BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 18653107 · Received February 6, 2024

    Report

    Report Number
    2025587-2024-00659
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    November 10, 2021
    Report Date
    February 6, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID ENVPRO-16; PRODUCT LOT/SERIAL NUMBER (B)(6); PRODUCT TYPE: DELIVERY CATHETER SYSTEM; PRODUCT ID L-ENVPRO-16; PRODUCT LOT/SERIAL NUMBER (B)(6); PRODUCT TYPE: COMPRESSION LOADING SYSTEM; SELECT PATIENT INFORMATION CANNOT BE DOCUMENTED IN THE REPORT DUE TO REGIONAL PRIVACY REGULATIONS. THE CODES PRESENT IN SECTION H6 CORRESPOND TO MULTIPLE COMPONENTS/PRODUCTS THAT COMPRISE THIS REPORTED EVENT. THIS REPORT WAS SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER (B)(4) AND CAPA 564121. 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 IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VIA RIGHT FEMORAL ARTERY ACCESS, AN ELECTROCARDIOGRAM (ECG) IDENTIFIED A NEW ONSET LEFT BUNDLE BRANCH BLOCK (LBBB) WITH AN INCREASED QRS DURATION. A BETA BLOCKER AND ASPIRIN WERE PROVIDED FOR THE LEFT BUNDLE BRANCH BLOCK (LBBB). THE LBBB HAD PROLONGED HOSPITALIZATION. BLEEDING AT THE ACCESS SITE ALSO OCCURRED WHICH REQUIRED THREE SUTURES. BASELINE HEMOGLOBIN MEASURED 13.4 GRAMS PER DECILITER (G/DL). FOUR DAYS FOLLOWING THE PROCEDURE THE HEMOGLOBIN MEASURED 10.8 G/DL. THE ACCESS SITE BLEEDING WAS REPORTED AS CAUSAL TO THE INLINE SHEATH OF THE DELIVERY CATHETER SYSTEM (DCS). FOUR DAYS FOLLOWING THE VALVE IMPLANT A PAROXYSMAL ATRIAL FIBRILLATION EPISODE OCCURRED. AN ANTI-ARRHYTHMIC WAS PROVIDED FOR THE ATRIAL FIBRILLATION AND THE ATRIAL FIBRILLATION RESOLVED THE SAME DAY. THE ACCESS SITE BLEED WAS REPORTED AS RESOLVED 5 DAYS FOLLOWING THE ONSET. AT DISCHARGE THE HEMOGLOBIN MEASURED 11.9 G/DL. ADDITIONALLY, 5 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE AFTER THE PATIENT RECEIVED AN ANTI-ARRHYTHMIC FOR THE ATRIAL FIBRILLATION (FA) THE PATIENT EXPERIENCED BILATERAL EYELID SWELLING. AN ANTIHISTAMINE WAS PROVIDED TO TREAT THIS REPORTED ORAL ALLERGEN SYNDROME. THE EVENT RESOLVED THE SAME DAY AS ONSET. THE PHYSICIAN INDICATED THIS WAS UNRELATED TO THE MEDTRONIC PRODUCTS AND PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503712 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-29

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization| R "SEE H10...."