BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 18302936 · Received December 11, 2023

    Report

    Report Number
    2025587-2023-05146
    Event Type
    Death
    Date Received
    December 11, 2023
    Date of Event
    March 21, 2023
    Report Date
    January 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
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MOURA AR, RODRIGUES JA, BRAGA P, ET AL. IMPACT OF THE USE OF CUSP-OVERLAP PROJECTION ON THE INCIDENCE OF PERMANENT PACEMAKER IMPLANTATION POST-TRANSCATHETER AORTIC VALVE IMPLANTATION WITH SELF-EXPANDING VALVES. REV PORT CARDIOL. 2023;42(9):759-769. DOI:1 0.1016/J.REPC.2022.10.011 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021). EARLIEST APP ROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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. 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

    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE IMPACT OF THE CUSP-OVERLAP PROJECTION ON THE INCIDENCE OF PERMANENT PACEMAKER IMPLANTATION (PPMI) FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). A TOTAL OF 122 PATIENTS WHO UNDERWENT TAVI WITH A MEDTRONIC EVOLUT R OR EVOLUT PRO VALVE WERE INCLUDED IN THE STUDY POPULATION. THE AUTHORS OBSERVED TWO DEATHS DURING THE 30-DAY FOLLOW-UP PERIOD. THE FIRST DEATH OCCURRED DURING THE TAVI HOSPITALIZATION IN A PATIENT WHO NEEDED EMERGENT SURGERY FOR AORTIC EMBOLIZATION OF THE TRANSCATHETER VALVE, AND THE SECOND DEATH HAPPENED AFTER HOSPITAL DISCHARGE AND WAS DUE TO AN UNKNOWN CAUSE. OTHER OUTCOMES THAT OCCURRED WITHIN 30 DAYS OF TAVI INCLUDED: NEED FOR PPMI (INDICATIONS CONSISTED OF PERMANENT OR PAROXYSMAL COMPLETE ATRIOVENTRICULAR BLOCK (CAVB), 2:1 ATRIOVENTRICULAR BLOCK (AVB), OTHER); CONDUCTION RHYTHM COMPLICATIONS (NEW LEFT BUNDLE BRANCH BLOCK, HIGH-DEGREE AVB, CAVB); NEED FOR TEMPORARY PACEMAKER USE; VALVE ENTRAPMENT IN THE FEMORAL ARTERY REQUIRING SURGICAL VASCULAR INTERVENTION; NEED FOR SECOND VALVE IMPLANT; STROKE; AORTIC REGURGITATION (MODERATE TO SEVERE); MINOR OR MAJOR VASCULAR COMPLICATIONS (MAJORITY RELATED TO VASCULAR ACCESS HEMATOMA); AND MAJOR BLEEDING. NO FURTHER INFORMATION PERTAINING TO MEDTRONIC PRODUCTS WAS NOTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING PHYSICIAN/AUTHOR STATED THAT ONLY ONE OF THE TWO DEATHS WAS DIRECTLY RELATED TO THE USE OF A MEDTRONIC DEVICE (EVOLUT PRO VALVE). THIS WAS THE DEATH THAT OCCURRED AFTER THE VALVE EMBOLIZED AND WARRANTED EMERGENT SURGERY. THE PHYSICIAN/AUTHOR NOTED THAT THE VALVE EMBOLIZED RIGHT AFTER DEPLOYMENT AND RESULTED IN CARDIOGENIC SHOCK. THE PHYSICIAN/AUTHOR ALSO PROVIDED PERCENTAGES AND COUNTS FOR THE NON-DEATH ADVERSE OUTCOMES AS FOLLOWS: PERI-PROCEDURAL STROKE: 2.5% (N = 3, EVOLUT PRO WAS USED IN ALL 3 CASES); PERI-PROCEDURAL VASCULAR COMPLICATION: 23% (N = 28, EVOLUT PRO WAS USED IN 21 CASES AND EVOLUT R WAS USED IN 7 CASES); PERI-PROCEDURAL MAJOR BLEEDING: 4.9% (N = 6, EVOLUT PRO WAS USED IN 4 CASES AND EVOLUT R WAS USED IN 2 CASES); MODERATE TO SEVERE AORTIC REGURGITATION: 5.7% (N = 7, EVOLUT PRO WAS USED IN 4 CASES AND EVOLUT R WAS USED IN 3 CASES); PPMI: 27.9% (N = 34, EVOLUT PRO WAS USED IN 26 CASES AND EVOLUT R WAS USED IN 8 CASES). IN ADDITION, THE PHYSICIAN/AUTHOR STATED THAT ME DTRONIC DEVICE SERIAL OR LOT NUMBERS ARE UNABLE TO BE PROVIDED AND NO MEDTRONIC DEVICES ARE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304276 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention| D