BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 11626793 · Received April 7, 2021

    Report

    Report Number
    9612164-2021-01343
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    June 26, 2020
    Report Date
    April 7, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; SURGEON-MODIFIED ENDOVASCULAR GRAFTS FOR TREATING RUPTURED ARCH ANEURYSM DUE TO PROXIMAL ENDOGRAFT FAILURE AFTER THORACIC ENDOVASCULAR ANEURYSM REPAIR COMBINED WITH TOTAL DEBRANCHING TSUYOSHI SHIBATA, MASAMI SHINGAKI, KIYOFUMI MORISHITA, GENERAL THORACIC AND CARDIOVASCULAR SURGERY (2021) 69:118¿121 HTTPS://DOI.ORG/10.1007/S11748-020-01414-2. A PATIENT UNDERWENT TOTAL ARCH REROUTING FOLLOWED BY TEVAR FOR AN 80MM AORTIC ARCH ANEURYSM WHERE A VALIANT STENT GRAFT WAS CONSIDERED TO HAVE BEEN IMPLANTED. 3 DAYS POST THE PROCEDURE, A CTA WAS PERFORMED WHICH REVEALED SAC EXPANSION DUE TO A TYPE IA ENDOLEAK DURING REGULAR SURVEILLANCE. R E-INTERVENTIONS WERE RECOMMENDED, BUT THE PATIENT REFUSED FURTHER INTERVENTION. 1.5 YEARS LATER THE PATIENT PRESENTED WITH CHEST PAIN. THE PATIENT HEMODYNAMICALLY UNSTABLE. THERE WAS HIGH SUSPICION OF RUPTURED ARCH ANEURYSM AS A RESULT OF THE IA ENDOLEAK. THE PATIENT WAS TAKEN TO OR WHERE A FENESTRATED VALIANT CAPTIVIA STENT GRAFT WAS PREPARED TO BE IMPLANTED. STENT GRAFT MODIFICATION CONSISTED OF A PARTIALLY UNSHEATHED ENDOGRAFT, CREATION OF FENESTRATIONS, AND RELOADING OF THE ENTIRE GRAFT INTO THE EXISTING SHEATH. THE STENT GRAFT SYSTEM WAS ADVANCED INTO THE ASCENDING AORTA VIA THE RIGHT FEMORAL ARTERY, BLOOD PRESSURE MONITORING PROVIDED QUICK INFORMATION ON WHETHER THE STENT GRAFT OCCLUDED THE TARGET VESSEL OR NOT. A COMPLETION ANGIOGRAM DEMONSTRATED EXACT DEVICE POSITIONING WITHOUT ANY ENDOLEAKS. IT WAS REPORTED THE PATIENT EXPERIENCED DELIRIUM DURING RECOVERY AND WAS DISCHARGED FROM HOSPITAL 30 DAYS POST PROCEDURE. A CT ANGIOGRAM AT DISCHARGE SHOWED NO ENDOLEAKS WITHIN THE LENGTH OF THE 5-CM PROXIMAL LANDING ZONE, ACCORDING TO A CENTERLINE MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524545 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention