BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS DCS

    MDR report key: 11388476 · Received February 26, 2021

    Report

    Report Number
    2025587-2021-00702
    Event Type
    Injury
    Date Received
    February 26, 2021
    Date of Event
    February 23, 2021
    Report Date
    June 23, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000207854
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: 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. REVIEW OF THE RETURNED ANGIOGRAPHIC IMAGES SHOWED A VALVE LOAD CHECK CONFIRMING A MISLOAD WITH AN OVERLAP PAST THE 4TH NODE. ANOTHER VALVE LOAD CHECK CONFIRMING A GOOD LOAD. THE VALVE DEPLOYED TO 80% TRENDING GOOD ON THE NON-CORONARY CUSP (NCC) SIDE. THE VALVE WAS DEPLOYED AT 80% IN THE LEFT ANTERIOR OBLIQUE (LAO) VIEW AND TRENDING GOOD. THE VALVE SNARED TO THE ASCENDING AORTA LOCATION. A VALVE LOAD CHECK CONFIRMING A GOOD LOAD ON THE SECOND VALVE. THE SECOND SYSTEM PASSED THROUGH THE FIRST SYSTEM AS A GOOD STARTING POINT. THE SECOND SYSTEM WAS DEPLOYED TO 80% AND TRENDING DEEP. THE SECOND SYSTEM DEPLOYED TO 100%. IN SUMMARY, THE IMAGING PROVIDED CONFIRMS THE FIRST VALVE SYSTEM WAS SNARED UP TO THE ASCENDING AORTA AND THERE IS NO IMAGING SHOWING THE NOSECONE CAUSED THE DISLODGEMENT. A SECOND SYSTEM WAS LOADED AND IMPLANTED BELOW THE FIRST VALVE SYSTEM. THE COMPUTED TOMOGRAPHY (CT) IMAGE PROVIDED CONFIRMS A SEVERE TORTUOSITY IS PRESENT IN THE PATIENT ROOT ANATOMY. THIS EVENT DOES NOT INDICATE DEVICE MISUSE OR MALFUNCTION. TRENDS FOR THIS EVENT TYPE HAVE BEEN ASSESSED AND HAVE BEEN REVIEWED IN THE PRODUCT QUALITY MEETING (PQM) AND NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. UPDATED DATA: METHOD AND RESULTS CODES. 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

    CONCLUSION: THE SUBJECT DELIVERY CATHETER SYSTEM (DCS) WAS NOT RETURNED FOR ANALYSIS. HOWEVER, IMAGES WERE RECEIVED FOR REVIEW. THE IMAGES SHOW THAT THERE WERE THREE VALVE LOAD CHECKS FOR THIS EVENT CONFIRMING TWO MISLOADS AND ONE GOOD LOAD. THE IMAGING PROVIDED CONFIRMS THE FIRST VALVE SYSTEM WAS SNARED UP TO THE ASCENDING AORTA. THERE WERE NO IMAGES SHOWING THE NOSECONE CAUSED THE MIGRATION. A SECOND SYSTEM WAS LOADED AND IMPLANTED BELOW THE FIRST VALVE SYSTEM. THE COMPUTED TOMOGRAPHY (CT) IMAGE PROVIDED CONFIRMS A SEVERE TORTUOSITY WAS PRESENT IN THE PATIENT ROOT ANATOMY. POTENTIAL FACTORS THAT CAN INFLUENCE DISLODGEMENT INCLUDE TENSION APPLIED ON THE DCS DURING POSITIONING, CALCIFICATION LEVELS AND SHAPE OF THE NATIVE ANATOMY. IN THIS CASE, IT WAS NOTED THAT THE PATIENT PRESENTED WITH SEVERE TORTUOSITY. THIS INDICATES THAT THE PROBABLE CAUSE OF THE DISLODGEMENT WAS PATIENT ANATOMY. HOWEVER, WITH THE LIMITED INFORMATION AVAILABLE AN ASSIGNABLE ROOT CAUSE FOR THE DISLODGEMENT CANNOT BE DETERMINED AND A RELATIONSHIP TO THE DCS COULD NOT BE ESTABLISHED. DISLODGEMENT EVENTS DO NOT TYPICALLY INDICATE A DEVICE MALFUNCTION OR A FAILURE TO MEET MANUFACTURING SPECIFICATIONS. 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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DELIVERY CATHETER SYSTEM (DCS) WAS DISCARDED. PRODUCT ANALYSIS: THE DCS WAS DISCARDED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. UPDATED: H6 CORRECTED: E1 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

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: EVPROPLUS-29US, SERIAL #: (B)(4), UBD: 17-JUN-2022, UDI#: (B)(4), PRODUCT ANALYSIS: THE PRODUCT WAS NOT RETURNED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCTS, 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, IT WAS REPORTED THAT THERE WAS ANATOMICAL TORTUOSITY. THE VALVE WAS SUCCESSFULLY IMPLANTED AT A DEPTH OF 3 AND 8 MM. UPON WITHDRAWAL OF THE DELIVERY CATHETER SYSTEM (DCS), THE NOSE CONE CAUGHT THE OUTFLOW STRUT OF THE VALVE AND DISLODGED THE VALVE INTO THE ASCENDING AORTA. THE NOSE CONE REMAINED STUCK BETWEEN THE STRUTS DUE TO THE BIAS OF THE CATHETER RELATED TO THE AORTIC ARCH AND THE AORTIC TORTUOSITY. THE DCS WAS FREED AND REMOVED. SUBSEQUENTLY, A SNARE WAS USED ON THE OUTFLOW PADDLE OF THE VALVE AND A SECOND VALVE WAS ADVANCED THROUGH THE FIRST AND SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281312 EVOLUT PRO PLUS DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVPROP2329US 0010382844 00763000207854

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention