BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 19321125 · Received May 15, 2024

    Report

    Report Number
    9612164-2024-02331
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    September 29, 2023
    Report Date
    May 15, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; COMPARATIVE EFFECTIVENESS AND SAFETY OF LASER, NEEDLE, AND ¿QUICK FENESTRATER¿ IN IN SITU FENESTRATION DURING THORACIC ENDOVASCULAR AORTIC REPAIR WANG X, WU J, ZHI K, ZOU S, JIN J, BAI J AND QU L FRONT. CARDIOVASC. MED. 10:1250177. HTTPS://DOI.ORG/10.3389/FCVM.2023.1250177    EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. AVERAGE  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

    101 PATIENTS UNDERWENT A  TEVAR FOR AORTIC DISEASE (DISSECTION, N = 62; ANEURYSM, N = 16, OR ULCER, N = 23) ON UNKNOWN DATES OVER A 3 YEAR PERIOD . VALIANT CAPTIVIA AND NON MDT STENT GRAFTS WERE FENESTRATED USING EITHER A LASER , NEEDLE OR ¿QUICK FENESTRATER¿ PRIOR TO BEING IMPLANTED. THE TECHNICAL SUCCESS RATES OF THE LASER, NEEDLE, AND QF FENESTRATION GROUPS WERE 94.1%, 94.4%, AND 100%, RESPECTIVELY. THE FOLLOWING ADVERSE EVENTS WERE REPORTED;  ISCHEMIA, ACCESS SITE HEMATOMA, THROMBUS , OCCLUSION , INTERVENTION  PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MEDTRONIC STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358816 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Required Intervention| O