BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENDRA + DELIVERY SYSTEM

    MDR report key: 3942625 · Received July 17, 2014

    Report

    Report Number
    2015691-2014-01619
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: RESULTS: OTHER: CONCLUSION: OTHER. THE DELIVERY SYSTEM, LOADER, SHEATH, AND VALVE WERE RETURNED TO EDWARDS FOR EVALUATION IN A USED CONDITION. THE VALVE WAS CRIMPED ONTO THE BALLOON/DELIVERY SYSTEM, AND PULLED BACK INTO THE HOUSING OF THE SHEATH. SEVERAL KINKS WERE OBSERVED ON THE DELIVERY SYSTEM BALLOON SHAFT, PROXIMAL TO WHERE THE SHEATH HOUSING WAS LOCATED UPON THE CONDITION OF RETURN. THIS IS SUSPECTED TO HAVE OCCURRED DURING DIFFICULT ATTEMPTS AT CROSSING THE HIGHLY CALCIFIED NATIVE VALVE. A FULL EVALUATION OF THE DEVICE COULD NOT BE COMPLETED AS THE CRIMPED VALVE WAS PULLED BACK INTO THE SHEATH HOUSING; HOWEVER, NO ABNORMALITIES WERE DETECTED DURING VISUAL INSPECTION OF THE REST OF THE DEVICE. NO OTHER RELEVANT TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. PER THE INSTRUCTIONS FOR USE (IFU) CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. ACCESS SITE INJURIES, INCLUDING DISSECTION OF THE AORTIC WALL DURING THE TRANSAORTIC APPROACH, ARE A RECOGNIZED COMPLICATION OF THE TAVR PROCEDURE IN THIS ELDERLY POPULATION WITH MULTIPLE CO-MORBIDITIES. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE THV TRAINING MANUALS INSTRUCT THE USER TO DETERMINE WITH CT IF THE PLANNED AORTIC ACCESS SITE IS FREE OF CALCIFICATION, ALLOWS THE SHEATH TO BE PLACED IN A STRAIGHT LINE, AND LEAVES ADEQUATE ROOM BETWEEN THE TIP OF THE SHEATH AND NATIVE AORTIC VALVE ANNULUS TO ALLOW FULL BALLOON EXPANSION. CONSIDERATIONS FOR APPROACH (PARTIAL J-STERNOTOMY OR RIGHT MINI-THORACOTOMY), ACCESS AND STABILIZATION OF THE SITE ARE ALSO PROVIDED IN THE TRAINING. IN THIS CASE, PER REPORT, THE AORTIC DISSECTION WAS A PROCEDURAL COMPLICATION CAUSED BY THE VALVE/DELIVERY SYSTEM AS IT WAS WITHDRAWN THROUGH THE PATIENT¿S AORTA AFTER UNSUCCESSFUL ATTEMPTS TO CROSS THE NATIVE VALVE. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS AGAIN RECEIVED THAT CLARIFIED THAT THE INJURY WAS ASSOCIATED WITH THE ASCENDRA + DELIVERY SYSTEM AND NOT THE BAV BALLOON. AS SUCH, THIS EVENT IS ONCE AGAIN CONSIDERED REPORTABLE AND A CORRECTED SUPPLEMENTAL REPORT IS BEING SUBMITTED. DIFFICULTY WAS ENCOUNTERED IN ATTEMPTS TO CROSS THE NATIVE VALVE WITH THE DELIVERY SYSTEM. AFTER MANY UNSUCCESSFUL ATTEMPTS THEY HAD TO PULL OUT THE WHOLE SYSTEM. AS THE DELIVERY SYSTEM WITH CRIMPED VALVE WAS WITHDRAWN, IT CAUSED A LOCAL DAMAGE OF THE AORTA AT THE PUNCTURE POINT. THE COMPLICATION WAS TREATED SUCCESSFULLY BY A SURGEON WITH PATCHES. INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION STATED THAT THE INJURY ORIGINALLY REPORTED ON THE ASCENDRA+ DELIVERY SYSTEM WAS RELATED TO A BAV BALLOON RUPTURE. THE NEW INFORMATION IS UNDERGOING INVESTIGATION. AS SUCH, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND A CORRECTED SUPPLEMENTAL REPORT IS BEING SUBMITTED. REFERENCE MFGR REPORT #2015691-2014-01966.

    Description of Event or Problem · 1

    AS REPORTED BY EDWARDS EUROPEAN AFFILIATE, DURING THE TRANSAORTIC TAVR PROCEDURE, THERE WAS DIFFICULTY CROSSING THE SEVERELY CALCIFIED NATIVE ANNULUS, WHICH CAUSED AN AORTIC DISSECTION. INITIALLY DURING BAV WITH THE BALLOON POSITIONED APPROPRIATELY AND WITH PROPER VOLUME, THE BALLOON RUPTURED AFTER INFLATION. THE BALLOON RUPTURE WAS MOST PROBABLY DUE TO MASSIVE CALCIFICATION OF THE AORTIC ANNULUS AND LEAFLETS. THE CALCIFICATION WAS PRIMARILY VISIBLE ON ECHO, HOWEVER, IT SEEMED MUCH LESS SEVERE THAN TURNED OUT TO BE. AFTER VALVULOPLASTY, THE OPERATOR DECIDED TO IMPLANT THE SAPIEN XT VALVE. HOWEVER, AFTER CROSSING THROUGH THE SHEATH, IT WAS NOT POSSIBLE TO PUSH THE SYSTEM ANY FURTHER. THIS WAS PROBABLY THE RESULT OF THE SEVERE CALCIFICATION WHICH DID NOT ALLOW THE SYSTEM TO CROSS. AT THE SAME TIME IT CAUSED AN AORTIC DISSECTION. AFTER PULLING OUT THE SYSTEM, THE OPERATOR STABILIZED THE PATIENT AND FORTUNATELY THE CASE ENDED WITH NO CPR, NO SERIOUS HEMODYNAMIC INSTABILITY AND THE PATIENT SEEMED TO RECOVER. NO PIECES OF THE BALLOON REMAINED IN THE PATIENT AND THE REASON FOR THE BURST WAS PROBABLY CALCIFICATION. NO VALVE WAS IMPLANTED. THE PATIENT WAS POSTPONED FOR TA APPROACH. THERE WERE NO ISSUES NOTED WITH THE DELIVERY SYSTEM OR VALVE DURING PREP/PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418353 ASCENDRA + DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9355AS26 59656450

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other| R