BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 13540310 · Received February 16, 2022

    Report

    Report Number
    9612164-2022-00629
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    November 13, 2021
    Report Date
    March 15, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    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; SAFETY AND DURABILITY OF SINGLE-STAGE TYPE I HYBRID TOTAL AORTIC ARCH REPAIR FOR EXTENSIVE AORTIC ARCH DISEASE: EARLY- AND LONG-TERM CLINICAL OUTCOMES FROM A SINGLE CENTER AND OUR 10-YEAR OF EXPERIENCE ZHANG B, WEI Y, LIU Y, LIN H, LIANG S, DUN Y, YU C, QIAN X, GUO H, SUN X JOURNAL OF THORACIC DISEASE. 2021;13(11):6230-6239, DOI: 10.21037/JTD-20-3479. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: IT WAS CONFIRMED THAT THE ADVERSE EVENTS REPORTED IN THIS JOURNAL ARTICLE ARE NOT DIRECTLY RELATED TO MEDTRONIC DEVICES. 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 , ENDURANT AND NON MDT STENT GRAFTS WERE IMPLANTED IN SINGLE-STAGE TYPE I HYBRID TOTAL ARCH REPAIR PROCEDURES ON UNKNOWN DATES OVER A 10 YEAR PERIOD. TYPE I HYBRID TOTAL AORTIC ARCH REPAIR WAS DEFINED AS SURGICAL TOTAL SUPRA-ARCH DEBRANCHING AND ZONE 0 STENT GRAFT DEPLOYMENT TO EXCLUDE THE ENTIRE DISEASED AORTIC ARCH. THE FOLLOWING MALFUNCTIONS WERE IDENTIFIED; TYPE IA ENDOLEAKS, FALSE LUMEN PERFUSION THE FOLLOWING ADVERSE EVENTS WERE IDENTIFIED; STROKE, RENAL THERAPY, RESPIRATORY FAILURE, DISSECTION, RUPTURE, RE-INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529752 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male