BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPIEN 3 ULTRA VALVE

    MDR report key: 12292122 · Received August 8, 2021

    Report

    Report Number
    2015691-2021-04570
    Event Type
    Malfunction
    Date Received
    August 8, 2021
    Date of Event
    July 12, 2021
    Report Date
    October 7, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NUMBER 2015691-2021-04569 AND 201569-2021-04810. ADDITIONAL INFORMATION WAS RECEIVED. THE VALVE AND DELIVERY SYSTEM DID NOT NAVIGATE PAST THE ESHEATH. THE SYSTEM WAS RETRIEVED AS A UNIT. A VALVE WAS IMPLANTED IN THE NATIVE AORTIC POSITION. THE PATIENT IS DOING WELL. THERE WAS NO HARM TO THE PATIENT. THE EVENT WAS CONSIDERED TO BE DUE TO AN OPERATOR ERROR WHILE INTRODUCING THE THV SYSTEM. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    IMAGERY WAS PROVIDED. DURING REVIEW IT WAS OBSERVED THE VALVE WAS CAUGHT AND TORE THE LINER NEAR THE TRANSITION AREA OF THE ESHEATH. TWO BENT STRUTS WERE NOTED AT THE INFLOW. THE VALVE WAS EXPOSED THROUGH THE LINER. CINE IMAGE REVEALED BENT STRUT AT THE INFLOW WHEN PASSING THROUGH THE SHEATH. THE DEVICES WERE RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION. DURING VISUAL ANALYSIS TWO (2) BENT STRUTS SEEN AT INFLOW WERE OBSERVED. ALL STRUTS EXPOSED THROUGH SKIRT, AND IT WAS NORMAL AFTER CRIMPED AND USED. THERE WAS A MINOR SIDEWAY BENDING ON ONE OF AN OUTFLOW STRUT. THE VALVE WAS EXPANDED AND A BENT STRUT AT THE OUTFLOW WAS SELF-CORRECTED AND ONE INFLOW STRUT NEAR TO C3 REMAINS FLARED OUT. THE LEAFLETS WERE WRINKLED AND DEHYDRATED DUE TO STORAGE CONDITION (PROLONG CRIMPING) DURING THE RETURN HANDLING PROCESS. THE FRAME WAS DISTORTED AND SLIGHTLY CANTED. NO FUNCTIONAL OR DIMENSIONAL TESTING WAS ABLE TO BE PERFORMED DUE TO DEVICE RETURN CONDITION (BENT STRUT, FRAME DISTORTED). DHR (DEVICE HISTORY REVIEW) DID NOT REVEAL ANY MANUFACTURING NONCONFORMANCE THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT EVENT. REVIEW OF LOT HISTORY REVEALED OTHER SIMILAR COMPLAINTS. DURING MANUFACTURING, THE VALVE FRAME AND COMPONENTS ARE INSPECTED SEVERAL TIMES THROUGHOUT THE MANUFACTURING PROCESS. THESE INSPECTIONS PERFORMED DURING MANUFACTURING PROCESS AND TESTING PERFORMED DURING PRODUCT VERIFICATION SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCES CONTRIBUTED TO THE REPORTED EVENTS. THE IFU, COMMANDER DELIVERY SYSTEM, DEVICE PREPARATION TRAINING MANUAL, AND PROCEDURAL TRAINING MANUAL WERE REVIEWED FOR INSTRUCTIONS/GUIDANCE FOR PREPARATION AND USE OF THE DEVICES. PER THE PROCEDURAL TRAINING MANUAL, DELIVERY SYSTEM INSERTION THROUGH SHEATH: CORRECTLY ORIENT DELIVERY SYSTEM AND CHECK POSITION BEFORE INSERTION. ORIENT THE DELIVERY SYSTEM WITH THE FLUSH PORT POINTING AWAY AND THE EDWARDS LOGO FACING UP. ENSURE DELIVERY SYSTEM IS LOCKED IN DEFAULT. PEEL AWAY LONGER LOADER FOR 20, 23, 26, AND, 29 MM VALVE SIZE. IF WORKING LENGTH IS INSUFFICIENT, PEEL AWAY THE LOADER TUBE AND REMOVE WHILE MAINTAINING DELIVERY SYSTEM AND WIRE POSITION. INSERTION FORCE THROUGH THE PARTIALLY EXPANDABLE PORTION CAN BE HIGHER THAN THE PUSH FORCE THROUGH THE FULLY EXPANDABLE PORTION. IN EXPECTATION OF HIGH FRICTION, USE SHORT MOVEMENTS AND PUSH DELIVERY SYSTEM CLOSER TO SHEATH HUB. PUSH FORCE CAN VARY DUE TO ANGLE OF ACCESS AND INSERTION, THV SIZE, VESSEL DIAMETER, TORTUOSITY AND DEGREE OF CALCIFICATION. FOLLOWING PROPER VALVE CRIMPING TECHNIQUE AND ENSURE VALVE IS DELIVERED AS STRAIGHT AS POSSIBLE. BE CAREFUL TO NOT BEND THE PROXIMAL END OF THE SHEATH WHEN INSERTING THE DELIVERY SYSTEM THROUGH THE SHEATH. IF PUSH FORCE IS TOO HIGH OR VALVE IS INITIALLY STUCK, ZOOM IN AND ROTATE THE C-ARM TO ENSURE VALVE AND SHEATH ARE NOT DAMAGED. IF DAMAGED, RETRACT VALVE IN SHEATH SLIGHTLY. REMOVE VALVE AND SHEATH TOGETHER AS SINGLE UNIT AND REPLACE. IF PUSH FORCE IS HIGH, CONSIDER SLIGHTLY PULLING BACK THE SHEATH 1 TO 2 CM WHILE ADVANCING THE THV/DELIVERY SYSTEM. IF PUSH FORCE IS TOO HIGH OR VALVE IS STILL STUCK, REMOVE VALVE AND SHEATH TOGETHER AS A SINGLE UNIT AND REPLACE. DO NOT OVER MANIPULATE THE SHEATH AT ANY TIME. CAUTION: THE THV SHOULD NOT BE ADVANCED THROUGH THE SHEATH IF THE SHEATH TIP IS NOT ABOVE THE RENAL ARTERIES. KEEP LOADER INSERTED IN SHEATH UNTIL JUST PRIOR TO DELIVERY SYSTEM REMOVAL IF USING THE SHORTER NON PEEL AWAY LOADER. NO IFU/TRAINING DEFICIENCIES WERE IDENTIFIED. 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. THE COMPLAINT WAS CONFIRMED THROUGH THE DEVICE EVALUATION. NO POTENTIAL MANUFACTURING NONCONFORMANCE WERE IDENTIFIED. REVIEW OF THE DHR, LOT HISTORY, COMPLAINT HISTORY REVIEW AND MANUFACTURING MITIGATIONS DID NOT PROVIDE ANY INDICATIONS THAT A MANUFACTURING NONCONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. PER THE REPORT, THE PHYSICIAN EXPERIENCED DIFFICULTY IN ADVANCING THE COMMANDER FROM THE PARTIALLY EXPANDABLE PORTION. WHEN IT WAS SCREENED, A BEND OF STENT FRAME WAS QUITE VISIBLE. THE ESHEATH AND SYSTEM WERE REMOVED AS A SINGLE UNIT. THERE WAS NO HARM CAUSED TO PATIENT. THE SHEATH WAS DAMAGED. A NEW SYSTEM WAS CRIMPED AND IMPLANTED SUCCESSFULLY. AS REPORTED, THE PATIENT HAD A MILD TORTUOSITY AND MILD CALCIFICATION ACCESS VESSEL. IN ADDITION, IT WAS NOTED THAT THERE WAS AN ERROR INSERTING THE LOADER TO THE DELIVERY SYSTEM. PER THE IFU AND TRAINING MANUAL, THE LOADER MUST BE COMPLETELY INSERTED INTO THE SHEATH BEFORE THE DELIVERY SYSTEM AND VALVE INSERTION. THE LOADER IS USED TO FACILITATE A SMOOTH TRANSITION OF THE CRIMPED VALVE THROUGH THE SHEATH HUB. IF THE LOADER WAS NOT COMPLETELY INSERTED THROUGH THE SHEATH, THE VALVE CAN BE EXPOSED AND INTERACT WITH THE HEMOSTASIS VALVES WITHIN THE SHEATH HUB DURING DEVICE INSERTION, CAUSING DAMAGE TO THE FRAME. FURTHERMORE, THE PRESENCE OF TORTUOSITY AND CALCIFICATION COULD ALSO CREATE THE CHALLENGING PATHWAY DURING THE DELIVERY SYSTEM (WITH CRIMPED VALVE) INSERTION THROUGH SHEATH, AND IT LED TO HIGH RESISTANCE AND PUSH FORCE. IF EXCESSIVE FORCE WAS APPLIED TO OVERCOME THE RESISTANCE, IT COULD RESULT IN OBSERVED BENT STRUTS AND SUBSEQUENTLY TEARING THE SHEATH LINER. THESE PATIENT AND PROCEDURAL FACTORS, IN CONJUNCTION WITH THE EXPOSED APICES OF THE CRIMPED S3U THV, MAY INCREASE THE RATE OF THE THV GETTING CAUGHT ON THE SHEATH, PREVENTING FURTHER ADVANCEMENT. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (TORTUOSITY/CALCIFICATION) AND/OR PROCEDURAL FACTORS (LOADER NOT FULLY INSERTED, EXCESSIVE DEVICE MANIPULATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. THE COMPLAINT FOR FRAME DAMAGE WAS CONFIRMED. NO MANUFACTURING NONCONFORMANCES WERE ABLE TO BE IDENTIFIED. AVAILABLE INFORMATION SUGGESTS THAT PATIENT (CALCIFICATION, TORTUOSITY) AND PROCEDURAL FACTORS (LOADER NOT FULLY INSERTED, EXCESSIVE DEVICE MANIPULATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED. A PRODUCT RISK ASSESSMENT (PRA) AND CAPA WERE PREVIOUSLY INITIATED FOR THIS FAILURE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 1

    THIS IS TWO OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THIS REPORT REPRESENTS THE VALVE USED DURING THE CASE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN (B)(6), A DURING IMPLANT OF A 26 MM SAPIEN 3 ULTRA VALVE USING TRANSFEMORAL APPROACH, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM THROUGH THE PARTIALLY EXPANDABLE PORTION OF THE ESHEATH. THE VALVE FRAME WAS OBSERVED TO HAVE A BENT STRUT. THE VALVE, DELIVERY SYSTEM AND ESHEATH WERE REMOVED AS A SINGLE UNIT. UPON REMOVAL, THE ESHEATH WAS FOUND TO BE DAMAGED. PER A PHOTO PROVIDED, THE LINER WAS TORN AND DELAMINATED, AND THERE WAS A SHEATH LINER STRAND. A NEW SYSTEM WAS USED AND A VALVE WAS IMPLANTED SUCCESSFULLY. THERE WAS NO HARM CAUSED TO THE PATIENT. THE PATIENTS ACCESS VESSEL MINIMUM LUMINAL DIAMETER WAS 6.5MM, AND HAD MILD CALCIFICATION AND MILD TORTUOSITY. DURING PREDECONTAMINATION EVALUATION OF THE RETURNED DEVICE, THERE WAS LEAKAGE WAS OBSERVED ON THE DELIVERY SYSTEM. THE BALLOON APPEAR FULLY INTACT; HOWEVER, THERE WAS LEAKAGE FROM THE FLEX SHAFT WHEN APPLYING LIQUID TO THE BALLOON PORT (WHEN THE 3 WAY STOPCOCK WAS LOCKED ON HANDLE). THERE WAS LEAKAGE PRESENT AT THE 3 WAY STOPCOCK WHEN LIQUID WAS APPLIED TO THE BALLOON PORT (WHEN THE 3 WAY STOPCOCK WAS UNLOCKED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189229 SAPIEN 3 ULTRA VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750TFX26 NA

    Patients

    Seq Age Sex Outcome Treatment
    1