BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2230649 · Received August 12, 2011

    Report

    Report Number
    2953200-2011-01433
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    December 2, 2010
    Report Date
    August 17, 2011
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK), (TYPE II ENDOLEAK), (IMPLANTING THE STENT GRAFT IN THE PROXIMAL THORACIC AORTA). CONCLUSION: (TYPE II ENDOLEAK), (IMPLANTING THE STENT GRAFT IN THE PROXIMAL THORACIC AORTA).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 6.2 CM IN DIAMETER X 10 CM LONG THORACIC AORTIC ANEURYSM IN ZONE 1 APPROX 9 MONTHS AGO. THE PROXIMAL AORTIC NECK DIAMETER WAS 42 MM, AND THE DISTAL AORTIC NECK WAS 34 MM IN DIAMETER. THERE WAS NO CALCIFICATION, BUT THERE WAS MILD THROMBUS AT THE DISTAL AORTIC NECK. IT WAS REPORTED THAT APPROX 3 WEEKS POST-IMPLANTATION, AN UNK ENDOLEAK, POSSIBLY A DISTAL TYPE I ENDOLEAK, A TYPE II ENDOLEAK, OR A JUNCTIONAL TYPE III ENDOLEAK BETWEEN THE DISTAL (B)(4) STENT GRAFT (MFR REPORT # 2953200-2011-01432) AND THE PROXIMAL (B)(4) STENT GRAFT (MFR REPORT # 2953200-2011-01433) WAS SEEN VIA CT. THE DIAMETER OF THE ANEURYSM HAD NOT BEEN INCREASING; THEREFORE, THE PHYSICIAN ELECTED TO MONITOR THE PT W/O ANY INTERVENTION. ON AN UNK DATE, A PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED, AND APPROX 1 MONTH AGO, THE PT RETURNED FOR AN INTERVENTION, AS THE PHYSICIAN PERFORMED COIL EMBOLIZATION, THE PROXIMAL TYPE I ENDOLEAK WORSENED. THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING A (B)(4) STENT GRAFT (MFR REPORT # 2953200-2011-01434) PROXIMALLY; HOWEVER, THE BARE SPRING INVERTED, AND THEN THE PHYSICIAN PULLED BACK ON DELIVERY SYSTEM TO CORRECT THE INVERTED BARE SPRING. ALTHOUGH THE BARE SPRING WAS CORRECTED, THE STENT GRAFT MOVED FROM ITS INTENDED PLACEMENT. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER (B)(4) STENT (MFR REPORT # 2953200-2011-01435); HOWEVER, THE BARE SPRING INVERTED, AND THE PHYSICIAN PUSHED AND PULLED ON THE DELIVERY SYSTEM TO TRY TO CORRECT THE BARE SPRING'S POSITION. THE PHYSICIAN WAS UNABLE TO CORRECT THE BARE SPRING, WHICH REMAINED MISALIGNED, AND THE PROXIMAL TYPE I ENDOLEAK REMAINED. NO FURTHER INTERVENTION WAS PERFORMED FOR THE PROXIMAL TYPE I ENDOLEAK. THERE WAS ALSO A DISTAL TYPE I ENDOLEAK; THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING A (B)(4) STENT GRAFT DISTALLY, WHICH SUCCESSFULLY RESOLVED THE DISTAL TYPE I ENDOLEAK. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. AN INTERNAL REVIEW OF POST-IMPLANT CTAS SHOWED A LIKELY TYPE III ENDOLEAK; ITS CAUSE COULD NOT BE DETERMINED. THE CINE FROM THE SECONDARY INTERVENTION CONFIRMED THE EVENTS AS DETAILED ABOVE. OF NOTE, THE CINE SHOWS THAT THE BARE SPRING OF THE PROXIMAL STENT GRAFT FROM THE INITIAL IMPLANT IS MISALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00548061

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention UNK.