINAL AORTIC ANEURYSM. THE VESSELS WERE UNREMARKABLE. IT WAS REPORTED THAT AFTER THE CONTRALATERAL LIMB WAS IMPLANTED AN UNK TYPE OF ENDOLEAK WAS EVIDENT AT THE CONTRALATERAL GATE (SEE MFR REPORT # 2953200-2010-02624). ANOTHER CONTRALATERAL LIMB (SEE MFR REPORT # 2953200-2010-02625) WAS USED TO RELINE THE FIRST LIMB; HOWEVER, THE ENDOLEAK WAS STILL PRESENT. NO FURTHER INTERVENTION WAS DONE, AND THE DECISION WAS MADE TO MONITOR THE PT. THE PT HAD NOT BEEN EXCESSIVELY HEPARINIZED DURING THE PROCEDURE AND BALLOONING WAS NOT AGGRESSIVE. FILMS WERE EVALUATED BY AN INDEPENDENT PHYSICIAN AND HIS IMPRESSION IS AS FOLLOWS: THE INTRA-OPERATIVE ANGIO FINDINGS WERE SUGGESTIVE FOR A TYPE 3 ENDOLEAK FROM THE CONTRA GATE, BETWEEN THE TALENT BIFURCATED GRAFT AND THE FIRST CONTRALATERAL LIMB. THE ENDOLEAK DID NOT RESOLVE AFTER PLACEMENT OF THE ADD'L EXTENSION WITHIN THAT AREA. THE POST-OP CT SHOWS AN ENDOLEAK, BUT ONE THAT IS NOT VERY IMPRESSIVE, AND CLEARLY CONNECTED TO AT LEAST 1 PAIR OF PATENT AND BACK-FLOWING LUMBAR ARTERIES. THE PHYSICIAN COMMENTED, THIS WAS A TYPE 2 ENDOLEAK OR, AT A MINIMUM, A COMBINATION OF A TYPE 2 AND SOMETHING ELSE AND THAT THE PT SHOULD BE MONITORED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00446507

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention