BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 14252788 · Received April 29, 2022

    Report

    Report Number
    2025587-2022-01231
    Event Type
    Death
    Date Received
    April 29, 2022
    Date of Event
    April 20, 2022
    Report Date
    June 9, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000211158
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: D-EVPROP34US, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN , UDI#: UNKNOWN. PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT ACCORDING THE PHYSICIAN, THE INITIAL LOSS IN PRESSURE WAS A RESULT OF RAPID PACING. PER THE PHYSICIAN, THE CAUSE OF THE DEATH WAS A RESULT OF A LEFT VENTRICLE FAILURE DUE TO THE RAPID PACING. THE PATIENT WAS IN SEVERE HEART FAILURE PRIOR TO THE TRANSCATHETER VALVE IMPLANT, AND THIS CONTRIBUTED TO THE IMPAIRMENT OF THE LEFT VENTRICLE. UPDATED B5. UPDATED B7. UPDATED H6. THE DELIVERY CATHETER SYSTEM (DCS) WAS DISCARDED AND THE VALVE REMAINS IMPLANTED. 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

    THE CONCOMITANT PRODUCT INFORMATION WAS RECEIVED: PRODUCT ID: D-EVPROP34US, LOT #: 0010989159, UBD: 2023-12-21, UDI#: (B)(4). 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 THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (F016888), WHEN THE VALVE WAS 80 PERCENT DEPLOYED, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP TO 48 SYSTOLIC AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE VALVE WAS RECAPTURED AND THE PATIENT WAS PLACED ON BYPASS. ONCE THE PATIENT WAS STABILIZED, A SECOND TRANSCATHETER VALVE (F020298) WAS LOADED AND WAS SUCCESSFULLY IMPLANTED. A POST BALLOON AORTIC VALVULOPLASTY (BAV) WAS COMPLETED WITH A 23 MILLIMETER (MM) NON-MEDTRONIC BALLOON WHILE RAPID PACING WAS PERFORMED AT 150 BEATS PER MINUTE (BPM). THE REASON FOR THE POST IMPLANT BAV WAS NOT REPORTED. THE PATIENT WAS NOTED TO BE STABLE AT THIS TIME WITH TRACE PARAVALVULAR LEAK (PVL). THE PATIENT WAS TAKEN OFF OF BYPASS. IMMEDIATELY THE PATIENT'S BLOOD PRESSURE DROPPED AGAIN TO 45 SYSTOLIC. CPR WAS PERFORMED A SECOND TIME AND MEDICATION WAS ADMINISTERED. THE PATIENT BEGAN TO RECOVER, HOWEVER WAS NOT SUSTAINED. CPR CONTINUED AND ADDITIONAL MEDICATION WAS ADMINISTERED. AN ANGIOGRAM WAS PERFORMED AND IT WAS DETERMINED THAT THERE WAS NO PVL OR CORONARY OBSTRUCTION. THE VALVE PLACEMENT WAS NOTED TO BE IDEAL. THE PATIENT'S LEFT VENTRICLE FUNCTION WAS UNABLE TO RECOVER AFTER THE RAPID PACING, AND THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103998 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-34US 00763000211158

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Required Intervention| D "SEE H10...."