BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EDWARDS DELIVERY SYSTEM

    MDR report key: 9851055 · Received March 18, 2020

    Report

    Report Number
    2015691-2020-11019
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    January 31, 2019
    Report Date
    February 24, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE STATUS OF THE DELIVERY SYSTEM REMAINS UNKNOWN. NO APPLICABLE IMAGERY WAS PROVIDED FOR REVIEW. THE DEVICE HISTORY RECORD (DHR) AND LOT HISTORY REVIEW WERE UNABLE TO BE PERFORMED AS NO WORK ORDER WAS PROVIDED. AS THE COMPLAINT WAS UNABLE TO BE CONFIRMED AND THE CONTROL LIMITS FOR THE ASSOCIATED TREND CATEGORY (LEAKAGE) WAS NOT EXCEEDED FOR (B)(6) 2020, A COMPLAINT HISTORY REVIEW IS NOT REQUIRED. THE LATEST REVISIONS IN ACCORDANCE TO THE OCCURRENCE DATE OF THE EVENT WERE REVIEWED SINCE NO LOT NUMBER WAS PROVIDED FOR THE DELIVERY SYSTEM AS THEY ARE THE MOST RELEVANT AND REPRESENTATIVE OF MANUFACTURING STEPS. DURING THE MANUFACTURING PROCESS, THE ENTIRE DELIVERY SYSTEM IS VISUALLY INSPECTED AND TESTED SEVERAL TIMES. THESE INSPECTIONS SUPPORT THAT IT IS UNLIKELY THAT A DEFECT PRESENT IN MANUFACTURING CONTRIBUTED TO THE COMPLAINTS. AS IT IS UNKNOWN WHICH EDWARDS DELIVERY SYSTEM WAS USED FOR THIS PROCEDURE, THIS EVALUATION WAS CONDUCTED FOR THE COMMANDER DELIVERY SYSTEM, AS ALMOST ALL OF THE DELIVERY SYSTEMS USED IN THE ARTICLE WERE COMMANDER. IT SHOULD BE NOTED THAT THE SAPIEN 3 THV WAS DEPLOYED USING A NON-EDWARDS SHEATH IN THE PULMONIC POSITION. THE SAPIEN 3 WITH THE COMMANDER DELIVERY SYSTEM (DS) IS CURRENTLY INDICATED FOR NATIVE AORTIC VALVE REPLACEMENT AND SURGICAL BIOPROSTHETIC AORTIC OR MITRAL VALVE REPLACEMENT. THE INSTRUCTIONS FOR USE (IFU) AND TRAINING MANUALS IN THIS SECTION ARE FOR A TF PROCEDURE IN THE AORTIC POSITION FOR RELEVANT GUIDANCE FOR AN S3 IMPLANT USING THE COMMANDER DS. THE LATEST REVISIONS IN ACCORDANCE TO THE OCCURRENCE DATE OF THE EVENT WERE REVIEWED SINCE NO LOT NUMBER WAS PROVIDED FOR THE DELIVERY SYSTEM AS THEY ARE THE MOST RELEVANT AND REPRESENTATIVE OF PROCEDURAL STEPS. THE DELIVERY SYSTEM IFU, PREPPING MANUAL, AND DEVICE TRAINING MANUAL WERE REVIEWED FOR INSTRUCTIONS INVOLVING DEVICE PREPARATION AND PROCEDURES RELATING TO THE COMPLAINT EVENT. AS THERE ARE NO SPECIFIC IFU OR TRAINING MATERIALS RELATED TO SAPIEN 3 WITH PULMONIC PROCEDURES, THE AVAILABLE TRAINING MATERIALS WERE REVIEWED ONLY FOR INFORMATION POTENTIALLY RELEVANT TO THE DEVICE USE. THE PROCEDURAL TRAINING MANUAL PROVIDES GUIDANCE ON DELIVERY SYSTEM BALLOON RUPTURES OR LEAKS DURING DEPLOYMENT WITHOUT THV EMBOLIZATION. FACTORS THAT MAY ASSIST IN BALLOON RUPTURES OR LEAKS ARE AS FOLLOWS: DO NOT USE EXCESSIVE FORCE, TAKE CARE WHEN CROSSING THE THV, TRACKING BACK OVER THE ARCH AND REMOVING THE DELIVERY SYSTEM (THROUGH THE TIP OF THE SHEATH), MAINTAIN GUIDEWIRE POSITION, CHECK FOR PV LEAKS UNDER ECHO AND IF POST-DILATION NEEDED, USE A NEW DELIVERY SYSTEM. BASED ON THE REVIEW OF THE IFU/TRAINING MANUALS, NO DEFICIENCIES WERE IDENTIFIED. THE COMPLAINT FOR BALLOON LEAKAGE 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 MATERIAL REVEALED NO DEFICIENCIES. AS NO PATIENT OR PROCEDURAL IMAGERY WAS PROVIDED, A DEFINITE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS POINT. HOWEVER, IT IS POSSIBLE THAT: EXCESSIVE MANIPULATION OF THE DEVICE DURING THE DELIVERY SYSTEM INSERTION/ADVANCEMENT OR VALVE ALIGNMENT AS A RESULT OF VESSEL TORTUOSITY MAY RESULT IN DAMAGE TO THE BALLOON OR BALLOON CATHETER BONDS. CALCIFICATION IN THE PATIENT ANATOMY CAN ALSO CAUSE DAMAGE TO THE INFLATION BALLOON AND/OR CRIMP BALLOON. PERFORMING VALVE ALIGNMENT IN A NON-STRAIGHT SECTION OF THE VASCULATURE CAN CAUSE THE THV TO UNSEAT (NON-COAXIAL PLACEMENT OF THE THV IN RELATION TO THE FLEX TIP) FROM THE FLEX TIP AND ¿DIVE¿ INTO THE LUMEN OF THE FLEX TIP. IF THE THV IS UNSEATED DURING VALVE ALIGNMENT, IT CAN RESULT IN HIGHER THAN USUAL ALIGNMENT FORCES, WEAKENING THE BALLOON MATERIAL NEAR THE INFLATION TO CRIMP BALLOON BOND. SUBSEQUENTLY, THE BALLOON MAY BE MORE PRONE TO TEARING OR LEAKAGE. UNDER SIMULATED CONDITIONS (TORTUOUS ANATOMY), A PREVIOUSLY PERFORMED ENGINEERING STUDY WAS ABLE TO RECREATE HIGH VALVE ALIGNMENT FORCES WITH VALVE DIVING. RESIDUAL VOLUME LEFT IN THE BALLOON MAY ALSO CONTRIBUTE TO INCREASED FORCES DURING VALVE ALIGNMENT, WHICH COULD LEAD TO A WEAKENING OF THE BALLOON MATERIAL. ANOTHER PREVIOUSLY PERFORMED ENGINEERING STUDY WAS ABLE TO RECREATE HIGH ENOUGH VALVE ALIGNMENT FORCES TO POTENTIALLY CAUSE A MATERIAL FAILURE IN THE AREA IN QUESTION. IMPROPER TECHNIQUE WHEN REMOVING THE PROXIMAL BALLOON COVER CAN CAUSE DAMAGES TO THE BALLOON, MAKING IT MORE SUSCEPTIBLE TO LEAKAGE AFTER INSERTION. ADDITIONALLY, THE COMMANDER DELIVERY SYSTEM WAS USED IN THE PULMONIC POSITION THAT IS NOT THE DELIVERY SYSTEM¿S INTENDED USE, WHICH COULD LEAD TO ADVERSE EFFECTS. WHILE A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (OFF LABEL USE) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. 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. SINCE NO EDWARDS DEFECT, WHICH COULD HAVE RESULTED IN THE COMPLAINT, WAS CONFIRMED, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED. SINCE NO PRODUCT NON-CONFORMANCES OR IFU/TRAINING DEFICIENCIES WERE IDENTIFIED DURING EVALUATION, A PRODUCT RISK ASSESSMENT ESCALATION IS NOT REQUIRED. THE COMPLAINT FOR WAS UNABLE TO BE CONFIRMED. NO LABELING INADEQUACIES AND NO MANUFACTURING NONCONFORMANCE WERE IDENTIFIED DURING EVALUATION. A DEFINITE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME, BUT IT IS POSSIBLE THAT PROCEDURAL FACTORS (OFF LABEL USE) CONTRIBUTED TO THE REPORTED EVENT. SINCE NO MANUFACTURING NON-CONFORMANCES, LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED, AND THE OCCURRENCE RATE DID NOT EXCEED THE TRENDING CONTROL LIMITS; THEREFORE, NO CORRECTIVE AND PREVENTATIVE ACTION NOR PRA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. IN THIS CASE, THE EXACT DELIVERY SYSTEM MODEL NUMBER IS NOT AVAILABLE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS DELIVERY SYSTEM ARE LISTED BELOW: P110021- RETROFLEX 3 DELIVERY SYSTEM; P130009 ¿ NOVAFLEX+ DELIVERY SYSTEM; P140031- EDWARDS COMMANDER DELIVERY SYSTEM.   ARTICLE REFERENCE: KENNY D, MORGAN GJ, MURPHY M, ALALWI K, GIUGNO L, ZABLAH J, CARMINATI M, WALSH K. USE OF 65 CM LARGE CALIBER DRYSEAL SHEATHS TO FACILITATE DELIVERY OF THE EDWARDS SAPIEN VALVE TO DYSFUNCTIONAL RIGHT VENTRICULAR OUTFLOW TRACTS. CATHETER CARDIOVASC INTERV. 2019 SEP 1;94(3):409-413. DOI: 10.1002/CCD.28409. EPUB 2019 AUG 13. PUBMED PMID: 31408262.

    Description of Event or Problem · 1

    THROUGH THE REVIEW OF THE MEDICAL ARTICLE: "USE OF 65 CM LARGE CALIBER DRYSEAL SHEATHS TO FACILITATE DELIVERY OF THE EDWARDS SAPIEN VALVE TO DYSFUNCTIONAL RIGHT VENTRICULAR OUTFLOW TRACTS". CORRESPONDING AUTHOR KEVIN WALSH, THE FOLLOWING EVENTS WERE IDENTIFIED: RETROSPECTIVE ANALYSIS OF ALL PATIENTS FROM THREE LARGE CONGENITAL HEART CENTERS UNDERGOING TRANSCATHETER PULMONARY VALVE REPLACEMENT (TPVR) WITH THE EDWARDS SAPIEN VALVE (SAPIEN XT AND S3 VALVES) DELIVERED WITH THE 65 CM GORE DRYSEAL SHEATH. ONE PATIENT REQUIRED A SECOND VALVE DUE TO RESIDUAL SUBVALVAR RVOT STENOSIS. THIS PATIENT ULTIMATELY REQUIRED SURGERY FOR RESIDUAL RVOT GRADIENT SECONDARY TO A COMPLEX RVOT MEMBRANE. IN ONE PATIENT, WE ATTEMPTED TO LOAD A 29 MM VALVE ONTO THE BALLOON, AS PER THE STANDARD LOADING APPROACH, WITHIN THE DRYSEAL SHEATH. ON VALVE DEPLOYMENT, THE BALLOON DID NOT FULLY INFLATE AND ALTHOUGH WE MANAGED TO DEPLOY THE VALVE SAFELY, THE BALLOON CONTAINED A PINHOLE PUNCTURE. IT IS UNCLEAR IF THE LOADING PROCESS WITHIN THE DRYSEAL PRECIPITATED THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314603 UNKNOWN EDWARDS DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TF DELIVERY SYSTEM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1