BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 17167691 · Received June 20, 2023

    Report

    Report Number
    2015691-2023-14048
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    August 1, 2015
    Report Date
    June 20, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE ARTICLE OKAJIMA, KAZUE, IKKI KOMATSU, AND TODD B. SETO. LOW INCIDENCE OF PROSTHESIS-PATIENT MISMATCH FOLLOWING EXTREMELY SMALL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH 20-MM SAPIEN 3. INTERNATIONAL JOURNAL OF ANGIOLOGY 31.02 (2021): 120-125. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM AUGUST 2015 TO DECEMBER 2017. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-AUGUST 2015) WAS USED AS THE OCCURRENCE DATE. PER THE INSTRUCTIONS FOR USE (IFU), CONDUCTION SYSTEM DEFECTS (HEART BLOCK), ARRHYTHMIAS AND CONDUCTION SYSTEM DEFECTS THAT MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY, BIOPROSTHETIC HEART VALVES, AND THE THV PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY EXPLAIN THESE COMPLICATIONS OF THE THV PROCEDURE. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN EW CLINICAL TECHNICAL SUMMARY FOR COMPLAINTS-CONDUCTION DISTURBANCES/ HEART BLOCK, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER THV ARE ASSOCIATED WITH MANY PATIENT-RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PRE-OPERATIVE CO-MORBID STATUS, THE DEGREE, AND BULKINESS OF AORTIC VALVE AND ANNULAR CALCIFICATION, INTER-VENTRICULAR SEPTAL THICKNESS, PRE-EXISTING ELECTROCARDIOGRAM ABNORMALITIES, THE DEPTH OF PROSTHESIS IMPLANTATION, AND THE PROFILE OF THE IMPLANTED PROSTHESIS. UNLIKE CONVENTIONAL AVR, WHERE THERE MAY BE LOCALIZED TRAUMA DUE TO DECALCIFICATION OF THE ANNULUS AND/OR SUTURE PLACEMENT IN THE PROXIMITY OF THE AV NODE OR THE BUNDLES, THV MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER THV ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING THV OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST THE CAUSE OF THE EVENT IS UNKNOWN. 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 AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, PER ARTICLE, "LOW INCIDENCE OF PROSTHESIS-PATIENT MISMATCH FOLLOWING EXTREMELY SMALL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH 20-MM SAPIEN 3'', THE STUDY INCLUDES A TOTAL OF 201 PATIENTS WHO WERE TREATED WITH SAPIEN 3 VALVE (SP3) FROM AUGUST 2015 TO DECEMBER 2017 AT THE QUEENS MEDICAL CENTER, HONOLULU, HI. THE STUDY INCLUDED 21 PATIENTS WITH 20MM SAPIEN 3 VALVES, 67 WITH 23MM SAPIENT 3 VALVES, AND 113 WITH 26 OR 29MM SAPIEN 3 VALVES. EVENTS WERE CAPTURED FROM TABLE 2 PROCEDURAL OUTCOMES AND TABLE 3 HEMODYNAMIC PARAMETERS (POSTPROCEDURAL). THIS EVENT IS FOR AFTER IMPLANTATION OF A 20MM SAPIEN 3 VALVE, ONE PATIENT HAD A NEW PACE MAKER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013953 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX20A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention