BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2823439 · Received November 8, 2012

    Report

    Report Number
    2015691-2012-18618
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S AGE WAS UPDATED PER INFORMATION RECEIVED FROM THE EDWARDS IMPLANT REGISTRY. PMA NUMBER WAS UPDATED PER RECENT AMENDMENTS TO THIS DEVICE'S PMA.

    Additional Manufacturer Narrative · 1

    IN THIS CASE, A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED AS THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. PER THE SAPIEN VALVE INSTRUCTIONS FOR USE (IFU) AND THE THV TRAINING GUIDE, VALVE MALPOSITION AND PARAVALVULAR LEAK ARE KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. PARAVALVULAR LEAK CAN OCCUR AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE WHICH CAN OCCUR DUE TO UNEVEN DISTRIBUTION OF CALCIUM. 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, PATIENT AND PROCEDURAL FACTORS APPEAR TO HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. PER THE INFORMATION RECEIVED FROM THE EDWARDS CLINICAL SPECIALIST, THE PATIENT'S AORTIC VALVE AND LEAFLETS WERE HEAVILY CALCIFIED, IMAGE INTENSIFIER ANGLE WAS NOT OPTIMAL AND DESPITE PROPER INITIAL POSITIONING OF THE VALVE PRE-DEPLOYMENT, THE VALVE MOVED DURING THE DEPLOYMENT RESULTING IN A 70:30 POSITION. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THE SAPIEN TRANSCATHETER HEART VALVE WAS DEPLOYED TOO AORTIC (70:30 WITHIN THE ANNULUS) AND THERE WAS 3+ PARAVALVULAR LEAK. A SECOND SAPIEN VALVE WAS DEPLOYED RESOLVING THE PARAVALVULAR LEAK. PER REPORT, THE RIGHT FEMORAL ARTERY WAS ACCESSED VIA PERCUTANEOUS APPROACH AND WAS PRE-CLOSED WITH 3 PERCLOSE DEVICES. THE NATIVE AORTIC VALVE WAS SEVERELY CALCIFIED AND THERE WAS MODERATED LEAFLET CALCIFICATION. THE IMAGE INTENSIFIER ANGLE WAS INACCEPTABLE; ALL THREE SINUSES WHERE IN A COPLANAR VIEW. THE VALVE WAS PLACED IN A 50:50 POSITION AND WAS DEPLOYED UNDER RAPID RV PACING WITHOUT INCIDENT. THERE WAS GOOD CAPTURE WITH A SYSTOLIC BLOOD PRESSURE UNDER 50MMHG. THE ATRION SYRINGE WAS COMPLETELY EMPTIED AND FULL DEPLOYMENT WAS HELD FOR A COUNT OF FIVE SECONDS. THE VALVE MOVED DURING DEPLOYMENT TO A 70:30 AORTIC POSITION WITH A 3+ PARAVALVULAR LEAK. THE DECISION WAS MADE TO POST DILATE THE VALVE; POST DILATION REDUCED THE LEAK TO 2+. AFTER GREAT DISCUSSION A SECOND WAS DEPLOYED IN THE CORRECT 50:50 ANNULAR POSITION AND NO RESIDUAL LEAK. THERE WAS A POST CASE CONFERENCE WITH THE IMPLANTING PHYSICIANS, THE DISCUSSION REVEALED THERE WAS NOTHING DIFFERENT THAT COULD HAVE BEEN DONE TECHNICALLY. WITH THE FORESHORTENING OF THE VALVE AND HEAVY CALCIUM BURDEN THE VALVE DID NOT SEAT INTO THE PREDETERMINED VALVE POSITION.

    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 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention