BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT STANDARD AORTIC HEART VALVE

    MDR report key: 15633753 · Received October 19, 2022

    Report

    Report Number
    2025587-2022-02852
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    July 20, 2022
    Report Date
    October 19, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HOPFGARTEN ET AL. SPONTANEOUS CORONARY ARTERY DISSECTION AND PAPILLARY MUSCLE RUPTURE IN PATIENT WITH UNDIAGNOSED VASCULAR EHLER-DANLOS SYNDROME. JACC CASE REP. 2022 JUL 20;4(14):902-905. DOI: 10.1016/J.JACCAS.2022.05.004. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. 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 61-YEAR-OLD FEMALE PATIENT WHO UNDERWENT IMPLANT OF A 29-MM MEDTRONIC ATS OPEN PIVOT MECHANICAL MITRAL VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED).  WEANING FROM CARDIOPULMONARY BYPASS, DECANNULATION, AND ADMINISTRATION OF PROTAMINE SULFATE WAS UNEVENTFUL.  HOWEVER, DURING THE FINAL STAGE OF THE OPERATION THE LARGE BRACHIOCEPHALIC VEIN RUPTURED WITH PROFUSE BLEEDING REQUIRING MULTIPLE SUTURES.  THE POSTOPERATIVE PERIOD WAS COMPLICATED WITH ATRIAL FIBRILLATION, THE NEED FOR PERMANENT PACEMAKER IMPLANTATION, PNEUMOTHORAX TREATMENT, AND PROLONGED ANTIBIOTIC THERAPY.  THE PATIENT REQUIRED FIVE DAYS IN THE INTENSIVE CARE UNIT AND WAS FINALLY DISCHARGED 23 DAYS AFTER SURGERY IN GOOD CONDITION.  NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047014 OPEN PIVOT STANDARD AORTIC HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC HEART VALVES DIVISION 500FA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention| L| H