BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3/SAPIEN DELIVERY SYSTEM

    MDR report key: 2882503 · Received December 20, 2012

    Report

    Report Number
    2015691-2012-18910
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED AS IT WAS INDICATED THAT IT WAS DISCARDED BY THE SITE. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. THE IFU AND THE RF3 TRAINING MANUAL INSTRUCT THE OPERATOR TO INFLATE THE BALLOON DURING THE SIZING PORTION OF THE PREPARATION PROCEDURE. ANY RUPTURES OR DAMAGE TO THE BALLOON IS HIGHLY DETECTABLE PRIOR TO THE INSERTION OF THE DEVICE INTO THE PATIENT. HISTORICAL THV BALLOON RUPTURE COMPLAINTS HAVE BEEN ANALYZED BY EDWARDS AND SUMMARIZED IN A TECHNICAL SUMMARY (TS). THE TS PROVIDES A RATIONALE AS TO WHY IT IS VERY UNLIKELY THAT A PRODUCT MALFUNCTION CONTRIBUTES TO THIS TYPE OF EVENT, INCLUDING FACTORS ON WHY DEPLOYMENT OF BALLOONS ON THV DELIVERY SYSTEMS ARE SUBJECT TO INCREASED RISK OF BURST IN A CALCIFIED ANNULUS (OPEN CELL IMPINGEMENT AND STRESS CONCENTRATION AGAINST CALCIUM NODULES), AS WELL AS OUTLINING THE EXTENSIVE MANUFACTURING MITIGATIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, LEAK TESTING, AND FUNCTIONAL BALLOON BURST TESTING THAT OCCURS WITH EVERY MANUFACTURED LOT) . ANALYSIS REVEALED THAT THESE TYPES OF RUPTURES ARE TYPICALLY CAUSED BY PUNCTURE FROM CALCIUM ON THE NATIVE AORTIC VALVE. IN THIS CASE, THE VALVE/VALVE LEAFLETS WERE EXTREMELY CALCIFIED. 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 OF EVENT 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

    THE DEVICE WAS NOT RETURNED AS IT WAS INDICATED THAT IT WAS DISCARDED BY THE SITE. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. THE IFU AND THE RF3 TRAINING MANUAL INSTRUCT THE OPERATOR TO INFLATE THE BALLOON DURING THE SIZING PORTION OF THE PREPARATION PROCEDURE. ANY RUPTURES OR DAMAGE TO THE BALLOON IS HIGHLY DETECTABLE PRIOR TO THE INSERTION OF THE DEVICE INTO THE PATIENT. ALL OF THE ABOVE WORK ORDERS DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO REPORTED COMPLAINT. A REVIEW OF PRODUCT VERIFICATION (PV) SAMPLE DATA FROM THE AFFECTED WORK ORDER REVEALED THAT ALL SAMPLES PASSED THE BALLOON INFLATION/DEFLATION TEST, BALLOON FATIGUE AND BURST TEST PER SOP4751. HISTORICAL THV BALLOON RUPTURE COMPLAINTS HAVE BEEN ANALYZED BY EDWARDS AND SUMMARIZED IN A TECHNICAL SUMMARY (TS). THE TS PROVIDES A RATIONALE AS TO WHY IT IS VERY UNLIKELY THAT A PRODUCT MALFUNCTION CONTRIBUTES TO THIS TYPE OF EVENT, INCLUDING FACTORS ON WHY DEPLOYMENT OF BALLOONS ON THV DELIVERY SYSTEMS ARE SUBJECT TO INCREASED RISK OF BURST IN A CALCIFIED ANNULUS (OPEN CELL IMPINGEMENT AND STRESS CONCENTRATION AGAINST CALCIUM NODULES), AS WELL AS OUTLINING THE EXTENSIVE MANUFACTURING MITIGATIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, LEAK TESTING, AND FUNCTIONAL BALLOON BURST TESTING THAT OCCURS WITH EVERY MANUFACTURED LOT) . ANALYSIS REVEALED THAT THESE TYPES OF RUPTURES ARE TYPICALLY CAUSED BY PUNCTURE FROM CALCIUM ON THE NATIVE AORTIC VALVE. IN THIS CASE, THE VALVE/VALVE LEAFLETS WERE EXTREMELY CALCIFIED. 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 OF EVENT 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

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THE DELIVERY SYSTEM BALLOON BURST UPON FULL INFLATION OF THE SAPIEN VALVE. THE FIRST SAPIEN VALVE (REF. MDR/MFR REPORT #2015691-2012-18908) MOVED AORTIC DURING DEPLOYMENT TO A 90:10 POSITION. THIS RESULTED IN SEVERE PARAVALVULAR LEAK (PVL) REQUIRING A SECOND VALVE. DURING DEPLOYMENT OF THE 2ND SAPIEN VALVE, UPON FULL INFLATION, THE DELIVERY SYSTEM BALLOON RUPTURED. THE VALVE WAS POST-DILATED WITH A ZMED BALLOON AND FINAL PVL WAS MILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROFLEX 3/SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23 59311312

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention