BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EWDARDS NOVAFLEX+ DELIVERY SYSTEM

    MDR report key: 4405356 · Received January 9, 2015

    Report

    Report Number
    2015691-2015-00060
    Event Type
    Injury
    Date Received
    January 9, 2015
    Date of Event
    December 16, 2014
    Report Date
    December 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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.THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE AND BALLOON SEPARATION FOLLOWING BALLOON RUPTURE ARE POTENTIAL RISKS OF THE TAVR PROCEDURE. THE PHYSICIAN TRAINING MANUALS RECOMMEND THAT THE USER NOT USE EXCESSIVE FORCE WHEN REMOVING THE BALLOON IF THE INFLATION BALLOON BURSTS DURING DEPLOYMENT. THE NOVAFLEX+ DELIVERY SYSTEM (DS) WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE BALLOON BURST; HOWEVER, IT COULD NOT BE DETERMINED IF THE BURST WAS RADIAL OR LONGITUDINAL BASED ON THE CONDITION OF THE RETURNED DEVICE. THE BALLOON WAS TORN AT THE PROXIMAL CONE. THE GUIDEWIRE LUMEN WAS INTACT; THE NOSE TIP WAS SEPARATED FROM THE GUIDEWIRE LUMEN. NO STRETCHING WAS OBSERVED ON THE GUIDEWIRE LUMEN. STRETCHING WAS NOTED ON THE BALLOON ALONG THE TEAR. THE NOSE TIP AND BALLOON MATERIAL WERE SEPARATED FROM THE DS, BUT NO MANUFACTURING ABNORMALITIES WERE OBSERVED. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE BALLOON WALL THICKNESS. MEASUREMENTS WERE TAKEN CLOSE TO THE BALLOON TEAR ON THE DS AT THE PROXIMAL, DISTAL AND MIDDLE LOCATIONS. THESE MEASUREMENTS MET MANUFACTURING SPECIFICATIONS. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DS. DURING MANUFACTURING, THE DS UNDERGOES MULTIPLE 100% INSPECTIONS AND VERIFICATIONS. THE INSPECTIONS PERFORMED 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 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 ADDITION, THE BALLOON BURST INCREASES THE POSSIBILITY OF AN OBSTACLE (I.E. PATIENT'S ANATOMY OR SHEATH TIP) INTERFERING WITH RETRACTION OF THE BALLOON/BALLOON MATERIAL. THE PHYSICIAN TRAINING MANUAL PROVIDES THE FOLLOWING INSTRUCTION: IF THE INFLATION BALLOON LEAKS OR BURSTS, DO NOT USE EXCESSIVE FORCE WHEN REMOVING THE BALLOON. IN THIS CASE, THE BALLOON BURST AND NOSE TIP SEPARATION WAS CONFIRMED; HOWEVER, NO MANUFACTURING NON-CONFORMITIES WERE IDENTIFIED. DURING THE ENGINEERING EVALUATION THE TYPE OF BALLOON BURST (LONGITUDINAL OR RADIAL) WAS UNABLE TO BE DETERMINED DUE TO THE COMPLETE SEPARATION OF THE INFLATION BALLOON. AVAILABLE INFORMATION SUGGESTS THAT IN THIS CASE, PROTRUDING MATERIAL FROM THE BURST INFLATION BALLOON CAUGHT ON THE DISTAL END OF THE ESHEATH DURING WITHDRAWAL OR ON THE HEMOSTATIC SEALS OF THE SHEATH (IT IS UNCLEAR BY THE REPORTED DESCRIPTION AT WHAT POINT THE SEPARATION OCCURRED). CONSEQUENTLY THE FORCE USED DURING RETRIEVAL OF THE DELIVERY SYSTEM THROUGH THE ESHEATH CAUSED THE NOSE TIP TO SEPARATE FROM THE GUIDEWIRE LUMEN. 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. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2015-00061.

    Description of Event or Problem · 1

    DURING A TRANSFEMORAL TAVR PROCEDURE, THE NOVAFLEX+ (NF+) DELIVERY SYSTEM (DS) BALLOON RUPTURED DURING INFLATION OF A 29MM SAPIEN XT VALVE. DURING VALVE DEPLOYMENT, THE DS BALLOON RUPTURED PRIOR TO COMPLETE VALVE INFLATION, RESULTING IN MILD PARAVALVULAR LEAK (PVL). NO VALVE ROCKING WAS OBSERVED. THE DECISION WAS MADE TO FURTHER ASSESS THE VALVE FOLLOWING PATIENT TRANSFER TO THE FLOOR. WHEN THE DS WAS PULLED BACK, THE DISTAL NOSE TIP WAS NOT VISIBLE. IT WAS DETERMINED THAT THE DISTAL NOSE TIP, PART OF THE BALLOON AND INTERNAL PLASTIC WERE IN THE EXPANDABLE SHEATH (ESHEATH). A SNARE WIRE WAS USED TO SNARE THE DISTAL END OF THE ESHEATH. THE ESHEATH WAS REMOVED, THEN THE DISTAL NOSE TIP, BALLOON AND INTERNAL PLASTIC. FOLLOWING THE ESHEATH REMOVAL, A DISSECTION OF THE ILIAC ARTERY WAS OBSERVED AND REPAIRED. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED IN STABLE CONDITION, HOWEVER, HE LOST APPROXIMATELY 1 LITER OF BLOOD DURING THE PROCEDURE. THE CAUSE OF THE BALLOON RUPTURE IS UNKNOWN. NO SEVERE CALCIFICATION WAS NOTED ON IMAGING TO INDICATE POSSIBLE PROBLEMS DURING THE PROCEDURE. THE PATIENT¿S NATIVE ANNULS MEASURED 20MM BY TEE, WITH A VALVE AREA OF 639.2MM2 AND VALVE PERIMETER OF 91.1MM BY CT. MODERATE ANNULAR CALCIFICATION, MODERATE NATIVE LEAFLET CALCIFICATION AND MILD AORTIC ROOT CALCIFICATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22686 EWDARDS NOVAFLEX+ DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355FS29 59880590

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention