BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7939645 · Received October 5, 2018

    Report

    Report Number
    2025587-2018-02662
    Event Type
    Death
    Date Received
    October 5, 2018
    Date of Event
    September 13, 2018
    Report Date
    March 24, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00643169792340
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE DEVICE HISTORY RECORD WAS NOT REQUIRED AS THE EVENT DESCRIPTION DID NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. HOWEVER, MANUFACTURING CONTROLS ARE IN PLACE TO ENSURE THAT THE DEVICE MET SPECIFICATION REQUIREMENTS PRIOR TO RELEASE FROM THE MANUFACTURING FACILITY. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. PARAVALVULAR LEAK (PVL) CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. POTENTIAL FACTORS THAT CAN INFLUENCE A DISLODGED VALVE INCLUDE TENSION APPLIED ON THE DEVICE DURING POSITIONING, CALCIFICATION LEVELS IN THE NATIVE VESSEL, COMPLIANCE OF THE AORTA AND NATIVE VESSELS, AND OTHERS, AND IN THIS CASE, IT WAS REPORTED THAT THE BALLOON AORTIC VALVULOPLASTY (BAV) SEEMED TO DISLODGE THE DEVICE SLIGHTLY AORTIC AFTER THE BAV, WITH THE PVL INCREASING. DISLODGE EVENTS ARE TYPICALLY NOT RELATED TO A DEVICE MALFUNCTION. IT WAS REPORTED THAT THE PATIENT¿S ANNULAR PERIMETER AND DIAMETER WERE OUTSIDE THE DEVICE INSTRUCTIONS FOR USE (IFU) RECOMMENDATIONS FOR A 34MM VALVE; THIS EVENT IS CONSIDERED OFF LABEL USAGE. HOWEVER, BASED ON THE REPORT THAT THE PATIENT¿S ANNULUS WAS OUTSIDE THE IFU RECOMMENDATIONS, THE DISLODGEMENT OF BOTH VALVES IS MOST LIKELY RELATED TO THE IMPROPER SIZING BETWEEN VALVE AND ANNULUS. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS PER DEVICE IFU. A PROCEDURE- OR VALVE-RELATED DEATH IS AN INHERENT RISK WHEN THE PATIENT CONDITION IS SUCH THAT A PERCUTANEOUS AORTIC VALVE (PAV) IS NEEDED TO SUSTAIN CARDIAC FUNCTION, AND IT CAN OCCUR DESPITE AN IDEAL IMPLANT PROCEDURE OR DEVICE FUNCTIONALITY. THERE WAS NO INDICATION THAT A MALFUNCTION OR MISUSE CONTRIBUTED TO THE REPORTED EVENTS. 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 · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF DEATH WAS HEMODYNAMIC COMPROMISE AS A RESULT OF THE DISLODGED VALVE. HOWEVER, THE PHYSICIAN CHOSE TO TREAT THE PATIENT WITH PALLIATIVE MEASURES VERSUS A REDO STERNOTOMY. AN AUTOPSY WAS NOT PERFORMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: E VOLUTR-34-US, SERIAL/LOT #: (B)(4), UBD: 16-JAN-2020, UDI#: (B)(4). PRODUCT ANALYSIS: THE VALVES REMAIN IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM TRANSCATHETER BIOPROSTHETIC VALVE, UPON DEPLOYMENT, MODERATE-SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 30X4 SEMI-COMPLIANT BALLOON. POST BAV, THE VALVE APPEARED TO HAVE DISLODGED SLIGHTLY AORTIC INCREASING THE PVL. SUBSEQUENTLY, A SECOND 34MM VALVE WAS IMPLANTED. DURING REMOVAL OF THE PIGTAIL CATHETER, THE VALVE DISLODGED. THE PATIENT WAS PLACED ON THE PALLIATIVE CARE PROTOCOL. IT WAS REPORTED THE PATIENT WAS TRANSFERRED OUT OF THE OPERATING ROOM WITH AN AGONAL HEART RHYTHM AND WAS NOT EXPECTED TO SURVIVE THE DAY TO DUE HEMODYNAMIC DECLINE. IT WAS REPORTED THAT DURING THE PRE-CASE MEETING IT WAS NOTED THAT THE PATIENT¿S ANNULAR PERIMETER AND DIAMETER WERE OUTSIDE OF INSTRUCTIONS FOR USE (IFU) RECOMMENDATIONS FOR A 34MM VALVE. THE PHYSICIANS DECIDED TO PROCEED WITH IMPLANT DUE TO A POSSIBLE FUSED RIGHT CORONARY CUSP (RCC) AND LEFT CORONARY CUSP (LCC) RAPHE, AND POSSIBLE SMALLER PERIMETER JUST ABOVE THE NATIVE ANNULUS. IT WAS ALSO REPORTED THE BILATERAL COMMON ILIAC ARTERIES WERE MILDLY CALCIFIED. THE PATIENT DIED LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781133 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-34-US 00643169792340

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death