BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10252742 · Received July 9, 2020

    Report

    Report Number
    2015691-2020-12453
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 16, 2020
    Report Date
    June 16, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. PROCEDURAL IMAGERY PROVIDED BY THE SITE SHOWED THE PATIENT¿S ACCESS VESSELS APPEARED TORTUOUS, CALCIFIED, AND UNDERSIZED. THE DELIVERY SYSTEM WAS KINKED WHILE ATTEMPTING TO ADVANCE THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS PROTRUDING OUTSIDE OF THE SHEATH LINER. AFTER REMOVAL OF THE SHEATH FROM THE PATIENT, THE SHEATH LINER WAS CONFIRMED TO BE TORN FROM THE STRAIN RELIEF TO THE DISTAL TIP. AFTER REMOVAL OF THE CRIMPED THV FROM THE PATIENT, THE OUTFLOW STRUTS WERE NOTED TO BE DISTORTED. A DEVICE HISTORY RECORDS (DHR) REVIEW DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF THE LOT HISTORY REVEALED NO OTHER SIMILAR COMPLAINTS. THE COMMANDER DELIVERY SYSTEM COMPLAINT HISTORY HAS BEEN REVIEWED AND NO CONFIRMED MANUFACTURING NON-CONFORMANCE WERE IDENTIFIED. THE OCCURRENCE RATE DID NOT EXCEED THE MONTHLY CONTROL LIMITS FOR THE TREND CATEGORY. THE INSTRUCTIONS FOR USE (IFU), DEVICE PREPARATION AND THE TRAINING MANUAL WERE REVIEWED AND NO DEFICIENCIES WERE IDENTIFIED. REGARDING DELIVERY SYSTEM INSERTION THROUGH SHEATH: ORIENT THE DELIVERY SYSTEM WITH THE FLUSH PORT POINTING AWAY AND THE EDWARDS LOGO FACING UP, ENSURE DELIVERY SYSTEM IS LOCKED IN DEFAULT POSITION. INSERTION FORCE THROUGH THE PARTIALLY EXPANDABLE PORTION CAN BE HIGHER THAN THE PUSH FORCE THROUGH THE FULLY EXPANDABLE PORTION. PUSH FORCE CAN VARY DUE TO ANGLE OF INSERTION, THV SIZE, VESSEL DIAMETER, TORTUOSITY AND DEGREE OF CALCIFICATION. IF PUSH FORCE IS HIGH, CONSIDER SLIGHTLY PULLING BACK THE SHEATH WHILE ADVANCING THE THV/DELIVERY SYSTEM 1-2 CM. IN EXPECTATION OF HIGH FRICTION, USE SHORT MOVEMENTS. IF WORKING LENGTH IS INSUFFICIENT, PEEL AWAY THE LOADER TUBE AND REMOVE WHILE MAINTAINING DELIVERY SYSTEM AND WIRE POSITION. IT IS TO BE NOTED, IF PUSH FORCE IS TOO HIGH OR VALVE IS STILL STUCK, REMOVE VALVE AND SHEATH TOGETHER AS A SINGLE UNIT AND REPLACE. DURING THE MANUFACTURING PROCESS, THE DEVICE WAS VISUALLY INSPECTED AND TESTED SEVERAL TIMES. ALL INSPECTIONS ARE CONDUCTED ON 100% OF UNITS, EXCEPT IN THE CASE OF PRODUCT VERIFICATION (PV) TESTING, WHERE THE TESTED UNITS ARE CHOSEN ON A SAMPLING BASIS. ALL TESTED SAMPLE UNITS FOR THIS LOT PASSED PV TESTING. THESE INSPECTIONS AND TESTS DURING THE MANUFACTURING PROCESS SUPPORT THAT IT IS UNLIKELY THAT A NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT EVENT. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. NO EVIDENCE OF PRODUCT NON-CONFORMANCES OR LABELING/IFU INADEQUACIES WERE IDENTIFIED IN THE EVALUATION. THE COMPLAINT FOR DELIVERY SYSTEM VALVE DISLODGED FROM BALLOON WAS CONFIRMED BY THE PROVIDED PROCEDURAL IMAGERY. DUE TO UNAVAILABILITY OF DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS. AS A RESULT, THE PRESENCE OF A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE CONFIRMED. A REVIEW OF MANUFACTURING MITIGATIONS SUPPORTS THAT THE DELIVERY SYSTEM HAS PROPER INSPECTIONS IN PLACE TO DETECT ISSUES RELATED TO THE COMPLAINT EVENTS. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. AS MENTIONED IN THE DESCRIPTION, ¿THE VALVE APPEARED TO GET CAUGHT ON THE OUTSIDE OF THE VESSEL, DUE TO SIGNIFICANT SCAR TISSUE FROM A PATIENT¿S PRIOR ARTERIOTOMY.¿ THE ESHEATH¿S LINER WAS TORN DURING INSERTION OF THE DELIVERY SYSTEM. THE VALVE AND DELIVERY SYSTEM WERE EXPOSED TO THE PATIENT ANATOMY. THE PROVIDED IMAGERY OF THE PATIENT ANATOMY SHOWS TORTUOUS, CALCIFIED, AND UNDERSIZED ACCESS VESSELS BASED ON 3MENSIO MEASUREMENTS. CALCIFIED, TORTUOUS, AND UNDERSIZED VESSELS, IN ADDITION TO EXISTING SCAR TISSUE, CAN CREATE RESTRICTIVE PATHWAYS THAT CAN LEAD TO RESISTANCE DURING DELIVERY SYSTEM ADVANCEMENT AND WITHDRAWAL THROUGH PATIENT ANATOMY. DUE TO THESE EXISTING PATIENT CONDITIONS AND THE SHEATH¿S LINER TEAR, THE VALVE MAY HAVE BEEN CAUGHT ON THE VASCULATURE AND SUBSEQUENTLY DISLODGED DURING RETRIEVAL. THE DISTORTED INFLOW STRUTS OF THE VALVE STRUTS (WHICH WERE PRESENT ON THE DEVICE PRIOR TO REMOVAL FROM THE PATIENT) ARE INDICATIVE OF THE VALVE GETTING CAUGHT ON AN EXTERNAL SURFACE DURING RETRIEVAL. WHILE A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PATIENT (UNDERSIZED ACCESS VESSELS / TORTUOSITY / CALCIFICATION / EXISTING SCAR TISSUE) AND PROCEDURAL (TORN LINER) FACTORS MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. DUE TO THE UNAVAILABILITY OF THE DEVICE, IT CANNOT BE DETERMINED IF A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENTS. 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. SINCE NO PRODUCT NON-CONFORMANCES OR IFU/TRAINING DEFICIENCIES WERE IDENTIFIED DURING THE EVALUATION, NO PRODUCT RISK ASSESSMENT, CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-12451.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-12451.

    Description of Event or Problem · 1

    AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING THE PROCEDURE OF A 23 MM S3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH THE VESSELS WERE PRE-DILATED. THE DELIVERY SYSTEM ORIENTATION APPEARED NORMAL. AS THE DELIVERY SYSTEM WAS INSERTED, ONLY THE NOSE CONE ACTUALLY ENTERED THE CFA. THE VALVE APPEARED TO GET CAUGHT ON THE OUTSIDE OF THE VESSEL, DUE TO SIGNIFICANT SCAR TISSUE FROM A PATIENT¿S PRIOR ARTERIOTOMY. AS FORWARD TENSION WAS APPLIED TO THE DELIVERY SYSTEM, THE E-SHEATH APPEARS TO HAVE RUPTURED ALONG THE SEAM, EXPOSING THE VALVE AND DELIVERY SYSTEM TO THE SURROUNDING TISSUE. NO INJURY TO THE VESSEL WAS REPORTED. THE DELIVERY SYSTEM WENT FORWARD BUT THE NOSE CONE FLIPPED BACKWARDS. THE RESISTANCE CAUSED A LINER TEAR. THERE WAS NO STEEP ANGLE. WHILE ATTEMPTING TO REMOVE THE VALVE, DELIVERY SYSTEM AND E-SHEATH AS ONE UNIT; THE VALVE SLIPPED OFF OF THE DELIVERY SYSTEM AND REMAINED IN THE BODY. THE VALVE REMAINED IN THE TISSUE NEAR THE FEMORAL HEAD VASCULAR ACCESS SITE. THE ESHEATH AND DS WERE REMOVED TOGETHER AS A UNIT. A SMALL PORTION OF THE VALVE OUTFLOW WAS EXPOSED EXTERNALLY. A SMALL INCISION WAS MADE AND THE VALVE WAS REMOVED USING A HEMOSTAT. ANOTHER 23 MM S3 VALVE WAS PREPPED AND IMPLANTED. UPON REMOVAL OF THE VALVE, FRAME DAMAGE WAS OBSERVED. ONE OF THE STRUTS ON THE INFLOW WAS ANGLED 90 DEGREES FROM ITS ORIGINAL POSITION. THE DAMAGE TO THE VALVE FRAME OCCURRED WHILE STILL IN THE PATIENT PRIOR TO REMOVAL. PER MEDICAL OPINION. THE PHYSICIAN BELIEVES THE INITIAL RESISTANCE WAS DUE TO SIGNIFICANT SCAR TISSUE PATIENT FACTORS. PATIENT IS DOING WELL. THE PATIENT WAS NOTED TO HAVE SIGNIFICANT CALCIUM AND TORTUOSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716913 COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM23A 63053350

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention