BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 7656619 · Received July 2, 2018

    Report

    Report Number
    2015691-2018-02582
    Event Type
    Injury
    Date Received
    July 2, 2018
    Date of Event
    April 1, 2015
    Report Date
    June 7, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TREATED BETWEEN APRIL 2015 AND SEPTEMBER 2017. THE TYPE OF VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE PMA NUMBERS FOR THE SAPIEN XT (P130009) AND SAPIEN 3 (P140031) VALVES. THE DEPLOYMENT POSITION IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE CODES NPU (MITRAL) AND NPT (AORTIC). THE VALVES WERE NOT RETURNED TO EDWARDS LIFESCIENCES AS THEY REMAIN IMPLANTED IN THE PATIENT¿S. PER THE INSTRUCTIONS FOR USE (IFU), CONDUCTION SYSTEM DEFECTS (HEART BLOCK) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON VALVULOPLASTY, DEPLOYMENT OF THE PROSTHETIC VALVE, AND THE OVERALL TVR PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE TVR PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY, WRITTEN BY EDWARDS LIFESCIENCES, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PRE-OPERATIVE COMORBID STATUS, THE DEGREE AND BULKINESS OF 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 SURGERY, 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, TVR MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING TVR OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. IN THIS CASE, THERE WAS NO INDICATION A PRODUCT DEFICIENCY 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. BIBLIOGRAPHY: PRAZ, FABIEN, ET AL. "TRANSATRIAL IMPLANTATION OF A TRANSCATHETER HEART VALVE FOR SEVERE MITRAL ANNULAR CALCIFICATION." THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY (2018).

    Additional Manufacturer Narrative · 1

    REF. RELATED MFGR. REPORT NUMBERS: 2015691-2018-02559, 2015691-2018-02560, 2015691-2018-02578, 2015691-2018-02579, 2015691-2018-02582, 2015691-2018-02584, 2015691-2018-02586.

    Description of Event or Problem · 1

    AS REPORTED THROUGH A JOURNAL ARTICLE TITLED, "TRANSATRIAL IMPLANTATION OF A TRANSCATHETER HEART VALVE FOR SEVERE MITRAL ANNULAR CALCIFICATION" POST TVR PROCEDURE WHILE IN THE HOSPITAL (EXACT DATES UNKNOWN), 2 PATIENTS DEVELOPED CONDUCTION DISORDERS AND WERE IMPLANTED WITH A PERMANENT PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496551 EDWARDS SAPIEN TRANSCATHETER HEART VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention