BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 3103231 · Received May 9, 2013

    Report

    Report Number
    2953200-2013-00869
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (REMOVAL DIFFICULTIES); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; SEVERE CURVE/TORTUOSITY DISTALLY). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; SEVERE CURVE/TORTUOSITY DISTALLY).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A LARGE IN DIAMETER (EXACT SIZE IS UNKNOWN) THORACIC AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS SEVERE CURVE/TORTUOSITY IN THE THORACIC AORTA. THERE WAS MILD CALCIFICATION AND MILD THROMBOSIS. THE PATIENT PRESENTED EMERGENTLY COUGHING UP BLOOD. THE CT REVEALED A LARGE THORACIC ANEURYSM. THE PLAN WAS TO IMPLANT TWO DEVICES FROM DISTAL TO PROXIMAL. THE VALIANT CAPTIVIA 42X42X200 WAS ADVANCED TO THE INTENDED LANDING ZONE (4), THE STENT GRAFT WAS UNSHEATHED HOWEVER WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE TIP CAPTURE IT WOULD NOT RELEASE. THE PHYSICIAN FOLLOWED THE BAILOUT PROCEDURE PER THE IFU. BY FOLLOWING THE BAILOUT PROCEDURE THE TIP CAPTURE WAS ABLE TO BE RELEASED. THERE WERE NO ANATOMICAL ISSUES THAT WOULD HAVE CONTRIBUTED TO THE INABILITY FOR THE TIP CAPTURE TO BE RELEASED. THE STENT GRAFT WAS IMPLANTED AT THE INTENDED LOCATION HOWEVER; DUE TO THE SEVERE CURVE/TORTUOSITY AT THE DISTAL END OF THE STENT GRAFT IT WAS NOT LONG ENOUGH, SO THE PHYSICIAN IMPLANTED THE VALIANT CAPTIVIA 42X42X100 MOST DISTALLY. THERE WAS NOT A DISTAL TYPE I ENDOLEAK; THE PHYSICIAN KNEW THAT THE STENT GRAFT HAD NOT COVERED THE DISTAL AREA OF THE LANDING ZONE. IT WAS NOTED THAT THE FIGURE 8 MINIMAL OVERLAP MARKER WAS A '0' AND NOT A FIGURE '8' (BUT THE DEVICES WERE ALL CORRECTLY IMPLANTED). NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED IMAGE OF ALLEGED MARKER PROBLEM COULD NOT CONFIRM THAT THE MARKER WAS AN "O"; APPEARED TO BE AN ANGULATED "8". THE EVALUATION OF THE RETURNED DEVICE COMPLETED. THE COMPLAINT WAS CONFIRMED; A BAILOUT WAS USED TO DEPLOY THE STENT GRAFT. THE ROOT CAUSE OF THE DEPLOYMENT DIFFICULTY WAS CAUSED BY THE SILICONE SEAL BEING ADHERED TO THE CAPTURE LUMEN. THE CAUSE OF THE ADHERENCE OF THE SILICONE SEAL TO THE CAPTURE LUMEN IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202634 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04003223

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR