BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC HALL PROSTHETIC HEART VALVE

    MDR report key: 13026563 · Received December 17, 2021

    Report

    Report Number
    2025587-2021-03770
    Event Type
    Death
    Date Received
    December 17, 2021
    Date of Event
    February 1, 1988
    Report Date
    December 17, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWQ
    PMA / PMN Number
    P790018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MASTERS RG, ET AL. EXTRINSIC OBSTRUCTION OF THE MEDTRONIC-HALL DISK VALVE IN THE MITRAL POSITION. ANN THORAC SURG. 1988 FE B;45(2):210-2. DOI: 10.1016/S0003-4975(10)62440-X. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT AND DATE OF DEATH: FEBRUARY 1, 1988 (MONTH AND YEAR VALID). 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THREE CASES OF EXTRINSIC OBSTRUCTION OF THE MEDTRONIC-HALL PROSTHESIS IN THE MITRAL POSITION. PATIENT 1: A (B)(6) FEMALE PATIENT WHO UNDERWENT MITRAL VALVE REPLACEMENT WITH A 29 MM MEDTRONIC-HALL MECHANICAL VALVE USING AN INTERRUPTED MATTRESS SUTURE TECHNIQUE OF ETHIBOND BUTTRESSED WITH TEFLON PLEDGETS. THE VALVE SEATED WELL, WITH FREE MOVEMENT OF THE DISK OCCLUDER. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY. HOWEVER, DURING CLOSURE OF THE STERNOTOMY, HYPOTENSION OCCURRED WITH ELECTROMECHANICAL DISSOCIATION, NECESSITATING REINSTITUTION OF CARDIOPULMONARY BYPASS. THE LEFT ATRIUM WAS RE-OPENED, AND THE DISK OCCLUDER WAS FOUND TO BE FIRMLY STUCK IN THE CLOSED POSITION. ONE SUTURE HAD TORN THROUGH THE FRIABLE ANTEROLATERAL MITRAL ANNULUS AND WAS OVERHANGING AND HAD BECOME LODGED BETWEEN THE VALVE RING AND DISK, JAMMING THE VALVE IN THE CLOSED POSITION. THE DISK WAS RELEASED MANUALLY, AND THE VALVE WAS RE-SUTURED WITH CONSIDERABLE DIFFICULTY. DESPITE INTRA-AORTIC BALLOON COUNTER-PULSATION AND DOPAMINE THERAPY, THE PATIENT COULD NOT BE WEANED FROM CARDIOPULMONARY BYPASS. THE AUTHORS DID NOT EXPLICITLY STATE THE PATIENT¿S OUTCOME, BUT BASED ON THE GIVEN CIRCUMSTANCES, IT IS LIKELY THE PATIENT DIED. PATIENT 2: A (B)(6) FEMALE PATIENT WHO UNDERWENT MITRAL VALVE REPLACEMENT WITH A 29 MM MEDTRONIC-HALL MECHANICAL VALVE. ALTHOUGH THE VALVE DISK MOVED FREELY, DURING CLOSURE A SUDDEN DROP IN BLOOD PRESSURE OCCURRED WITH ELECTROMECHANICAL DISSOCIATION. THE LEFT ATRIUM BECAME NOTICEABLY DISTENDED. CARDIOPULMONARY BYPASS WAS REINITIATED, AND THE ATRIUM WAS RE-OPENED. THE TIP OF THE POSTEROMEDIAL PAPILLARY MUSCLE WAS WEDGED BETWEEN THE DISK AND VALVE RING, LOCKING THE VALVE IN THE CLOSED POSITION. THE VALVE WAS OPENED MANUALLY, AND THE PAPILLARY MUSCLE WAS DEBRIDED. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY AND WAS DISCHARGED TWELVE DAYS LATER. PATIENT 3: A (B)(6) FEMALE PATIENT WHO UNDERWENT MITRAL VALVE REPLACEMENT WITH A 31 MM MEDTRONIC-HALL MECHANICAL VALVE. THE VALVE DISK WAS SEEN TO MOVE FREELY, AND THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY. DURING CLOSURE OF THE STERNOTOMY, RECURRENT EPISODES OF ELECTROMECHANICAL DISSOCIATION WERE NOTED. WITH A NORMAL ELECTROCARDIOGRAM, THERE WERE RECURRENT EPISODES OF CESSATION OF LEFT VENTRICULAR EJECTION FOLLOWED BY SPONTANEOUS RECOVERY. CARDIOPULMONARY BYPASS WAS REINITIATED, AND THE ATRIUM WAS OPENED. THE TIP OF THE POSTEROMEDIAL PAPILLARY MUSCLE WAS FOUND TO LAY ON THE VALVE RING, CAUSING INTERMITTENT LOCKING OF THE DISK AGAINST THE RING. THE PAPILLARY MUSCLE WAS DEBRIDED, RESULTING IN A NORMALLY FUNCTIONING VALVE. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS AND WAS SUBSEQUENTLY DISCHARGED AFTER AN UNEVENTFUL HOSPITAL COURSE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923961 MEDTRONIC HALL PROSTHETIC HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC HEART VALVES DIVISION M7700

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| L| D