BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS CERTITUDE DELIVERY SYSTEM

    MDR report key: 8010263 · Received October 26, 2018

    Report

    Report Number
    2015691-2018-04402
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    October 4, 2018
    Report Date
    October 5, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION INDICATED THE ANNULUS DIAMETER WAS 22.4X20.6 WITH SEVERE CALCIFICATION. THE BALLOON BURST AT THE END OF VALVE DEPLOYMENT. CALCIFICATION IS THOUGHT TO BE THE REASON FOR THE BALLOON BURST. THE CERTITUDE WAS REMOVED AS USUAL FOR TA. THE DELIVERY SYSTEM (DS) WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION AFTER BEING USED IN THE PROCEDURE. THE DS WAS RETURNED WITH NOSE TIP AND GUIDEWIRE LUMEN SEPARATED AND INSERTED THROUGH THE SHEATH. PHOTOGRAPHS FROM THE COMPLAINT SITE WERE PROVIDED FOR FURTHER EVALUATION. THE NOSE TIP AND GUIDEWIRE LUMEN WERE SEPARATED FROM THE DELIVERY SYSTEM. THE PORTION OF THE BALLOON ATTACHED TO THE NOSE TIP APPEARED BUNCHED. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE GUIDEWIRE LUMEN AND NOSE TIP ARE SEPARATED FROM THE REST OF THE DELIVERY SYSTEM AND INSERTED THROUGH SHEATH. RADIAL AND LONGITUDINAL BURST WAS CONFIRMED, AND DOES NOT APPEAR TO BE MISSING ANY BALLOON PIECES. THE DISTAL BALLOON SHOULDER WAS FLARED. ADHESIVE WAS OBSERVED ON GW LUMEN AT Y-CONNECTOR. THE SHEATH HAD A KINK APPROXIMATELY 3" DISTAL TO HOUSING, MINOR DELAMINATION AT MULTIPLE POINTS AT TIP (NOT CIRCUMFERENTIAL). NO FUNCTIONAL TESTING WAS ABLE TO BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE (BALLOON BURST AND GUIDEWIRE SEPARATED). BALLOON SINGLE WALL THICKNESS MEASUREMENTS WERE TAKEN WITH A DIGITAL BLADE MICROMETER. WALL THICKNESS BEING OUT OF SPECIFICATION COULD CONTRIBUTE TO THE COMPLAINT EVENT. THE SINGLE WALL SPECIFICATION WAS CALCULATED TO MEET THE SPECIFICATION. EDWARDS CERTITUDE DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), AND COMMANDER PROCEDURAL TRAINING MANUAL WERE REVIEWED. NO IFU/TRAINING MANUAL DEFICIENCIES WERE IDENTIFIED. DURING BALLOON MANUFACTURING, THE BALLOON WAS 100% VISUALLY INSPECTED FOR FISH EYES, CROW¿S FEET, AND CONTAMINATION. THE BALLOON WORKING LENGTH, DIAMETER, PROXIMAL AND DISTAL LEG IDS, PROXIMAL LEG OD, AND DOUBLE WALL THICKNESS WERE ALSO 100% INSPECTED. DURING MANUFACTURING OF THE DELIVERY SYSTEM, THE BALLOONS ARE 100% INSPECTED FOR CONTAMINATION PRIOR TO PLEAT AND FOLDING. AFTER COMPLETION OF PLEAT AND FOLDING, THE BALLOON IS INSPECTED WITH A GO/NO-GO GAGE AND IS VISUALLY INSPECTED FOR CONTAMINATION, TEARS, DISTORTED/PINCHED FOLDS, AND WRINKLES. THE DEVICES ALSO UNDERGO 100% FINAL INSPECTION BY MANUFACTURING AND QUALITY. IT IS VISUALLY INSPECT BALLOON USING MINIMUM 8X MAGNIFICATION FOR SCRATCHES, TEARS, WRINKLES, AND EXCESSIVE ADHESIVE ON OR WITHIN BALLOON. THE ENTIRE DELIVERY SYSTEM IS INSPECTED FOR MECHANICAL DAMAGE (I.E. KINKS, BREAKS, SEPARATION), MISPLACED/MISSING/EXTRA/INCORRECTLY ASSEMBLED PARTS, AND CONTAMINATION. BALLOON BURST TESTING WAS PERFORMED ON THE FINISHED WORK ORDER UNDER A SAMPLING BASIS DURING PRODUCT VERIFICATION TESTING. ALL SAMPLES TESTED UNDER THE RELATED WORK ORDER MET STATISTICAL ACCEPTANCE CRITERIA. THESE INSPECTIONS SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NONCONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINTS. DURING MANUFACTURING, THE DELIVERY SYSTEM IS 100% VISUALLY INSPECTED BY MANUFACTURING AND QUALITY. THE ENTIRE DELIVERY SYSTEM IS INSPECTED FOR MECHANICAL DAMAGE ( I.E. KINKS, BREAKS, OR SEPARATION). PRODUCT VERIFICATION (PV) TESTING WAS DONE ON FINISHED PRODUCTS AND ALL SAMPLES TESTED UNDER THE RELATED WORK ORDER MET STATISTICAL ACCEPTANCE CRITERIA. THESE INSPECTIONS SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NONCONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINTS. THE COMPLAINTS FOR ¿BALLOON- BURST¿, ¿DELIVERY SYSTEM- WITHDRAWAL DIFFICULTY-THROUGH SHEATH¿ AND ¿DISTAL TIP, NOSE TIP- SEPARATED¿ WERE CONFIRMED, AND NO MANUFACTURING NON-CONFORMITIES WERE FOUND IN THE RETURNED SAMPLE. REVIEW OF MANUFACTURING MITIGATIONS REVEALED NO INDICATION THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINTS. A REVIEW OF THE IFU AND TRAINING MATERIALS REVEALED NO DEFICIENCIES. IT WAS NOTED THAT SEVERE VALVE CALCIFICATION WAS PRESENT. THIS FURTHER INDICATES THAT THE BALLOON MAY HAVE COME INTO CONTACT WITH THE CALCIUM, RESULTING IN THE BURST. BASED ON THIS ACCOUNT AND A REVIEW OF COMPLAINT HISTORY, IT IS LIKELY THAT THE ROOT CAUSE OF THE BALLOON BURST IS RELATED TO THOSE DETAILED IN A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES. A DETAILED ROOT CAUSE ANALYSIS FOR SIMILAR RETURNED COMPLAINTS HAS BEEN SUMMARIZED IN THE TECHNICAL SUMMARY. THE TECHNICAL SUMMARY PROVIDES A RATIONALE AS TO WHY IT IS UNLIKELY THAT A PRODUCT DEFECT OR MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THIS TYPE OF EVENT, AND IT DETAILS WHY BALLOONS ARE SUBJECT TO INCREASED RISK OF BURST IN A CALCIFIED ANNULUS (CALCIFIED NODULES WITHIN THE ANNULUS CAN IMPINGE ON THE BALLOON DURING INFLATION, THUS COMPROMISING THE BALLOON WALL STRUCTURE EVEN AT A LOW INFLATION PRESSURE). THE TECHNICAL SUMMARY ALSO OUTLINES THE EXTENSIVE MANUFACTURING MITIGATIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, LEAK TESTING, AND FUNCTIONAL BALLOON BURST TESTING THAT OCCURS WITH EVERY MANUFACTURED LOT). ANALYSES OF THESE TYPES OF RUPTURES INDICATE THAT THEY ARE TYPICALLY CAUSED BY INTERACTION WITH CALCIFICATION IN THE ANNULUS. THE TECHNICAL SUMMARY CONTAINS ADDITIONAL DETAILS RELATED TO ROOT CAUSE ANALYSIS ON BALLOON BURSTS IN A CALCIFIED ANNULUS. ADDITIONALLY BECAUSE THE BALLOON BURST, IT IS LIKELY THE TORN BALLOON GOT CAUGHT ON THE DISTAL TIP OF THE SHEATH DURING WITHDRAWAL, AND EXCESSIVE OR FORCEFUL MANIPULATION OF THE DEVICE CAUSED THE NOSE TIP TO BECOME SEPARATED. AS STATED, ¿DURING RETRIEVAL, DIFFICULTIES WERE ENCOUNTERED TO GET THE BALLOON BACK INTO THE SHEATH AND THE DISTAL TIP OF THE CERTITUDE DELIVERY SYSTEM WAS SEPARATED SPONTANEOUSLY¿. IN EVENT OF A BALLOON BURST, EXCESSIVE FORCE SHOULD NOT BE USED TO WITHDRAW THE DELIVERY SYSTEM THROUGH THE SHEATH TIP. AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENTS. AVAILABLE INFORMATION THEREFORE SUGGESTS THAT PATIENT FACTORS (CALCIFICATION) AND/OR PROCEDURAL FACTORS (EXCESSIVE FORCE USED DURING WITHDRAWAL) LIKELY CONTRIBUTED TO THE COMPLAINT EVENTS. NO VISUAL ABNORMALITIES WERE OBSERVED ON THE RETURNED SAMPLE, DIMENSIONAL MEASUREMENTS MET SPECIFICATION, AND AN EXISTING TECHNICAL SUMMARY HAS BEEN DOCUMENTED FOR ROOT CAUSE ANALYSIS ON BALLOON BURSTS IN A CALCIFIED AORTIC ANNULUS. THE TECHNICAL SUMMARY IS APPLICABLE TO THIS COMPLAINT BECAUSE CALCIFICATION WAS PRESENT IN THE ANNULUS AND COULD HAVE CAUSED THE BALLOON TO BURST. AS SUCH, AN ENGINEERING EVALUATION IS NOT REQUIRED. THE COMPLAINTS FOR ¿¿BALLOON- BURST¿, ¿DELIVERY SYSTEM- WITHDRAWAL DIFFICULTY-THROUGH SHEATH¿ AND ¿DISTAL TIP, NOSE TIP- SEPARATED¿ WERE CONFIRMED. AVAILABLE INFORMATION THEREFORE SUGGESTS THAT PATIENT FACTORS (CALCIFICATION) AND/OR PROCEDURAL FACTORS (EXCESSIVE FORCE USED DURING WITHDRAWAL) LIKELY CONTRIBUTED TO THE COMPLAINT EVENTS. SINCE THE OCCURRENCE RATE DOES NOT EXCEED THE (B)(6) 2018 CONTROL LIMITS FOR THE TREND CATEGORY, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    UDI (B)(4). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN (B)(6), DURING THE IMPLANT OF THE 23MM SAPIEN 3 VALVE IN AORTIC POSITION BY TRANSAPICAL (TA) APPROACH, POST BAV, AT THE MOMENT OF VALVE DEPLOYMENT, THE CERTITUDE DELIVERY SYSTEM BALLOON BURST. DURING RETRIEVAL, DIFFICULTIES WERE ENCOUNTERED TO RETRACT THE BALLOON BACK INTO THE SHEATH. THE DISTAL TIP OF THE CERTITUDE DELIVERY SYSTEM WAS SEPARATED SPONTANEOUSLY. A NEW SHEATH AND CERTITUDE WERE USED TO FULLY EXPAND THE SAPIEN 3 VALVE. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848302 EDWARDS CERTITUDE DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9620TA23 61019840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention