BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 17029156 · Received May 31, 2023

    Report

    Report Number
    9612164-2023-02309
    Event Type
    Death
    Date Received
    May 31, 2023
    Date of Event
    April 13, 2022
    Report Date
    May 31, 2023
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: INITIAL EXPERIENCE WITH FENESTRATED PHYSICIAN-MODIFIED STENT GRAFTS USING 3D AORTIC TEMPLATES RYNIO ET AL, J. CLIN. MED. 2022, 11(8), 2180; HTTPS://DOI.ORG/10.3390/JCM11082180 A2: MEAN AGE A3: MEAN GENDER D6A: EXACT DATE OF IMPLANT UNKNOWN MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT IN PATIENTS WITH JUXTARENAL AND SUPRARENAL AORTIC ANEURYSMS, TYPE IV THORACOABDOMINAL ANEURYSMS, AND TYPE IA ENDOLEAK AFTER ENDOVASCULAR AORTIC REPAIR. THE VALIANT GRAFTS WERE PHYSICIAN MODIFIED USING A 3D AORTIC TEMPLATE. ENDURANT IIS STENTS AND NON MDT STENTS WERE ALSO IMPLANTED. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: THERE WERE FIVE (12%) DEATHS DURING THE FIRST 30 DAYS POST-SURGERY COMPLICATIONS AFTER AN ILIAC ARTERY RUPTURE, ARRHYTHMIA, MULTISYSTEM ORGAN FAILURE, PULMONITIS AND PARAPLEGIA. THE CAUSE OF THE DEATHS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159673 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Death