BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3211127 · Received July 8, 2013

    Report

    Report Number
    2015691-2013-20554
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RETURNED TO EDWARDS FOR EVALUATION IN USED CONDITION. THE ATRION SYRINGES USED IN THE CASE WERE ALSO RETURNED. THE DELIVERY SYSTEMS WERE VISUALLY INSPECTED FOR ANY DEFECTS AT THE BALLOON AS WELL AS ALONG THE ENTIRE LENGTH OF THE CATHETER. NO ABNORMALITIES/DEFECTS WERE OBSERVED IN ALL OF THE RETURNED DEVICES. THE DELIVERY SYSTEMS WERE THEN PREPPED USING THE RETURNED ATRION SYRINGES. A PRELIMINARY INFLATION/DEFLATION TEST REVEALED THAT THE TOTAL INFLATION/DEFLATION TIME FOR EACH DEVICE WAS WITHIN MANUFACTURING SPECIFICATIONS. BOTH DEVICES COULD BE INFLATED AND DEFLATED USING THE RETURNED ATRION SYRINGES WITH NO DIFFICULTIES OBSERVED. BALLOON INFLATION/DEFLATION TEST WAS PERFORMED ON THE RETURNED DEVICES USING THE RETURNED ATRION SYRINGES. THE RESULTS MET MANUFACTURING SPECIFICATIONS FOR THE TOTAL TIME TO INFLATE AND DEFLATE THE BALLOON. THERE WERE NO DIFFICULTIES OBSERVED TO INFLATE OR DEFLATE THE BALLOONS. THE DELIVERY SYSTEMS¿ BALLOONS WERE INFLATED TO MEASURE THE BALLOON¿S OUTER DIAMETER AT 0 SECONDS, 3 SECONDS (TIME FOR BALLOON TO EQUILIBRATE WITH THE SYRINGE), AND AGAIN AT 20 SECONDS. NO DIFFICULTIES WERE OBSERVED. ALL BALLOONS DIAMETERS MEET MANUFACTURING SPECIFICATIONS. THE COMPLAINTS REGARDING INFLATION/DEFLATION DIFFICULTY WERE NOT CONFIRMED ON ANY OF THE RETURNED DEVICES. THE RETURNED DELIVERY SYSTEMS WAS INFLATED AND DEFLATED WITH THE RETURNED ATRION SYRINGES WITHOUT ANY ISSUE. NO ABNORMALITIES WERE OBSERVED DURING INFLATION/DEFLATION AND INFLATION/DEFLATION TIME MET SPECIFICATION. EVALUATION OF THE RETURNED DEVICES REVEALED NO MANUFACTURING NON-CONFORMANCE THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DURING MANUFACTURING, THE DELIVERY SYSTEM UNDERGOES TWO 100% INSPECTIONS AS FOLLOWS: THE BALLOON IS INFLATED TO ENSURE PROPER SIZE AND INSPECTED FOR MECHANICAL DAMAGE THE BALLOON COMPONENT IS LEAKED TESTED AFTER THE Y-CONNECTOR IS BONDED THESE INSPECTIONS SUPPORT THAT IT IS HIGHLY UNLIKELY THAT A PRE-EXISTING OCCLUSION OR A MANUFACTURING NONCONFORMANCE WAS THE SOURCE OF THE COMPLAINT. ACCESSORIES USED DURING THE CASE SUCH AS STOPCOCKS, AND OTHER SYRINGES WERE NOT RETURNED FOR EVALUATION. THESE DEVICES MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. MALFUNCTION/DAMAGE OF ACCESSORIES COULD CAUSE OCCLUSION OF THE LUMEN OR ALLOW AIR INTO THE SYSTEM WHICH BOTH CAN RESULT IN INABILITY/DIFFICULTY TO DEFLATE THE BALLOON. OTHER PROCEDURAL FACTORS CAN ALSO CONTRIBUTE TO INCREASED INFLATION/DEFLATION TIME. IF AN INCORRECT CONTRAST/SALINE RATIO IS USED DURING PREPPING OF THE DEVICE IT CAN LEAD TO AN INCREASED VISCOSITY OF THE CONTRAST SOLUTION. THIS INCREASED VISCOSITY CAN LEAD TO DIFFICULTY INFLATING/DEFLATING AND LONGER INFLATION/DEFLATION TIME. TO PREVENT THIS FROM OCCURRING, THE INSTRUCTIONS FOR USE (IFU) STATE THAT A 15:85 CONTRAST TO HEPARINIZED SALINE SOLUTION SHOULD BE USED FOR PREPPING THE DELIVERY SYSTEM. THE COMPLAINT COULD NOT BE CONFIRMED, AND NO IFU/TRAINING INADEQUACIES WERE IDENTIFIED. ALTHOUGH REVIEW OF COMPLAINT HISTORY FOR THE MONTH OF JUNE 2013 REVEALED THAT THE OCCURRENCE RATE EXCEEDS THE CONTROL LIMITS FOR THESE FAILURE MODES, SINCE A MANUFACTURING NON-CONFORMANCE WAS NOT IDENTIFIED AND THE COMPLAINT COULD NOT BE CONFIRMED, NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING DEVICE PREP, DIFFICULTY WAS ENCOUNTERED WHEN ATTEMPTING TO DEFLATE THE DELIVERY SYSTEM BALLOON. DIFFICULTY INFLATING THE BALLOON WITH THE 60CC SYRINGE WAS ALSO NOTED. AFTER SEVERAL ATTEMPTS TO RE-INFLATE AND DEFLATE THE BALLOON, THE DEVICE WAS DISCARDED AND NOT USED. IT WAS CONFIRMED WITH THE PERSON PREPPING THE DEVICES THAT THE CONTRAST DILUTION WAS 85:15%, WITH 15CC OF CONTRAST AND 85CC OF HEPARINIZED SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310954 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9100BCL26 59491361

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR