BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVEO R DELIVERY SYSTEM

    MDR report key: 13233142 · Received January 11, 2022

    Report

    Report Number
    2025587-2022-00082
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    December 2, 2021
    Report Date
    January 18, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: JANG ET AL. PITFALLS IN RECAPTURE OR REPOSITIONING OF EVOLUT SYSTEM USING CUSP OVERLAP TECHNIQUE. EUR HEART J. 2021 DEC 2;EHAB824. DOI: 10.1093/EURHEARTJ/EHAB824. EARLIEST DATE OF PUBLISH 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. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MEDTRONIC GLOBAL COMPLAINT HANDLING DATABASE WITH THE PROVIDED UNIQUE DEVICE IDENTIFIER NUMBERS FOUND NO PREVIOUS RECORDS. 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

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING AN (B)(6) -YEAR-OLD MALE WITH SYMPTOMATIC SEVERE AORTIC STENOSIS WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANT OF A MEDTRONIC 29-MM EVOLUT R BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). A COMPUTED TOMOGRAPHY REVEALED A HORIZONTAL AORTA ALONG WITH HEAVY CALCIFICATION OF BOTH RIGHT AND NON-CORONARY CUSPS. THE VALVE IMPLANT WAS ATTEMPTED UTILIZING THE CUSP OVERLAP TECHNIQUE, BUT IT TENDED TO MIGRATE UPWARD DURING POSITIONING. AFTER THREE UNSUCCESSFUL ATTEMPTS TO DEPLOY THE VALVE IT WAS RECAPTURED IN THE DELIVERY CATHETER SYSTEM (DCS) AND REMOVED FROM THE PATIENT. VISUAL INSPECTION NOTED AORTIC VALVE DEBRIS BETWEEN THE INFLOW STRUTS AND NOSE CONE, AND INFOLDING OF THE RETRIEVED VALVE WHICH THE AUTHORS SUSPECTED TO BE ASSOCIATED WITH THE MULTIPLE RECAPTURES IN THE PRESENCE OF SIGNIFICANT ANNULAR CALCIFICATION. A SECOND VALVE WAS ATTEMPTED USING CONVENTIONAL IMPLANTATION TECHNIQUE, WHICH WAS SUCCESSFULLY IMPLANTED WITH MILD PARAVALVULAR LEAK. THE PATIENT WAS DIS CHARGED UNEVENTFULLY FOUR DAYS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Description of Event or Problem · 0

    JANUARY 17, 2022 - ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR PROVIDED UNIQUE DEVICE IDENTIFIERS FOR THE TWO EVOLUT R VALVES (EVOLUTR-29/ D579624 UNSUCCESSFUL IMPLANT, EVOLUTR-29/ D580457 SUCCESSFUL IMPLANT) AND THE PATIENT'S WEIGHT OF 66 KG. NO DEVICES WERE AVAILABLE TO BE RETURNED FOR PHYSICAL ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888116 ENVEO R DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION ENVEOR-L UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Required Intervention