BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK

    MDR report key: 15396680 · Received September 9, 2022

    Report

    Report Number
    2025587-2022-02497
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    February 10, 2021
    Report Date
    September 9, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: PHANICHARAN S.; ET AL. TRANSCATHETER VALVE IMPLANTATION IN A SEVERELY REGURGITANT APICOAORTIC CONDUIT. JACC CARDIOVASC INTERV. 2021 MAR 22;14(6):E53-E56. DOI: 10.1016/J.JCIN.2020.12.012. PMID: (B)(4). EPUB 2021 FEB 10 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: HANCOCK VALVED CONDUIT (PMA# P790007, PRODUCT CODE: LWR). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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 VIA LITERATURE REGARDING A 33-YEAR-OLD FEMALE PATIENT WITH CONGENITAL BICUSPID AORTIC STENOSIS AND LEFT VENTRICULAR OUTFLOW RESTRICTION WHO UNDERWENT SURGICAL AORTIC VALVE REPLACEMENT USING A 21-MM MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS IN 2005. FURTHER CORRECTION OF CONGENITAL HEART DISEASE WAS PERFORMED IN 2006 USING A 22-MM MEDTRONIC HANCOCK VALVED CONDUIT TO CREATE AN ¿APICOAORTIC¿ CONDUIT FOR ADDITIONAL PASSAGE OF BLOOD FLOW FROM THE LEFT VENTRICLE TO THE DESCENDING AORTA (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). FURTHER REVISION SURGERY ON THE HANCOCK CONDUIT WAS PERFORMED IN 2009. FOR TEN-PLUS YEARS, THE PATIENT WAS CLINICALLY STABLE, BUT THEN DEVELOPED HEART FAILURE. THE PATIENT WAS HOSPITALIZED AND CARDIAC MAGNETIC RESONANCE IMAGING (MRI) REVEALED SEVERE MIXED AORTIC STENOSIS/REGURGITATION (AS/AR) WITHIN THE HANCOCK CONDUIT. AS SHE WAS CONSIDERED A HIGH-RISK SURGICAL CANDIDATE, THE PATIENT INSTEAD UNDERWENT VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT (VIV TAVR) USING A 22-MM MEDTRONIC MELODY BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBER NOT PROVIDED). THE PATIENT EXPERIENCED IMMEDIATE IMPROVEMENT WITH NO RESIDUAL REGURGITATION AND DID WELL ON 6-WEEK FOLLOW-UP. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139967 HANCOCK HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION HC150-12

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Hospitalization| L| R 21-MM FREESTYLE AORTIC VALVE.