BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2871306 · Received December 13, 2012

    Report

    Report Number
    2015691-2012-18835
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    May 22, 2012
    Report Date
    November 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE SAPIEN VALVE PULMONIC INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, PERIVALVULAR LEAK AND VALVE REGURGITATION ARE A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH PULMONIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. PHYSICIANS ARE EXTENSIVELY TRAINED BE EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. IN THIS CASE, THE CAUSE OF THE PULMONARY INSUFFICIENCY CANNOT BE CONFIRMED; HOWEVER, IN THE PHYSICIAN'S OPINION, THE INCIDENT MAY BE RELATED TO THE UNDER-EXPANSION OF THE VALVE DURING DEPLOYMENT. PER THE IFU WARNINGS, THE PRESENCE OF SEVERE STENOSIS WITH CONCENTRIC CALCIFICATION OF THE PULMONIC VALVE CONDUIT MAY NOT ALLOW SUITABLE CONDUIT DILATATION FOR PLACEMENT OF THE THV. THE PHYSICIAN'S TRAINING A MANUAL RECOMMENDS RE-INFLATING THE BALLOON IF THE EXPANSION OF THE SAPIEN VALVE IS NON-UNIFORM OR INCOMPLETE POST DEPLOYMENT. 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 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS ONGOING.

    Additional Manufacturer Narrative · 1

    CINE AND TEE IMAGES OF THE PROCEDURE WERE PROVIDED TO EDWARDS BY THE FACILITY FOR INTERNAL REVIEW. THE IMAGES WERE REVIEWED BY AN EDWARDS PHYSICIAN AND THE FOLLOWING OBSERVATIONS WERE MADE: CINE (B)(6) 2011: SELF EXPANDING STENT DEPLOYED IN THE PULMONARY ARTERY. SAPIEN VALVE DEPLOYED WITHIN THE SELF EXPANDING STENT. CANNOT CONFIRM ALLEGED UNDEREXPANSION OF VALVE ON IMAGES PROVIDED. CINE (B)(6) 2012: WORSENING PULMONIC INSUFFICIENCY PRESENT. ATTEMPTED BALLOON DILATATION. CINE (B)(6) 2014: BALLOON DILATATION. PULMONARY ARTERIOGRAM DEMONSTRATES SEVERE PULMONIC INSUFFICIENCY. VALVE IN VALVE PERFORMED. POST DEPLOYMENT ARTERIOGRAM DEMONSTRATES NO SEVERE PI. IMPRESSIONS: SEVERE PULMONARY INSUFFICIENCY, POSSIBLY DUE TO UNDER-SIZING, GROWTH OF THE PULMONARY ARTERY, NON-FUNCTIONING LEAFLET, OR PREMATURE STRUCTURAL VALVE DETERIORATION (SVD). THE PRESENCE OF A NON-FUNCTIONING LEAFLET CANNOT BE DETERMINED BY CINE ALONE. SIGNIFICANT GROWTH OVER A 3 YEAR PERIOD, SUFFICIENT TO CAUSE THIS DEGREE OF PULMONIC INSUFFICIENCY, IS NOT LIKELY. SVD OF THE SAPIEN TYPICALLY RESULTS IN STENOSIS, RATHER THAN PULMONIC INSUFFICIENCY. THE CAUSE OF THE PULMONARY INSUFFICIENCY CANNOT BE DETERMINED FROM THE IMAGES PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED: AFTER FOLLOW UP STUDY THE CAUSE OF THE CENTRAL LEAK COULD NOT BE CONFIRMED. IT WAS DECIDED TO IMPLANT A 2ND VALVE. A 26MM SAPIEN XT VALVE WAS SUCCESSFULLY IMPLANTED IN THE LEAKING SAPIEN VALVE.

    Description of Event or Problem · 1

    PER THE (B)(6) STUDY REPORT, THE PATIENT WAS FOUND TO HAVE SIGNIFICANT PULMONARY INSUFFICIENCY (PI) AT THE 1-YEAR FOLLOW UP VISIT AFTER A TRANSCATHETER PULMONIC VALVE REPLACEMENT PROCEDURE VIA A TRANSFEMORAL APPROACH. THE PATIENT WAS ASYMPTOMATIC BUT THE PHYSICIAN DECIDED TO TAKE THE PATIENT BACK TO THE CATH LAB FOR RE-EVALUATION. IN THE CATH LAB THE 26MM SAPIEN VALVE WAS POST-DILATED WITH ONLY A MINIMAL IMPROVEMENT IN THE PI. POST DEPLOYMENT, DURING THE INDEX PROCEDURE, THE 26MM SAPIEN VALVE HAD BEEN FOUND TO HAVE NO PARAVALVULAR LEAK AND MODERATE CENTRAL LEAK IN THE ECHOCARDIOGRAM. PER THE PHYSICIAN'S OPINION, THE BIOPROSTHESIS CENTRAL LEAK MAY BE DUE TO THE UNDER-EXPANSION OF THE 26MM SAPIEN VALVE DURING DEPLOYMENT. HOWEVER, THE CAUSE OF THE PI COULD NOT BE CONFIRMED. THE POST DILATION PROCEDURE WAS PERFORMED WITHOUT AN INTRACARDIAC OR TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PATIENT WAS NOTED TO BE BETTER THAT PRIOR TO THE PROCEDURE AS HE HAD FREE PI AT THAT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFXP26CL

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention