BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER, 20MM

    MDR report key: 18669099 · Received February 8, 2024

    Report

    Report Number
    2015691-2024-00841
    Event Type
    Injury
    Date Received
    February 8, 2024
    Date of Event
    June 1, 2014
    Report Date
    February 8, 2024
    Manufacturer
    EDWARD LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS 1 OF 6 BEING SUBMITTED FOR THIS COMPLAINT. REFERENCE MFG. REPORT NO. 2015691-2024-00839, 2015691-2024-00843, 2015691-2024-00844, 2015691-2024-00846, AND 2015691-2024-00854.

    Additional Manufacturer Narrative · 0

    BIBLIOGRAPHY: LEE, SEUNG-AH, ET AL. "IDENTIFICATION OF CT-DERIVED INTERNAL AREA IN FAILED SURGICAL STENTED BIOPROSTHESES FOR VALVE-IN-VALVE IMPLANTATION." RADIOLOGY: CARDIOTHORACIC IMAGING 5.6 (2023): E230103. PER THE INSTRUCTIONS FOR USE (IFU), CORONARY FLOW OBSTRUCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE. THE IFU CAUTIONS THAT SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED FOR PATIENTS WITH BULKY CALCIFIED AORTIC VALVE LEAFLETS NEAR CORONARY OSTIA. IN ADDITION, IT WARNS THAT CAUTION SHOULD BE EXERCISED IN IMPLANTING A BIOPROSTHESIS IN PATIENTS WITH CLINICALLY SIGNIFICANT CORONARY ARTERY DISEASE. CORONARY OBSTRUCTION CAN RESULT IN MYOCARDIAL ISCHEMIA OR INFARCTION DUE TO OBSTRUCTION OF THE CORONARY BLOOD FLOW AND MAY REQUIRE INTERVENTION (E.G., PERCUTANEOUS CORONARY INTERVENTION (PCI). MULTIPLE PATIENT FACTORS COULD PUT THE PATIENT AT RISK FOR CORONARY FLOW OBSTRUCTION DURING THE THV PROCEDURE, INCLUDING SIGNIFICANT UNDERLYING CORONARY ARTERY DISEASE AND BULKY CALCIFICATION OF THE NATIVE LEAFLETS AND ROOT. DISPLACEMENT OF CALCIUM DEPOSITS WITH EMBOLIZATION OF DEBRIS INTO ONE OF THE ARTERIES, OR AORTIC DISSECTION WITH CONTINUITY OF THE RUPTURE INTO THE INTIMA OF ONE OF THE CORONARY OSTIA, CAN RESULT IN THIS COMPLICATION. ADDITIONALLY, MINIMAL DISTANCE BETWEEN THE NATIVE ANNULUS AND THE CORONARY OSTIA, BULKY CALCIFICATION, LONG NATIVE LEAFLETS, AND OBLITERATED CORONARY SINUSES. PROCEDURAL FACTORS SUCH AS TORN NATIVE LEAFLET DURING BALLOON VALVULOPLASTY, PLAQUE SHIFT, DEPLOYMENT OF THE BIOPROSTHETIC HEART VALVE TOO AORTIC, AND SIGNIFICANT VALVE OVER SIZING COULD ALSO CONTRIBUTE TO THIS COMPLICATION. THE EDWARDS THV TRAINING MANUALS ADVISE THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE, ROOT, AND CORONARY ANATOMY. PHYSICIANS ARE EXTENSIVELY TRAINED BY BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES. THE PHYSICIAN IS INSTRUCTED TO EVALUATE THIS RISK EARLY IN THE PATIENT SCREENING PROCESS IN ALL PATIENTS THE FOLLOWING FACTORS SHOULD BE CONSIDERED: DEGREE OF CALCIFICATION ON LEAFLETS, ANNULUS TO CORONARY OSTIA DISTANCE, LENGTH OF THE VALVE LEAFLET, WIDTH OF THE VALSALVA SINUSES, MOVEMENT OF THE LEAFLETS DURING BAV, PATENCY OF CORONARIES DURING BAV, AND EXPANDED HEIGHT OF THE INTENDED THV. THE TRAINING MANUALS ALSO PROVIDE THE FOLLOWING TIPS FOR DETECTING RISK FOR LEFT MAIN OCCLUSION: (1) AORTOGRAM OR TEE BEFORE THV IMPLANTATION TO REVEAL BULKY CALCIFIED LEAFLETS; (2) DURING PRE-DILATATION, NOTE BULKY CALCIFICATION ON VALVE MOVING TOWARDS OSTIUM ON LEFT MAIN; AND (3) CONSIDER AORTOGRAM DURING VALVULOPLASTY TO ASSESS CORONARY FLOW. THE EDWARDS THV MANUALS ALSO ADVISE THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE, ROOT, AND CORONARY ANATOMY. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. OTHER POTENTIAL CONTRIBUTING FACTORS ARE UNKNOWN AS LIMITED CLINICAL INFORMATION WAS PROVIDED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. H3 OTHER TEXT: NO VALVE TO BE RETURNED.

    Description of Event or Problem · 0

    AS REPORTED THROUGH A PROSPECTIVE SINGLE CENTER STUDY FROM A EUROPEAN JOURNAL ARTICLE, "IDENTIFICATION OF CT-DERIVED INTERNAL AREA IN FAILED SURGICAL STENTED BIOPROSTHESES FOR VALVE-IN-VALVE IMPLANTATION". THE STUDY WAS FROM JUNE 2014 TO DECEMBER 2022 OF 28 CONSECUTIVE PARTICIPANTS WHO UNDERWENT A VALVE-IN-VALVE (VINV) PROCEDURE. THE PARTICIPANTS WHO UNDERWENT VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT, HYPOATTENUATING INTRA-ANNULAR MATERIAL WITHIN THE FAILED SURGICAL BIOPROSTHESIS REDUCED THE CT-DERIVED INTERNAL AREA AND INTERFERED WITH EXPANSION OF INTRA-ANNULAR POSITIONED IMPLANTED VALVES, LEADING TO POSTPROCEDURAL PATIENT-PROSTHESIS MISMATCH. THIS EVENT IS FOR AN 81-YEAR-OLD FEMALE WITH A 20MM SAPIEN 3 VALVE DEVELOPED MODERATE PATIENT-PROSTHESIS MISMATCH (PPM) AND LEFT CORONARY ARTERY OSTEAL OBSTRUCTION AFTER VINV PROCEDURE. A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. THERE WAS NO INTERVENTION DUE TO THE PPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366108 EDWARDS SAPIEN 3 TRANSCATHETER, 20MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARD LIFESCIENCES 9600TFX20

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention