BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 12978858 · Received December 10, 2021

    Report

    Report Number
    2015691-2021-06767
    Event Type
    Injury
    Date Received
    December 10, 2021
    Date of Event
    November 17, 2021
    Report Date
    January 20, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINED IMPLANTED. THEREFORE, A NO PRODUCT RETURN ENGINEERING EVALUATION WAS PERFORMED. THE COMPLAINTS CENTRAL REGURGITATION PARAVALVULAR LEAK WERE CONFIRMED FROM THE MEDICAL RECORDS REVIEW . A REVIEW OF DHR AND LOT HISTORY WERE UNABLE TO BE PERFORMED AS THE VALVE SERIAL NUMBER WAS NOT PROVIDED FOR EVALUATION; HOWEVER, COMPLAINT HISTORY REVIEW DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NONCONFORMANCE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE IFU REVEALED NO DEFICIENCIES. DURING THE MANUFACTURING PROCESS, ALL SAPIEN 3 XT VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% TESTED FOR PROPER COAPTATION UNDER PHYSIOLOGICAL BACKPRESSURE CONDITIONS PRIOR TO RELEASE FOR DISTRIBUTION. THEREFORE, IT IS HIGHLY UNLIKELY THAT A MANUFACTURING DEFECT OR DEVICE MALFUNCTION CONTRIBUTED TO THE EVENT. IT SHOULD BE NOTED THAT THE THV WAS IMPLANTED IN TRICUSPID POSITION (VALVE-IN-RING) FOR THIS CASE. CURRENTLY, THE SAPIEN XT WITH NOVAFLEX+ DELIVERY SYSTEM WAS INDICATED FOR NATIVE AORTIC VALVE REPLACEMENT AND SURGICAL BIOPROSTHETIC AORTIC VALVE REPLACEMENT . DEPLOYMENT OF THE SAPIEN XT VALVE IN A TRICUSPID POSITION IS NOT INDICATED PER THE LABELING; THEREFORE THE DEVICE LABELING (IFUS AND TRAINING MANUALS) DO NOT INSTRUCT THE OPERATOR HOW TO POSITION THE SAPIEN XT VALVE IN THIS SCENARIO. AS REPORTED, 'A 29MM SAPIEN XT VALVE, IMPLANTED IN THE TRICUSPID POSITION FOR AN UNKNOWN IMPLANT DURATION, UNDERWENT A VALVE IN VALVE PROCEDURE DUE TO REGURGITATION AND PERIVALVULAR LEAK (PVL).' PER THE INSTRUCTIONS FOR USE (IFU), VALVE REGURGITATION IS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE VALVE. REGURGITATION WHICH DEVELOPS OVER TIME CAN BE DUE TO PATIENT RELATED FACTORS AND/OR STRUCTURAL VALVE DETERIORATION. ADDITIONALLY, PARAVALVULAR LEAK (PVL) IS ALSO A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE, AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. SOME PVL IS NOT UNCOMMON POST-DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. IN THIS CASE, THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT AND NO FURTHER INFORMATION WAS PROVIDED. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (DEPLOYMENT OF A SAPIEN XT VALVE INSIDE A TRICUSPID RING) MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. SINCE NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED; NO CORRECTIVE/PREVENTIVE ACTION NOR PRODUCT RISK ASSESSMENT (PRA) IS REQUIRED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION FROM A THV TERRITORY MANAGER THAT A PATIENT WITH A 29MM SAPIEN XT VALVE, IMPLANTED IN THE TRICUSPID POSITION FOR AN UNKNOWN IMPLANT DURATION, UNDERWENT A VALVE IN VALVE PROCEDURE DUE TO REGURGITATION AND PERIVALVULAR LEAK(PVL). A 29MM SAPIEN 3 VALVE WAS IMPLANTED. THE PATIENT WAS NOTED TO BE IN RECOVERY AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872291 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX29A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention