BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

    MDR report key: 7117271 · Received December 14, 2017

    Report

    Report Number
    2015691-2017-04278
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    June 6, 2014
    Report Date
    November 23, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE SAPIEN XT (9300TFX) OR SAPIEN 3 (9600TFX) VALVE WAS IMPLANTED, THEREFORE THE INFORMATION TO BOTH IS BEING PROVIDED. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE OR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE. MODEL #/LOT # 9300TFX OR 9600TFX. THE 9300TFX (PMA P130009) OR 9600TFX (PMA P140031). INVESTIGATION IS ONGOING. BIBLIOGRAPHY: UNZUÉ, LEIRE, ET AL. "OUTCOMES OF PATIENTS AT ESTIMATED LOW SURGICAL RISK UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION WITH BALLOON-EXPANDABLE PROSTHESES." CARDIOVASCULAR REVASCULARIZATION MEDICINE (2017).

    Additional Manufacturer Narrative · 1

    REF. MFG REPORT NUMBERS: 2015691-2017-04275, 2015691-2017-04276, 2015691-2017-04277, 2015691-2017-04278, 2015691-2017-04279.

    Additional Manufacturer Narrative · 1

    THE VALVES WERE NOT RETURNED TO EDWARDS FOR EVALUATION AS THEY REMAIN IMPLANTED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL CASE INFORMATION WERE MADE, HOWEVER, THE INFORMATION WAS NOT FORTHCOMING. PER THE INSTRUCTIONS FOR USE (IFU), CONDUCTION SYSTEM DEFECTS (HEART BLOCK) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY, DEPLOYMENT OF THE PROSTHETIC VALVE, AND THE OVERALL TAVR 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 PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE TAVR PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TAVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PRE-OPERATIVE COMORBID 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, TAVR MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TAVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING TAVR 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 DEVICE MALFUNCTION CONTRIBUTED TO THESE ADVERSE EVENTS. THE CAUSE OF THE CONDUCTION DISORDERS IS UNKNOWN, HOWEVER, MAY BE DUE TO PATIENT FACTORS (NOT PROVIDED) OR THE MECHANISMS DESCRIBED ABOVE. 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 ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS AFFILIATE IN EUROPE, A JOURNAL ARTICLE TITLED, "OUTCOMES OF PATIENTS AT ESTIMATED LOW SURGICAL RISK UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION WITH BALLOON-EXPANDABLE PROSTHESES" REPORTED THAT POST TAVR PROCEDURE (DATES UNKNOWN) IN THE AORTIC POSITION, THREE PATIENT REQUIRED A PACEMAKER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896188 AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention