BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 16981282 · Received May 22, 2023

    Report

    Report Number
    2025587-2023-02150
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    April 28, 2023
    Report Date
    June 21, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE: EVOLUT PRO PLUS DELIVERY CATHETER SYSTEM (DCS) PRODUCT ID: D-EVPROP34, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN. CITATION: HIGUCHI R, TAKAMISAWA I, SEKI Y, IWAKURA T, NANASATO M. AORTIC LACERATION DURING RESHEATHING OF SELF-EXPANDING VALVE [PUBLISHED ONLINE AHEAD OF PRINT, 2023 APR 28]. CIRC J. 2023;10.1253/CIRCJ.CJ-23-0167. DOI:10.1253/CIRCJ.CJ-23-0167 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. ANNEX G CODE G04027 PERTAINS TO THE VALVE. ANNEX G CODE G07001 PERTAINS TO THE DCS. 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: SECTION D4 (PRIMARY PRODUCT) - MODEL #, CATALOG #, EXPIRATION DATE, SERIAL #, UNIQUE IDENTIFIER (UDI) # SECTION D10 (CONCOMITANT PRODUCT) - MODEL #: D-EVPROP34US, CATALOG #: D-EVPROP34US, EXPIRATION DATE: 2024-03-01, LOT #: 0011099256, UNIQUE IDENTIFIER (UDI) #: (B)(4), SECTION H4 (PRIMARY PRODUCT) - DEVICE MFG DATE SECTION H4 (CONCOMITANT PRODUCT) - DEVICE MFG DATE: 2022-03-02 A SEARCH OF THE MEDTRONIC GLOBAL COMPLAINT HANDLING DATABASE WITH THE PROVIDED UNIQUE DEVICE IDENTIFIER SERIAL/LOT NUMBERS FOUND A PREVIOUS RECORD FOR THESE OBSERVATIONS. PLEASE REFERENCE REGULATORY REPORT NUMBERS 2025587-2023-00854, 2025587-2023-00854 (FOLLOW UP NUMBER: 001), AND 2025587-2023-00854 (FOLLOW UP NUMBER: 002) FOR INFORMATION PERTAINING TO THIS EVENT. 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

    LITERATURE WAS REVIEWED REGARDING A PATIENT WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A MEDTRONIC 34 MM EVOLUT PRO+ SYSTEM. DURING THE PROCEDURE, A PRE-IMPLANT DILATION WAS PERFORMED WITH A 24 MM BALLOON. AFTERWARD, THE AUTHORS TRIED TO DEPLOY THE EVOLUT PRO+ VALVE IN A SHALLOW POSITION, BUT THE VALVE ¿POPPED UP.¿ THE VALVE WAS RESHEATHED AND A SECOND DEPLOYMENT WAS ATTEMPTED, BUT THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND ARREST. THEN THE AUTHORS WROTE, ¿WE PROMPTLY PERFORMED PERICARDIOCENTESIS, AND SURGICALLY REPLACED THE AORTIC VALVE AND ASCENDING AORTA. VISUAL INSPECTION REVEALED A TRANSVERSE LACERATION OF THE AORTIC INTIMA-MEDIA, 25 MM ABOVE THE ANNULUS, PART OF WHICH HAD PERFORATED EXTERNALLY.¿ IT WAS STATED THAT THE LOWER EDGE OF THE VALVE FRAME MAY HAVE CUT THE AORTA DURING RESHEATHING, AND AORTIC VULNERABILITY IN A PATIENT WITH A BICUSPID VALVE MAY HAVE ALSO CONTRIBUTED TO THE AORTIC LACERATION/DISSECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849097 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-34US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L "SEE H10...."