BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 5007522 · Received August 17, 2015

    Report

    Report Number
    2015691-2015-02071
    Event Type
    Injury
    Date Received
    August 17, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: RESULT: KNOWN INHERENT RISK OF PROCEDURE. PER THE INSTRUCTIONS FOR USE (IFU), BALLOON RUPTURE IS A POTENTIAL RISK OF THE TAVR PROCEDURE. THE COMMANDER DELIVERY SYSTEM (DS), WAS RETURNED TO EDWARDS FOR EVALUATION. THE DS WAS RETURNED ADVANCED THROUGH THE ESHEATH, AND THE VALVE WAS CRIMPED ON THE INFLATION BALLOON. PRE-DECONTAMINATION INSPECTION REVEALED A SEVERE KINK ON THE BALLOON SHAFT DISTAL TO THE DOUBLE MARKER BANDS LIKELY DUE TO SHIPPING. SEPARATION AT THE INFLATION TO THE CRIMP BALLOON BOND WAS OBSERVED. VISUAL INSPECTION, PERFORMED AFTER DECONTAMINATION, REVEALED COMPLETE SEPARATION OF THE INFLATION BALLOON FROM THE CRIMP BALLOON PROXIMAL TO THE BOND. THE CRIMP TO INFLATION BALLOON WAS INTACT. DIMENSIONAL ANALYSIS WAS PERFORMED ON THE BALLOON WALL THICKNESS. ALL MEASUREMENTS MET MANUFACTURING SPECIFICATIONS. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. 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 CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES. A DETAILED ROOT CAUSE ANALYSIS REVEALED THAT IT IS VERY UNLIKELY THAT A PRODUCT DEFECT CONTRIBUTED 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 A 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, ALTHOUGH THE BALLOON BURST WAS CONFIRMED, NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION OF THE CRIMP BALLOON REVEALED THAT THE WALL THICKNESS WAS WITHIN SPECIFICATION, AND THE BOND IN THIS LOCATION REMAINED INTACT. AT THIS TIME A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. 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

    DURING THE TRANSFEMORAL TAVR PROCEDURE, DURING THE DEPLOYMENT OF A 26MM SAPIEN 3 (S3) VALVE, THE COMMANDER DELIVERY SYSTEM BALLOON RUPTURED. PERCUTANEOUS ACCESS, UNDER CONSCIOUS SEDATION, WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY (CFA) AND A 14FR EXPANDABLE SHEATH (ESHEATH) WAS PLACED. THE NATIVE AORTIC VALVE WAS CROSSED WITH A FORMED AMPLATZ WIRE, CREATING MODERATE AORTIC INSUFFICIENCY (AI). THE PATIENT BECAME UNSTABLE AND THE WIRE WAS REMOVED FROM THE LEFT VENTRICLE TO ALLOW THE PATIENT TO RECOVER. THE DECISION WAS MADE AT THIS TIME TO FORGO BALLOON AORTIC VALVULOPLASTY (BAV), AND IMPLANT THE VALVE. THE VALVE AND DELIVERY SYSTEM (DS) WERE ADVANCED INTO THE DESCENDING AORTA FOR VALVE ALIGNMENT. ONCE VALVE ALIGNMENT WAS PERFORMED, THE VALVE WAS ADVANCED TO THE AORTIC VALVE FOR DEPLOYMENT. RAPID PACING CAPTURE WAS INITIATED AND INFLATION OF THE BALLOON/VALVE WAS ATTEMPTED WITH NO RESULT. THE BALLOON WOULD NOT INFLATE. RAPID PACING WAS STOPPED AND THE VALVE/DS WERE RETRACTED INTO THE DESCENDING AORTA. AT THIS POINT, THE DELIVERY SYSTEM INFLATION DEVICE HAD BLOOD MIXED WITH SALINE/CONTRAST INDICATING A RUPTURED BALLOON OR A FRACTURED DS. THE S3 VALVE WAS RETRACTED INTO THE ESHEATH AND THE ENTIRE SYSTEM, ESHEATH, VALVE AND DS, WAS REMOVED AS A UNIT. A NEW 26MM S3 VALVE AND DS WERE PREPARED AND THE VALVE WAS SUCCESSFULLY IMPLANTED. FOUR HOURS POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. THE PATIENT'S ANNULUS MEASURED 23MM X 27MM BY CT WITH A VALVE AREA OF 450MM2. MILD ANNULAR CALCIFICATION, MILD NATIVE LEAFLET CALCIFICATION AND MILD AORTIC ROOT CALCIFICATION WERE REPORTED. IT WAS ALSO NOTED THAT THE PATIENT HAD A TORTUOUS AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542127 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS26 60106446

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention