BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVEO PRO DELIVERY SYSTEM

    MDR report key: 17837408 · Received September 28, 2023

    Report

    Report Number
    2025587-2023-03917
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    September 14, 2023
    Report Date
    October 9, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID EVOLUTR-26; PRODUCT LOT/SERIAL NUMBER F200469; PRODUCT TYPE: TRANSCATHETER HEART VALVES; IMPLANT DATE NA; EXPLANT DATE NA PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. 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 RECEIVED ADDITIONAL INFORMATION THAT CHANGED THE EVENT DESCRIPTION AND DEVICE RELATEDNESS OF THIS PREVIOUSLY REPORTED EVENT. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY AS THE DEVICE NEVER ENTERED THE PATIENT. UPDATED DATA: B5 - EVENT DESCRIPTION H6 - PATIENT, DEVICE, RESULT AND CONCLUSION CODES ADDITIONAL CODES - IMF HEALTH IMPACT CODE 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 THAT DURING THE VALVE-IN-VALVE (VIV) IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INSIDE A NON-MEDTRONIC SURGICAL VALVE (TRIFECTA), A SEVERE ASCENDING AORTIC ANEURYSM/PERFORATION/DISSECTION WAS IDENTIFIED. THE CAUSE OF THE DISSE CTION WAS NOT REPORTED. IT WAS NOTED THAT THE VALVE WAS ALREADY LOADED. COMPUTED TOMOGRAPHY (CT) ANALYSIS HAD BEEN PERFORMED BY A PHYSICIAN BUT FAILED TO DEMONSTRATE THE "ANATOMICAL OBVIOUSNESS". THE TEAM DISCUSSED THE CASE AND DECIDED TO SWITCH THE LOADED MEDTRONIC VALVE TO A NON-MEDTRONIC (SAPIEN 23MM) VALVE BECAUSE OF THE LOWER FRAME. THE LOADED DCS AND VALVE WERE DISCARDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IMPLANT OF THE VALVE, PER THE PHYSICIAN, THE CAUSE OF THE SEVERE ASCENDING AORTIC ANEURYSM/PERFORATION/DISSECTION WAS DUE TO THE PREVIOUS SURGICAL VALVE REPLACEMENT. THE DELIVERY CATHETER SYSTEM (DCS) WAS NOT ATTEMPTED TO BE POSITIONED AS THE DISTANCE FROM THE SEVERE ASCENDING AORTIC ANEURYSM/PERFORATION/DISSECTION TO THE OUTFLOW PART OF THE VALVE WAS TOO SHORT AND THE RISK WAS TOO HIGH WHICH COULD RESULT IN A PROBLEM FOR THE FUTURE. THE SEVERE ASCENDING AORTIC ANEURYSM/PERFORATION/DISSECTION WAS IDENTIFIED IN THE OPERATING ROOM UNDER ANGIOGRAPHY. THE DELIVERY CATHETER SYSTEM (DCS) NEVER ENTERED THE PATIENT. CONSERVATIVE TREATMENT WAS PROVIDED AS THE PATIENT REFUSED SURGICAL CARE OF THE SEVERE ASCENDING AORTIC ANEURYSM/PERFORATION/DISSECTION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231106 ENVEO PRO DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION ENVPRO-14 0011645147

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention SEE H10 ...