BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT CAPTIVIA STENT GRAFT

    MDR report key: 2101700 · Received May 11, 2011

    Report

    Report Number
    2953200-2011-00984
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    February 17, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEPLOYMENT DIFFICULTIES, CAUSE OF EVENT IS UNKNOWN. CONCLUSION: CAUSE OF EVENT IS UNKNOWN. EVALUATION SUMMARY: THE TAPER TIP WAS RECAPTURED INTO THE GRAFT COVER. THE SHEATH WAS FREE OF ANY KINKS. THE SLIDER WAS IN THE HOME POSITION. THE TIP CAPTURE RELEASE HANDLE WAS IN THE HOME POSITION, BUT NOT IN THE LOCKED POSITION. DURING EVALUATION, THE TIP CAPTURE RELEASE HANDLE WORKED FINE. THE STENT GRAFT DEPLOYMENT AND RECAPTURE MECHANISM WORKED FINE W/O ANY ISSUES.

    Additional Manufacturer Narrative · 1

    NOTIFICATION TO AFFECTED CUSTOMERS WAS MADE PER (B)(4) FOR THE APPROPRIATE BAILOUT TECHNIQUE AND MANUFACTURING PROCESS IMPROVEMENTS WERE IMPLEMENTED.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT CAPTIVA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC PENETRATING ULCER. THE VESSEL MORPHOLOGY WAS REPORTED AS MILD CALCIFICATION AND MILD TO MODERATE STEEP THORACIC ARCH. THE STENT GRAFT WAS ADVANCED TO THE INTENDED LANDING ZONE. THE PHYSICIAN PULLED THE BARE SPRING RELEASE BUTTON; HOWEVER, THE BARE SPRING RELEASE WOULD NOT RELEASE. THE RELEASE BUTTON WAS SLID BACK AND WOULD SPRING BACK TO THE ORIGINAL STARTING POSITION; THERE WAS TENSION IN THE RELEASE BUTTON. THE PHYSICIAN PUSHED, PULLED AND TORQUED THE DELIVERY SYSTEM AND THE APEXES WERE RELEASED FROM THE SPINDLE. THE STENT GRAFT WAS DEPLOYED AT THE INTENDED LOCATION. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT MIH MEDTRONIC IRELAND NA V00836145

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR