BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10938819 · Received December 3, 2020

    Report

    Report Number
    2015691-2020-14818
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    November 6, 2020
    Report Date
    November 6, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. REVIEW OF PROCEDURAL IMAGERY PROVIDED BY THE SITE FOUND A PERIPHERAL STENT WAS ON THE VALVE AT THE AORTIC ANNULUS. NO DAMAGE WAS NOTED ON THE FULLY DEPLOYED VALVE. THE VALVE WAS EXPLANTED WITH OUTFLOW FRAME DAMAGE SURROUNDED BY HOST TISSUE. THE EXPLANTED PERIPHERAL STENT WAS ALSO SHOWN TO BE SURROUNDED BY HOST TISSUE. AS THE LOT NUMBER WAS NOT PROVIDED A DEVICE HISTORY RECORD AND LOT HISTORY WERE UNABLE TO BE PERFORMED. THE INSTRUCTIONS FOR USE (IFU) DEVICE PREPARATION AND THE TRAINING MANUAL WERE REVIEWED FOR INSTRUCTIONS OR GUIDANCE FOR PROPER USE OF THE DEVICE AND NO DEFICIENCIES WERE IDENTIFIED. DURING THE MANUFACTURING PROCESS THE COMMANDER DELIVERY SYSTEM IS VISUALLY INSPECTED AND TESTED SEVERAL TIMES. DURING MANUFACTURING THE COMMANDER WAS 100% INSPECTED. DURING FINAL INSPECTION, THE COMMANDER UNDERWENT 100% INSPECTION BY BOTH MANUFACTURING AND QUALITY. ADDITIONALLY, ALL MANUFACTURING LOTS ARE SUBJECT TO PRODUCT VERIFICATION (PV) TESTING ON A SAMPLING BASIS. ALL SAMPLES PASSED PROCESS SUPPORT THAT IT IS UNLIKELY THAT A NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE.  THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE COMPLAINTS FOR THE DELIVERY SYSTEM DIFFICULTY CROSSING NATIVE ANNULUS WAS CONFIRMED BY EVALUATION OF THE PROVIDED PROCEDURAL IMAGERY. DUE TO UNAVAILABILITY OF THE DEVICE, ENGINEERING WAS UNABLE TO BE PERFORM ANY VISUAL, FUNCTIONAL, OR DIMENSIONAL ANALYSIS. ADDITIONALLY, AS THE LOT NUMBER OF THE ALLEGED DEVICE WAS NOT PROVIDED, DHR AND LOT HISTORY REVIEWS WERE NOT ABLE TO BE PERFORMED. THEREFORE, A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. HOWEVER, REVIEWS OF COMPLAINT HISTORY AND MANUFACTURING MITIGATIONS REVEALED NO INDICATION THAT A MANUFACTURING NONCONFORMANCE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. ACCORDING TO THE COMPLAINT DESCRIPTION, ¿ON INSERTION OF THE COMMANDER DELIVERY SYSTEM, UNBEKNOWNST TO THE TEAM, THE PERIPHERAL STENTS WERE CARRIED UP TO THE AORTIC ROOT. THE PERIPHERAL STENT(S) WERE BEING DRAGGED ACROSS THE AORTIC ROOT.¿ AS PROCEDURAL VIDEOS SHOW, THE PERIPHERAL STENT WAS STUCK ON THE VALVE BEFORE AND AFTER DEPLOYMENT. THE PERIPHERAL STENT LIKELY MADE CONTACT WITH THE NATIVE ANNULUS DURING VALVE CROSSING, LEADING TO THE EXPERIENCED DIFFICULTY AND SUBSEQUENT AORTIC ROOT DISSECTION. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (THV INTERACTION WITH DISLODGED PERIPHERAL STENT ACROSS AORTIC ROOT) CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED. NO MANUFACTURING RELATED NONCONFORMANCES WERE IDENTIFIED. 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 LABELING/IFU/TRAINING INADEQUACIES HAVE BEEN IDENTIFIED. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT ESCALATION, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    AS REPORTED BY A FIELD CLINICAL SPECIALIST, DURING THE PROCEDURE OF A 26 MM SAPIEN 3 ULTRA VALVE IN THE AORTIC POSITION VIA TRANSFEMORAL APPROACH BEFORE INSERTING THE 14 FR ESHEATH, THE PHYSICIANS DID A PERIPHERAL ANGIOPLASTY OF THE CALCIFIED LEFT COMMON ILIAC AND DISTAL AORTA WITH A SHOCKWAVE BALLOON. THERE WERE 'KISSING STENTS' FROM THE RIGHT AND LEFT COMMON ILIAC EXTENDING INTO THE DISTAL AORTA. THERE WAS DIFFICULTY CROSSING THE AORTIC ANNULUS WITH THE DELIVERY SYSTEM, WHICH WAS THOUGHT TO BE DUE TO HEAVY LEAFLET CALCIUM. THE PATIENT BECAME HYPOTENSIVE AND THE VALVE WAS DEPLOYED.  FINAL ANGIOGRAPHY INDICATED A DISSECTION OF THE AORTIC ROOT AND ASCENDING AORTA DUE TO THE PERIPHERAL STENTS WHICH HAD BEEN INADVERTENTLY CARRIED UP TO THE AORTIC ROOT. THE PATIENT WAS PUT ON FEMORAL BYPASS AND A STERNOTOMY WAS PERFORMED. DURING SURGERY IT WAS FOUND THAT THERE WAS A TEAR IN THE ¿RIGHT-NON COMMISSURE¿ OF THE AORTIC ROOT AS WELL AS AN ASCENDING AORTIC DISSECTION. THE SAPIEN 3 ULTRA VALVE WAS EXPLANTED FOR AORTIC ROOT REPAIR AND AN EDWARDS PERIMOUNT SURGICAL VALVE WAS IMPLANTED. THE PATIENT WAS MOVED FROM FEMORAL BYPASS TO ECMO AND PER THE LATEST REPORT WAS IN STABLE CONDITION. AFTER THE CASE, THE PRE-TAVR CT RECONSTRUCTION AND INTRA-PROCEDURAL IMAGES WERE REVIEWED AGAIN AND THE 'KISSING STENTS' WERE BARELY VISIBLE.  IT IS BELIEVED THAT ONE OR BOTH PERIPHERAL STENTS WERE LIKELY CARRIED UP TO THE TIP OF SHEATH. THEN ON INSERTION OF THE COMMANDER DELIVERY SYSTEM, THE PERIPHERAL STENT(S) WERE BEING DRAGGED ACROSS THE AORTIC ROOT, WHICH IN RETROSPECT MAY HAVE BEEN THE REAL CAUSE OF THE DIFFICULTIES CROSSING THE NATIVE ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403302 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM26A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention