BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3/SAPIEN DELIVERY SYSTEM

    MDR report key: 3110213 · Received May 13, 2013

    Report

    Report Number
    2015691-2013-20068
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE SITE REFUSED TO RELEASE THE DEVICE FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE AFFECTED WORK ORDER DID NOT REVEAL ANY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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. TRANSCATHETER DELIVERY BALLOON BURST COMPLAINTS HAVE BEEN PREVIOUSLY INVESTIGATED BY EDWARDS AND DOCUMENTED IN TECHNICAL SUMMARY (B)(4). 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. DUE TO NO PRODUCT BEING RETURNED FOR EVALUATION, THE REPORTED BALLOON BURST COULD NOT BE CONFIRMED. PER REPORT, IT WAS BELIEVED THAT IMPROPER CRIMPING LEAD TO A WEAKENED BALLOON. HOWEVER, WITHOUT THE RETURNED DEVICE, IT CANNOT BE DETERMINED IF THE BALLOON SUSTAINED ANY DAMAGE DUE TO IMPROPER CRIMPING. THE REPORTED BALLOON/DISTAL TIP SEPARATION ALSO COULD NOT BE CONFIRMED. HOWEVER, A DHR REVIEW AND COMPLAINT HISTORY ANALYSIS DID NOT REVEAL ANY INDICATION THAT A MANUFACTURING NONCONFORMANCE COULD HAVE POTENTIALLY BEEN RELATED TO THE CUSTOMER COMPLAINT. ALTHOUGH IT CANNOT BE CONFIRMED, IT IS POSSIBLE THAT THE IMPROPER CRIMPING OF THE BALLOON THAT WAS DEPLOYED IN THE SETTING OF A CALCIFIED NATIVE ANNULUS CAUSED OR CONTRIBUTED TO THE BALLOON BURST, AND THE TIP MAY HAVE SEPARATED DUE TO THE EFFORT TO WITHDRAWN THE BURST BALLOON THROUGH THE SHEATH. THE COMPLAINT WAS NOT CONFIRMED, AND DUE TO NO DEVICE BEING RETURNED FOR EVALUATION NO MANUFACTURING NONCONFORMITIES COULD BE IDENTIFIED. REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR CONFIRMED COMPLAINTS. THERE IS NO INDICATION OF INCREASING TREND THAT SURPASSES CONTROL LIMITS FOR THIS FAILURE MODE, SO NO FURTHER CORRECTIVE OR PREVENTATIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THIS WAS A TRANSFEMORAL CASE THAT INVOLVED A 10MM CONDUIT TO THE LEFT COMMON ILIAC ARTERY. AFTER DEPLOYMENT OF THE 23MM SAPIEN, IT WAS NOTICED VIA TEE THAT THERE WAS MODERATE CENTRAL AI CAUSED BY A NATIVE LEAFLET OVER HANG WHICH PREVENTED ONE OF THE SAPIEN LEAFLETS TO COAPT PROPERLY. AT THIS POINT A SECOND VALVE WAS PREPPED. DURING THE PREP, THE TECH NOTICED THAT ABOUT 1MM OF THE SAPIEN VALVE WAS CRIMPED ONTO THE PROXIMAL PORTION OF THE NOSE CONE OF THE RF3. IT WAS RECOMMENDED THAT ANOTHER VALVE BE PREPPED. DURING THE CONVERSATION, THEY WERE ABLE TO SLIDE THE VALVE OFF THE NOSE CONE AND DECIDED TO IMPLANT IT. DURING DEPLOYMENT AND BEFORE ALL THE VOLUME WAS INJECTED INTO THE BALLOON, IT RUPTURED. THE VALVE STAYED IN PLACE AND THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE VALVE. VIA TEE, THERE WAS NO CENTRAL OR PARAVALVULAR LEAK AND THE VALVE APPEARED WELL OPPOSED. DURING REMOVAL OF THE DELIVERY SYSTEM, THE NOSE CONE BECAME HUNG UP AT THE END OF THE PROCEDURAL SHEATH. IT WAS DECIDED BY THE PHYSICIANS TO REMOVE THE SYSTEM AS A WHOLE. DURING THAT ATTEMPT, THE NOSE CONE BECAME LODGED IN THE CONDUIT AND SEPARATED FROM THE DELIVERY SYSTEM. THE NOSE CONE WAS THEN RETRIEVED FROM THE CONDUIT. THE PATIENT REMAINED STABLE THROUGHOUT THE CASE. THE CONCLUSION AS TO WHY THE BALLOONED RUPTURED: IT WAS A CIRCUMFERENTIAL RUPTURE AT THE LEVEL OF THE PROXIMAL PORTION OF THE NOSE CONE. THE SAPIEN VALVE BEING CRIMPED ON TOP OF THE NOSE CONE WEAKENED THE BALLOON, CAUSING IT TO FAIL. THE TEAM AGREES WITH THE ASSUMPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210047 RETROFLEX 3/SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23 59356200

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR