BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVEO PRO DELIVERY SYSTEM

    MDR report key: 19983242 · Received August 14, 2024

    Report

    Report Number
    2025587-2024-04586
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 5, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMF CODE 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.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    UPDATED B.5 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: EVOLUTPRO-26-US, SERIAL/LOT #: (B)(6), UBD: 14-FEB-2026, UDI#: (B)(4) PRODUCT ID: L-ENVPRO-16-US, SERIAL/LOT #: (B)(6), UBD: 2026-MAR-26, UDI#: (B)(4). OTHER CONCOMITANT DEVICE (S) ARE: PRODUCT ID: EVOLUTPRO-23-US, SERIAL/LOT #: (B)(6), UBD: 11-AUG-2024, UDI#: (B)(4). PRODUCT ID: L-ENVPRO-1623-US, SERIAL/LOT #: (B)(6), UBD: 2026-JAN-16, UDI#: (B)(4). PRODUCT ID: ENVPRO-16-US, SERIAL/LOT #: (B)(6), UBD: 2026-FEB-06, UDI#: (B)(4). 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT A 26 MILLIMETER (MM) VALVE (J217028) WAS ATTEMPTED FIRST AND DISLODGED. A SECOND 23 MM VALVE (F190756) WAS THEN ATTEMPTED. BOTH VALVES WERE EXPLANTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT AFTER THE 23MM VALVE WAS IMPLANTED, THE PATIENT EXPERIENCED HEMODYNAMIC INSTABILITY. BOTH VALVES WERE SUBSEQUENTLY EXPLANTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. PRIOR TO WITHDRAWING THE DELIVERY CATHETER SYSTEM (DCS), THE NOSE CONE WAS NOT CENTERED WITHIN THE FRAME INFLOW. PER THE PHYSICIAN, THE PATIENT'S AORTIC CALCIFICATION CONTRIBUTED TO THE DISLODGEMENT.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, NO MISLOAD WAS IDENTIFIED DURING LOADING. DURING THE VALVE IMPLANT, THE NOSE CONE OF THE DELIVERY CATHETER SYSTEM (DCS) DISLODGED THE VALVE. A PROCEDURAL DELAY RESULTED FROM THE VALVE DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263125 ENVEO PRO DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION ENVPRO-16-US 0012138225

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention "SEE H11...."