BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 14307482 · Received May 6, 2022

    Report

    Report Number
    2025587-2022-01274
    Event Type
    Death
    Date Received
    May 6, 2022
    Date of Event
    February 21, 2022
    Report Date
    May 24, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: DEL VAL D, ET AL. ANTERIOR MITRAL LEAFLET DISSECTION AND PSEUDOANEURYSM LATE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT: LOOK BEYOND THE OBVIOUS. CIRC CARDIOVASC IMAGING. 2022 MAR;15(3):E013724. DOI: 10.1161/CIRCIMAGING.121.013724. EPUB 2022 FEB 21. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH. 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

    UPDATED INFORMATION: A4. WEIGHT IN LBS B5. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THE EVOLUT PRO WAS A CONTRIBUTORY FACTOR IN THE PATIENT'S DEATH AND THE PROBABLE CAUSE OF THE WALL DISRUPTION/RUPTURE WAS THE COMBINATION OF SEVERE LVOT CALCIFICATION AND THE BALLOON POST-DILATION OF THE VALVE. D4. EXPIRATION DATE, SERIAL #, UNIQUE IDENTIFIER (UDI) # H4. DEVICE MFG DATE A SEARCH OF THE MEDTRONIC GLOBAL COMPLAINT HANDLING DATABASE WITH THE PROVIDED UNIQUE DEVICE IDENTIFIER SERIAL NUMBER DID NOT FIND A PRE-EXISTING COMPLAINT FILE FOR THESE 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE CASE REPORT REGARDING AN (B)(6) FEMALE PATIENT WITH SEVERE AORTIC STENOSIS WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 26 MM MEDTRONIC EVOLUT PRO VALVE (UNIQUE DEVICE IDENTIFIER NUMBER NOT PROVIDED). FOLLOWING VALVE DEPLOYMENT, AN ANGIOGRAM REVEALED A LOW IMPLANT DEPTH WITH MILD UNDER-EXPANSION OF THE EVOLUT PRO FRAME AND MODERATE TO SEVERE PARAVALVULAR LEAK. CONSEQUENTLY, A POST-DILATION WAS PERFORMED WITH A 20 MM Z-MED BALLOON. AFTERWARD, ECHOCARDIOGRAPHY SHOWED MILD RESIDUAL AORTIC REGURGITATION. THE PATIENT WAS DISCHARGED THREE DAYS LATER FOLLOWING AN ECHOCARDIOGRAPHIC ASSESSMENT WITH NO ABNORMAL FINDINGS. FOUR MONTHS AFTER TAVR, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH WORSENING CONGESTIVE HEART FAILURE AND A FEVER OF UNKNOWN CAUSE. TRANSTHORACIC AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY IDENTIFIED MILD MITRAL REGURGITATION ORIGINATING FROM AN ANTERIOR MITRAL LEAFLET DISSECTION WITH A LARGE PSEUDOANEURYSM, WITH AN ENTRY SITE AT THE LEVEL OF THE VENTRICULAR SURFACE OF THE ANTERIOR MITRAL CUSP (POSTERIOR WALL OF THE LEFT VENTRICULAR OUTFLOW TRACT) NEXT TO THE DISTAL EDGE OF THE EVOLUT PRO. NO VEGETATIONS OR HEMODYNAMIC DYSFUNCTION OF THE EVOLUT PRO WERE DETECTED. BLOOD CULTURES WERE TAKEN, AND ANTIBIOTIC THERAPY WAS INITIATED FOR HIGH SUSPICION OF ENDOCARDITIS. THE CULTURES DID NOT IDENTIFY CAUSAL MICROORGANISMS. ULTIMATELY, A GENITOURINARY TRACT INFECTION CAUSED BY ESCHERICHIA COLI WAS RECOGNIZED AS THE SOURCE OF THE FEVER. DESPITE INITIAL IMPROVEMENT, THE PATIENT DEVELOPED SEVERE MITRAL REGURGITATION AND REFRACTORY HEART FAILURE AND DIED SEVEN DAYS AFTER ADMISSION TO THE HOSPITAL. ANATOMOPATHOLOGICAL RESULTS REVEALED SEVERE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIFICATION AND A SUBANNULAR WALL DISRUPTION WITH IRREGULAR BORDERS NEXT TO THE DISTAL EDGE OF THE EVOLUT PRO. A PERMEABLE TUNNEL-SHAPE STRUCTURE THROUGH THE MITRAL-AORTIC JUNCTION CONNECTED THIS WALL DISRUPTION WITH THE ANTERIOR MITRAL LEAFLET CAUSING AN EXTENSIVE LEAFLET DISSECTION WITH A LARGE PSEUDOANEURYSM. THE AUTHORS NOTED THAT THEY SUSPECT THE LOWER EDGE OF THE EVOLUT PRO FRAME MAY HAVE CAUSED AN INITIALLY CONTAINED RUPTURE AT THE CALCIFIED LVOT FOLLOWING THE BALLOON POST-DILATION, WHICH SUBSEQUENTLY LED TO A SLOW AND PROGRESSIVE EXTENSION THROUGH THE MITRAL-AORTIC JUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280736 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-26

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Life Threatening| H| D