BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 14915955 · Received July 5, 2022

    Report

    Report Number
    2015691-2022-06623
    Event Type
    Injury
    Date Received
    July 5, 2022
    Date of Event
    April 26, 2021
    Report Date
    July 5, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SAVAS, GOKTUG, OZGUR KILIC, AND SAIT TERZI. ''PERCUTANEOUS CLOSURE OF AN IATROGENIC VENTRICULAR SEPTAL DEFECT ASSOCIATED WITH TRANSCATHETER AORTIC VALVE IMPLANTATION.'' TURK KARDIYOLOJI DERNEGI ARSIVI 50.1 (2022): 70. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIAL OR VALVULAR STRUCTURES ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE OVERALL THV PROCEDURE AND MAY REQUIRE INTERVENTION. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A THV PROCEDURE, INCLUDING PERFORATION BY THE GUIDEWIRE, THE DELIVERY SYSTEM, OR THE TRANSVENOUS PACER (TVP) LEAD. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. PER THE INSTRUCTIONS FOR USE (IFU), MEMBRANOUS VSD IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE EXACT CAUSE OF THE MEMBRANOUS VSD IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS ABOVE. 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. NO DEVICE RETURNED.

    Description of Event or Problem · 0

    THE MEDICAL ARTICLE, ''PERCUTANEOUS CLOSURE OF AN IATROGENIC VENTRICULAR SEPTAL DEFECT ASSOCIATED WITH TRANSCATHETER AORTIC VALVE IMPLANTATION'', WAS REVIEWED. AS REPORTED, THE PATIENT WAS ADMITTED WITH DYSPNEA. TAVI PROCEDURE WAS PERFORMED USING TRANSFEMORAL ACCESS. THE AORTIC VALVE WAS PRE-DILATED WITH A ZMED II VALVULOPLASTY BALLOON. A 29MM EDWARDS SAPIEN XT VALVE WAS DEPLOYED DURING RAPID VENTRICULAR PACING. POST-PROCEDURAL ECHOCARDIOGRAPHY SHOWED A WELL-SEATED AORTIC VALVE WITH MILD PARAVALVULAR LEAK, A PEAK TRANSVALVULAR GRADIENT OF 9MMHG, AND A NEW VSD ON THE MEMBRANOUS SEPTUM. THE DEFECT WAS 8MM IN SIZE, AND THERE WAS A SHUNT DIRECTED FROM THE LEFT TO THE RIGHT VENTRICLE. THE PATIENT SHOWED SYMPTOMATIC IMPROVEMENT AND WAS DISCHARGED HOME ON MEDICAL THERAPY AFTER FIVE DAYS. THREE WEEKS AFTER DISCHARGE, THEY WERE ADMITTED WITH SYMPTOMS SUGGESTIVE OF BIVENTRICULAR FAILURE (SHORTNESS OF BREATH AND PERIPHERAL EDEMA). THE TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED A MEMBRANOUS VSD, DILATATION OF THE RIGHT CHAMBERS WITH MODERATE TRICUSPID REGURGITATION, AND SYSTOLIC PULMONARY ARTERY PRESSURE OF 60 MM HG. THE PREVIOUSLY DEPLOYED AORTIC VALVE WAS NORMAL IN FUNCTION. THE DECISION TO PERFORM A PERCUTANEOUS VSD CLOSURE WAS MADE. THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY CONFIRMED THERE WAS NO RESIDUAL SHUNTING THROUGH THE DEVICE. THE PATIENT REPORTED PRONOUNCED IMPROVEMENT IN HIS SYMPTOMS AND WAS DISCHARGED HOME AFTER THREE DAYS. PATIENT REMAINED STABLE AT THE ONE-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398084 NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS29 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention