BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 19263420 · Received May 7, 2024

    Report

    Report Number
    9612164-2024-02167
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    July 8, 2023
    Report Date
    May 7, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; PSEUDOANEURYSM AFTER ENDOVASCULAR REPAIR OF AORTIC TRANSECTION WODA L & BOYLE J EUR J VASC ENDOVASC SURG (2023) 66, 379 HTTPS://DOI.ORG/10.1016/J.EJVS.2023.07.008 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN A PATIENT ON AN UNKNOWN DATE IN 2010 FOR THE ENDOVASCULAR TREATMENT OF A TRAUMATIC AORTIC TRANSECTION FOLLOWING BLUNT INJURY TO THE CHEST WALL. SURVEILLANCE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING PERFORMED CONSECUTIVELY FOR THE FIRST FIVE YEARS SHOWED A STABLE APPEARANCE OF THE IMPLANTED STENT GRAFT. SUBSEQUENTLY, A CTA WHICH WAS PERFORMED ON AN UNKNOWN DATE DUE TO DILATED AORTIC ROOT SEEN ON ECHOCARDIOGRAPHY, REVEALED NEW MID THORACIC AORTIC ANEURYSMAL DILATATION TO 55 MM WITH TYPE 1B ENDOLEAK AT THE DISTAL END . IT IS HYPOTHESIZED THAT THE STENT GRAFT STRAIGHTENED OVER TIME CAUSING A DISTAL AORTICTEAR. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642136 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Unknown