BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 5229514 · Received November 17, 2015

    Report

    Report Number
    2015691-2015-03107
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    October 27, 2015
    Report Date
    October 27, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    RESULT: KNOWN INHERENT RISK OF PROCEDURE. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. THE NOVAFLEX+ DELIVERY SYSTEM WAS RETURNED TO EDWARDS FOR EVALUATION. VISUAL INSPECTION REVEALED A LONGITUDINAL AND RADIAL TEAR ON THE BALLOON AND THE BALLOON INSERT WAS OBSERVED TO BE BENT OUTWARDS. DIMENSIONAL ANALYSIS OF THE BALLOON WALL THICKNESS WAS PERFORMED AT DIFFERENT LOCATIONS ALONG THE BALLOON TEAR. ALL MEASUREMENTS MET SPECIFICATIONS. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. CASE IMAGING REVIEW REVEALED HEAVY CALCIFICATION ON THE UPPER TIP OF THE VALVE IMPACTING THE BALLOON DURING DEPLOYMENT. DURING MANUFACTURING, THE DELIVERY SYSTEM BALLOON UNDERGOES MULTIPLE 100% INSPECTIONS AND VERIFICATIONS. THESE INSPECTIONS SUPPORT THAT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE WAS THE SOURCE OF THE COMPLAINT. TRANSCATHETER DELIVERY BALLOON BURST COMPLAINTS HAVE BEEN PREVIOUSLY INVESTIGATED BY EDWARDS AND DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES. A DETAILED ROOT CAUSE ANALYSIS REVEALED THAT IT IS VERY UNLIKELY THAT A PRODUCT DEFECT CONTRIBUTES TO THIS TYPE OF EVENT. THERE ARE EXTENSIVE MANUFACTURING INSPECTIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, LEAK TESTING, AND FUNCTIONAL BALLOON BURST TESTING PERFORMED TO EVERY MANUFACTURED LOT). THE THV DELIVERY SYSTEM BALLOONS ARE SUBJECT TO INCREASED RISK OF BURST DUE TO CONTACT WITH A HIGHLY CALCIFIED ANNULUS. ANALYSIS REVEALED THAT THESE TYPES OF RUPTURES ARE TYPICALLY CAUSED BY PUNCTURE FROM CALCIUM ON THE NATIVE AORTIC VALVE WHEN THE INFLATED DELIVERY SYSTEM BALLOON COMES IN CONTACT WITH THE NATIVE ANNULAR CALCIFICATION AT FULL INFLATION/DEPLOYMENT. IN THIS CASE, THE COMPLAINTS OF THE DELIVERY SYSTEM BALLOON RUPTURE AND WITHDRAWAL DIFFICULTIES WERE CONFIRMED BASED ON THE CONDITION OF THE RETURNED DEVICE; HOWEVER, NO MANUFACTURING NON-CONFORMITIES WERE IDENTIFIED IN THE RETURNED SAMPLE. THE DIMENSIONAL INSPECTION OF THE DELIVERY SYSTEM REVEALED THE WALL THICKNESS WAS WITHIN SPECIFICATION. A DEFINITE ROOT CAUSE FOR THE DELIVERY SYSTEM BALLOON RUPTURE CANNOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, PROCEDURAL FACTORS (1ML ADDITIONAL VOLUME ADDED TO THE DEVICE) AND PATIENT FACTORS (HEAVY CALCIFICATION ON THE UPPER LIP OF THE DEPLOYED VALVE) LIKELY CONTRIBUTED TO THIS EVENT. 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 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 OUR EDWARDS CANADIAN AFFILIATE, DURING A VALVE-IN-VALVE PROCEDURE (A 23MM SAPIEN XT VALVE IN A PRE-EXISTING BIOMECHANICAL PULMONIC VALVE) THE NOVAFLEX+ DELIVERY SYSTEM (DS) BALLOON RUPTURED WHEN FULLY INFLATED. THE SAPIEN XT VALVE AND DS WERE PREPPED WITH 1CC ADDITIONAL VOLUME AND POSITIONED ACROSS THE PRE-EXISTING BIOPROSTHETIC IN THE PULMONARY POSITION. DURING DEPLOYMENT UNDER RAPID PACING, AS THE VALVE WAS SLOWLY INFLATED TO THE MAXIMUM VOLUME, THE DS BALLOON RUPTURED. THE VALVE WAS DEPLOYED IN A GOOD POSITION AND WAS STABLE. SIGNIFICANT DIFFICULTY WAS ENCOUNTERED DURING THE REMOVAL OF THE DS. IT APPEARED TO BE CAUGHT ON THE DEPLOYED VALVE. AFTER MANIPULATION OF THE FLEX CATHETER, THE DS WAS ABLE TO PASS THROUGH THE DEPLOYED VALVE. FURTHER DIFFICULTIES WERE ENCOUNTERED WITHDRAWING THE DS THROUGH THE SHEATH. ADDITIONAL MANIPULATION WAS REQUIRED TO BRING THE DS INTO THE SHEATH. ULTIMATELY, THE DS AND SHEATH WERE REMOVED TOGETHER. THERE WAS NO APPARENT VASCULAR INJURY. THE FEMORAL VEIN WAS CLOSED AND COMPRESSED WITH NO BLEEDING REPORTED. IT WAS SPECULATED THAT THE HEAVY CALCIFICATION ON THE UPPER LIP OF THE DEPLOYED VALVE, IN COMBINATION WITH THE ADDITIONAL VOLUME IN THE DS, MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE.

    Description of Event or Problem · 1

    AS REPORTED BY OUR EDWARDS CANADIAN AFFILIATE, DURING A VALVE-IN-VALVE PROCEDURE (A 23MM SAPIEN XT VALVE IN A PRE-EXISTING MITROFLOW 25MM 2000 BIOPROSTHETIC PULMONIC VALVE) THE NOVAFLEX+ DELIVERY SYSTEM (DS) BALLOON RUPTURED WHEN FULLY INFLATED. THE SAPIEN XT VALVE AND DS WERE PREPPED WITH 1CC ADDITIONAL VOLUME AND POSITIONED ACROSS THE PRE-EXISTING BIOPROSTHETIC IN THE PULMONARY POSITION. DURING DEPLOYMENT UNDER RAPID PACING, AS THE VALVE WAS SLOWLY INFLATED TO THE MAXIMUM VOLUME, THE DS BALLOON RUPTURED. THE VALVE WAS DEPLOYED IN A GOOD POSITION AND WAS STABLE. SIGNIFICANT DIFFICULTY WAS ENCOUNTERED DURING THE REMOVAL OF THE DS. IT APPEARED TO BE CAUGHT ON THE DEPLOYED VALVE. AFTER MANIPULATION OF THE FLEX CATHETER, THE DS WAS ABLE TO PASS THROUGH THE DEPLOYED VALVE. FURTHER DIFFICULTIES WERE ENCOUNTERED WITHDRAWING THE DS THROUGH THE SHEATH. ADDITIONAL MANIPULATION WAS REQUIRED TO BRING THE DS INTO THE SHEATH. ULTIMATELY, THE DS AND SHEATH WERE REMOVED TOGETHER. THERE WAS NO APPARENT VASCULAR INJURY. THE FEMORAL VEIN WAS CLOSED AND COMPRESSED WITH NO BLEEDING REPORTED. IT WAS SPECULATED THAT THE HEAVY CALCIFICATION ON THE UPPER LIP OF THE DEPLOYED VALVE, IN COMBINATION WITH THE ADDITIONAL VOLUME IN THE DS, MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760562 EDWARDS NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS23 60083876

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention