BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 8161978 · Received December 13, 2018

    Report

    Report Number
    2025587-2018-03419
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 16, 2018
    Report Date
    March 5, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: CINE FILMS, ECHOCARDIOGRAPHIC IMAGES, AND COMPUTED TOMOGRAPHY (CT) SCAN WERE REVIEWED. THE CINE FILMS CONFIRMED THE FOL LOWING: WHEN THE VALVE WAS DEPLOYED AT 80%, IT WAS A DEEP IMPLANT. THE VALVE WAS FULLY RELEASED AND THE ANGIOGRAM SHOWED THAT THE VALVE WAS DEEP WITH SIGNIFICANT AORTIC INSUFFICIENCY (AI). A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED AND THE AI REMAINED. A NON-MEDTRONIC VALVE WAS IMPLANTED VALVE-IN-VALVE INSIDE THE VALVE AND THE AI DECREASED SIGNIFICANTLY. THE ECHOCARDIOGRAM IMAGES CONFIRMED A DEEP IMPLANT. THE CT SCAN CONFIRMED THAT THERE WAS A MODERATE AMOUNT OF CALCIUM PRESENT, EXTENDING INTO THE LEFT VENTRICLE. NO COMMENTS REGARDING THE PATIENT¿S TORTUROUS ANATOMY COULD BE MADE FROM THE SCANS PROVIDED. THE REPORTED AI CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, CALCIFICATION LEVEL OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. THE AI WAS LIKELY ATTRIBUTED TO THE SUBOPTIMAL (DEEP) POSITIONING OF THE VALVE SINCE IT WAS REPORTED THAT THE VALVE SLIPPED (DISLODGED) TOWARDS THE VENTRICLE. POTENTIAL FACTORS THAT CAN INFLUENCE A VALVE TO DISLODGE INCLUDE TENSION APPLIED ON THE DELIVERY CATHETER SYSTEM (DCS) DURING POSITIONING, CALCIFICATION LEVELS IN THE NATIVE VESSEL, OR COMPLIANCE OF THE AORTA AND NATIVE VESSELS. IT WAS ALSO CONFIRMED BY THE CINE REVIEW THAT THE VALVE WAS DEEP AFTER DEPLOYMENT AND SIGNIFICANT AI WAS PRESENT. BASED ON THE CINE REVIEW, THE CAUSE OF THE VALVE DISLODGEMENT AND AI COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THERE IS NO INDICATION OF A POTENTIAL MANUFACTURING ISSUE, DEVICE MISUSE OR A QUALITY DEFICIENCY. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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

    PRODUCT ANALYSIS: THE VALVE REMAINS IMPLANTED THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: CONCLUSION: WITHOUT 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 PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PRE-IMPLANT BALLOON AORTIC VAL VULVOPLASTY (BAV) WAS PERFORMED. FOLLOWING IMPLANT, THE VALVE SLIPPED DOWNWARDS INTO THE VENTRICLE CAUSING SEVERE AORTIC INSUFFICIENCY (AI). A BAV WAS PERFORMED AND IMPROVED THE AI. TO PREVENT SEVERE AI, THE PHYSICIAN DECIDED TO IMPLANT A SECOND 29MM VALVE, VALVE-I N-VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999466 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-29

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention