BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 5961290 · Received September 19, 2016

    Report

    Report Number
    2025587-2016-01490
    Event Type
    Injury
    Date Received
    September 19, 2016
    Date of Event
    August 1, 2016
    Report Date
    October 26, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LUC JGY ET AL. TRANSCATHETER VALVE-IN-VALVE, A CAUTIONARY TALE. ANN THORAC SURG 2016;102:E211¿3. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. 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 · 1

    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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE OF AN (B)(6) MALE PATIENT WITH SEVERE AORTIC STENOSIS AND CORONARY ARTERY DISEASE WHO UNDERWENT AORTIC ROOT REPLACEMENT WITH IMPLANT OF A MEDTRONIC 29-MM FREESTYLE STENTLESS BIOPROSTHESIS (SERIAL NUMBER NOT PROVIDED). FOUR YEARS LATER THE PATIENT PRESENTED WITH SEVERE DYSPNEA. TRANSESOPHAGEAL ECHOCARDIOGRAPHY REVEALED A DEGENERATING BIOPROSTHESIS WITH A RUPTURED CUSP RESULTING IN SEVERE AORTIC REGURGITATION. GIVEN THE PATIENT¿S AGE, COMORBIDITIES, AND PATENT BYPASS GRAFTS, TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WAS CHOSEN AS TREATMENT. A NON-MEDTRONIC 29-MM TRANSCATHETER AORTIC VALVE WAS SUCCESSFULLY DEPLOYED VALVE-IN-VALVE IN EXCELLENT POSITION, HOWEVER, BEGAN TO EMBOLIZE DISTALLY TOWARD THE AORTA SOON AFTERWARD. IN AN EFFORT TO CORRECT THE VALVE POSITION THE BALLOON WAS REINFLATED AND THE NON-MEDTRONIC VALVE PULLED DOWN INTO THE FREESTYLE BIOPROSTHESIS ANNULUS BUT THEN MIGRATED DOWNWARD INTO THE LEFT VENTRICLE. THE PATIENT WAS EMERGENTLY CONVERTED TO AN OPEN HEART STERNOTOMY IN WHICH THE NON-MEDTRONIC VALVE WAS EASILY RETRIEVED. INTRAOPERATIVE FINDINGS REVEALED NO OBVIOUS RUPTURE OR ABNORMALITIES IN THE ANNULUS OR THE FREESTYLE SEWING RING, HOWEVER THE INNER DIMENSION WAS GROSSLY DILATED TO 30 MM IN DIAMETER WHICH WAS MUCH LARGER THAN THE 27-MM INTERNAL DIAMETER ANTICIPATED. A CONVENTIONAL AORTIC VALVE REPLACEMENT WAS PERFORMED WITH ANOTHER NON-MEDTRONIC VALVE SUCCESSFULLY IMPLANTED INSIDE THE FREESTYLE BIOPROSTHESIS. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY AND AFTER AN UNEVENTFUL POSTOPERATIVE COURSE WAS DISCHARGED HOME ON POSTOPERATIVE DAY 13. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PHYSICIAN/AUTHOR PROVIDED THE PATIENT'S WEIGHT OF (B)(6) KG, AND ATTRIBUTED THE OBSERVED ADVERSE EFFECTS TO THE RUPTURED CUSP OF THE MEDTRONIC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610961 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995CS29

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R