BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROFLEX 3 DELIVERY SYSTEM

    MDR report key: 2951137 · Received February 8, 2013

    Report

    Report Number
    2015691-2013-19239
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE EVENT IS ONGOING.

    Additional Manufacturer Narrative · 1

    AS OF (B)(6) 2013 THE COMPLAINT DEVICE REMAINS UNDER THE CUSTODY OF THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. TO DATE, DESPITE MULTIPLE REQUESTS, THE DEVICE HAS NOT BEEN RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. EDWARDS WILL CONTINUE TO FOLLOW UP FOR RETURN OF THE DEVICE. IF THE DEVICE IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED WITH RESULTS OF THE EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE IS STILL BEING RETAINED BY THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. EDWARDS LIFESCIENCES IS CURRENTLY IN COMMUNICATIONS WITH THE HOSPITAL IN ORDER TO OBTAIN THE DEVICE FOR EVALUATION. IF AND WHEN THE DEVICE IS RETURNED TO EDWARDS, A FOLLOW-UP MDR WILL BE SUBMITTED WITH RESULTS OF THE EVALUATION. PER THE INSTRUCTIONS FOR USE (IFU) OF THE RETROFLEX3 DELIVERY SYSTEM, BALLOON RUPTURE AND SUBSEQUENT BALLOON SEPARATION ARE A POTENTIAL RISK ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE PROCEDURE. THE PHYSICIAN'S TRAINING MANUALS FOR THIS DEVICE RECOMMENDS THAT THE USER NOT USE EXCESSIVE FORCE WHEN REMOVING THE BALLOON IF THE INFLATION BALLOON BURSTS DURING DEPLOYMENT. A DEVICE HISTORY RECORD (DHR) REVIEW PERFORMED REVEALED THAT THE DEVICE MET SPECIFICATIONS PRIOR TO ITS DISTRIBUTION. TRANSCATHETER DELIVERY BALLOON BURST COMPLAINTS HAVE BEEN PREVIOUSLY INVESTIGATED BY EDWARDS AND DOCUMENTED IN A TECHNICAL SUMMARY. 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 IN 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 THIS CASE, PER REPORT, THE PHYSICIAN FELT THAT THE BALLOON RUPTURE WAS CAUSED BY A COMBINATION OF THE PATIENT'S LEAFLET AND ANNULAR CALCIFICATION. ALTHOUGH THE DEVICE HAS NOT YET BEEN RETURNED TO EDWARDS FOR EVALUATION, GIVEN THE REPORT BY THE PHYSICIAN, IN COMBINATION WITH THE REVIEW OF HISTORICAL COMPLAINT DATA, IT CAN BE SPECULATED THAT THE ROOT CAUSE OF THE BALLOON RUPTURE WAS DUE TO THE RATIONALE OUTLINED IN THE ABOVE REFERENCED TECHNICAL SUMMARY. IN ADDITION, A BALLOON BURST INCREASES THE POSSIBILITY OF LEAVING PROTRUDING MATERIAL THAT CAN INTERFERE WITH AN OBSTACLE DURING RETRIEVAL (I.E. PATIENT'S ANATOMY OR SHEATH TIP). THIS MAY EXPLAIN THE REPORTED DIFFICULTIES WITHDRAWING THE DELIVERY SYSTEM THROUGH THE SHEATH. PER THE REPORT, THE RUPTURED BALLOON AND RF3 TIP WERE UNABLE TO FIT INTO THE TIP OF THE SHEATH. THE OPERATORS REALIZED THAT WITH THE BULK OF BALLOON MATERIAL HANGING ON THE END OF THE SHEATH, THEY SHOULD HAVE WITHDRAWN THE DELIVERY SYSTEM AND THE SHEATH TOGETHER. THEY PULLED AGGRESSIVELY WITHOUT KNOWING HOW MUCH PRESSURE TO DELIVER ON THE DELIVERY SYSTEM. IT IS LIKELY THAT THE EXCESSIVE FORCE USED TO PULL THE RUPTURED BALLOON INTO THE SHEATH RESULTED IN THE BALLOON/DISTAL TIP SEPARATION. 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

    ALLEGEDLY REVISED DUE TO MOM COMPLICATIONS.

    Description of Event or Problem · 1

    PER THE REPORT, DURING THE DEPLOYMENT OF THE BIOPROSTHESIS A 1 SECOND COUNT WAS MADE AND THEN THE RETROFLEX3 DELIVERY SYSTEM (RF3) BALLOON RUPTURED. IMMEDIATE ASSESSMENT WAS MADE WITH THE TEE PROBE AND IT WAS DETERMINED BY THE ECHOCARDIOGRAPHER THAT THE VALVE POSITIONING AND RESULT WAS GREAT WITH ZERO PARAVALVULAR LEAK AND NO AORTIC INSUFFICIENCY (AI). WHILE RETRIEVING THE RF3 DELIVERY SYSTEM INTO THE 22 F SHEATH, THE RUPTURED BALLOON AND RF3 TIP WERE UNABLE TO FIT INTO THE TIP OF THE SHEATH. THE PHYSICIAN TEAM, WHILE TRYING TO GET THE DELIVERY SYSTEM INTO THE SHEATH, SHEERED THE YELLOW TIP AND 2/3 OF THE BALLOON MATERIAL OFF OF THE SHAFT OF THE RF3. THE DELIVERY SYSTEM WAS PULLED OUT OF THE BODY. THE TEAM PROCEEDED TO CAPTURE THE YELLOW TIP AND REMAINING BALLOON MATERIAL WITH A SNARE. BOTH SHEATH AND TIP WERE RETRIEVED TOGETHER. THE PATIENT WAS SURGICALLY CLOSED AND REMAINED IN STABLE CONDITION. THE FINAL ANGIO IN THE PELVIS REVEALED A 70% STENOSIS IN THE COMMON ILIAC ARTERY THAT WAS STENTED FROM THE CONTRA LATERAL SIDE. THE PATIENT WAS EXTUBATED IN THE ROOM. ACCORDING TO THE TAVR TEAM ASSESSMENT THE EVENT HAD NO CONSEQUENCE TO THE PATIENT. THE PHYSICIAN TEAM FELT THAT THE BALLOON RUPTURE WAS CAUSED BY A COMBINATION OF THE PATIENT'S LEAFLET AND ANNULAR CALCIFICATION. THEY ALSO REALIZED THAT WITH THE BULK OF BALLOON MATERIAL HANGING ON THE END OF THE SHEATH, THEY SHOULD HAVE PULLED THE DELIVERY SYSTEM AND THE SHEATH TOGETHER TO WITHDRAWAL. THEY PULLED TO AGGRESSIVELY WITHOUT KNOWING HOW MUCH PRESSURE TO DELIVER ON THE RF3 DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53502 RETROFLEX 3 DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS23 59318987

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention