BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER

    MDR report key: 3243740 · Received July 23, 2013

    Report

    Report Number
    2015691-2013-20661
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 AN EDWARDS¿S TECHNICAL SUMMARY: ¿CLINICAL TECHNICAL SUMMARY FOR COMPLAINTS-CONDUCTION DISTURBANCES/ HEART BLOCK¿, 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 CAUSE FOR THE REPORTED AV BLOCK EXPERIENCED BY THE PATIENT AFTER BAV APPEARS TO BE RELATED TO A COMBINATION OF PATIENT AND PROCEDURAL FACTORS. PER REPORT, THIS PATIENT HAD A PRE-EXISTING HISTORY OF RBBB AND LEFT ANTERIOR FASCICULAR BLOCK AND IT APPEARS THE CONDUCTION SYSTEM WAS FURTHER IMPACTED DURING BALLOON VALVULOPLASTY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. 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

    PER REPORT, DURING A TRANSAPICAL TAVR PROCEDURE THE PATIENT HAD NO UNDERLYING RHYTHM AFTER THE BAV WAS PERFORMED. THE TEMPORARY PACEMAKER RATE WAS SET AT 80 BPM. DURING THE VALVE DEPLOYMENT THE PACING RATE WAS INCREASED TO 180 BPM. THE VALVE WAS DEPLOYED WITH NO ISSUES. POST DEPLOYMENT, THE PATIENT STILL HAD NO UNDERLYING RHYTHM, SO THE TEMPORARY PACEMAKER RATE WAS SET BACK TO 80. AS THE PATIENT WAS PACEMAKER DEPENDANT, THE TEMPORARY PACEMAKER WAS LEFT IN PLACE POST PROCEDURE AT A RATE OF 80 BPM WITH A RESULTING BLOOD PRESSURE OF 82/41 MMHG. A PERMANENT PACEMAKER WAS PLACED ON THE NEXT DAY. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342274 ASCENDRA BALLOON AORTIC VALVULOPLASTY CATHETER AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BAVC

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention