BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA 3 INTRODUCER SHEATH SET

    MDR report key: 3802831 · Received May 9, 2014

    Report

    Report Number
    2015691-2014-01097
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, CONDUCTION SYSTEM INJURIES (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 TECHNICAL SUMMARY WRITTEN BY EDWARDS, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TAVR 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, 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, THE EXACT CAUSE OF THE CHB CANNOT BE CONFIRMED. HOWEVER, IN ADDITION TO THE PROCEDURE ITSELF, THE PATIENT¿S PRE-EXISTING RBBB, LIKELY CONTRIBUTED TO THE EVENT OR PUT THE PATIENT AT HIGHER RISK FOR THE DEVELOPMENT OF CHB DURING THIS PROCEDURE. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    DURING A TRANSAPICAL TAVR PROCEDURE, POST INSERTION OF THE SHEATH, THE PATIENT DEVELOPED COMPLETE HEART BLOCK (CHB). THE PATIENT REQUIRED A TEMPORARY PACEMAKER DURING THE REMAINDER OF THE PROCEDURE AND A PERMANENT PACEMAKER WAS IMPLANTED POST PROCEDURE. OF NOTE, THE PATIENT HAD AN EXISTING RIGHT BUNDLE BRANCH BLOCK (RBBB).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280883 ASCENDRA 3 INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120IS 59656477

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention