TA DELIVERY SYSTEM UNKNOWN
Report
- Report Number
- 2015691-2019-01661
- Event Type
- Malfunction
- Date Received
- May 9, 2019
- Date of Event
- April 16, 2019
- Report Date
- April 16, 2019
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICE WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION WITH THE INFLATION BALLOON AND GUIDEWIRE/NOSE TIP ASSEMBLY SEPARATED. KINKS WERE PRESENT ON THE GUIDEWIRE LUMEN, LIKELY FROM THE PACKAGING CONDITION. REVIEW OF PROVIDED IMAGERY REVEALED THAT CALCIFICATION WAS PRESENT IN THE PATIENT ANNULUS. THE RETURNED DEVICE WAS VISUALLY INSPECTED. THERE WAS RADIAL AND LONGITUDINAL BALLOON BURST. THERE WAS A BOND FAILURE BETWEEN THE GUIDEWIRE SHAFT AND Y-CONNECTOR. ADHESIVE WAS PRESENT WHERE THE TWO COMPONENTS MATE. NO RELEVANT FUNCTIONAL TESTING WAS ABLE TO BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. SINGLE WALL THICKNESS OF THE INFLATION BALLOON NEAR TO THE OBSERVED BURST WAS MEASURED. THICKNESS MEASUREMENTS DEVIATING FROM THE SPECIFICATION COULD CONTRIBUTE TO THE REPORTED EVENT AND/OR BE INDICATIVE OF A MANUFACTURING NONCONFORMANCE. THE BALLOON SINGLE WALL THICKNESS AT ALL MEASURED LOCATIONS WERE WITHIN SPECIFICATION. THE COMPLAINTS WERE CONFIRMED, BUT NO MANUFACTURING NON-CONFORMITIES WERE FOUND IN THE RETURNED SAMPLE. REVIEW OF DIMENSIONAL AND VISUAL INSPECTIONS REVEALED NO INDICATION OF NON-CONFORMANCES. REVIEW OF PROVIDED IMAGERY REVEALED THAT CALCIFICATION WAS PRESENT IN THE PATIENT ANNULUS. BASED ON THIS INFORMATION, 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. IT ALSO DETAILS WHY BALLOONS ARE SUBJECT TO INCREASED RISK OF BURST IN A CALCIFIED ANNULUS. THE PRESENCE OF CALCIFICATION CAN CREATE A CHALLENGING ANATOMY FOR BALLOON INFLATION. WHILE THE BALLOONS ARE SUFFICIENTLY DESIGNED AND TESTED FOR RATED BURST PRESSURES WELL ABOVE THEIR INFLATION PRESSURE, CALCIFIED NODULES CAN COMPROMISE THE STRUCTURE OF THE BALLOON WALL VIA FOLLOWING MECHANISMS SUCH AS PUNCTURE, LOCAL OVERSTRETCHING, OPEN CELL IMPINGEMENT, OR STRESS CONCENTRATION. 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). ADDITIONALLY, THE TECHNICAL SUMMARY APPLIES TO COMPLAINTS CODED FOR ¿BALLOON ¿ BURST¿ WHICH ALSO RESULTED IN DIFFICULTIES WITHDRAWING THE DELIVERY SYSTEM AND/OR SUBSEQUENT SEPARATION OF THE DISTAL END (E.G. BALLOON, NOSE TIP, GUIDEWIRE LUMEN) OF THE DELIVERY SYSTEM. AS SUCH, THE REPORTED EVENTS DISCUSSED IN THIS COMPLAINT ARE LIKELY RELATED TO THE DETAILS OUTLINED IN THE TECHNICAL SUMMARY. IN THIS CASE, A BALLOON BURST WOULD HAVE CREATED DIFFICULTY WITHDRAWING THE DELIVERY SYSTEM INTO THE SHEATH, AS THE ALTERED BALLOON PROFILE WOULD HAVE LIKELY BECOME CAUGHT ON THE TIP OF THE SHEATH. EXTRA FORCE EXERTED TO OVERCOME THE WITHDRAWAL DIFFICULTY MAY HAVE CONTRIBUTED TO THE NOSE TIP SEPARATING. AVAILABLE INFORMATION THEREFORE SUGGESTS THAT PATIENT (CALCIFICATION) AND/OR PROCEDURAL (WITHDRAWAL OF A RUPTURED BALLOON) FACTORS 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 SINCE NO EDWARDS DEFECT WAS IDENTIFIED IN THE EVALUATION, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.
REFERENCE CAPA-20-00141.
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. 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. THE ¿ANNULUS¿ MAY REFER TO A PATIENT¿S NATIVE ANNULUS (IN THE AORTIC, PULMONIC, MITRAL, OR TRICUSPID POSITION), OR A PREVIOUSLY IMPLANTED THV, SURGICAL VALVE, OR RING IN THE AORTIC, PULMONIC, MITRAL OR TRICUSPID POSITION. ANALYSIS REVEALED THAT THESE TYPES OF RUPTURES ARE TYPICALLY CAUSED BY PUNCTURE FROM CALCIUM ON THE ANNULUS WHEN THE INFLATED DELIVERY SYSTEM BALLOON COMES IN CONTACT WITH THE 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. IN THIS CASE, THE EXACT CAUSE OF THE BALLOON BURST IS UNKNOWN, BUT MAY BE RELATED TO THE MECHANISM ABOVE. 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.
CORRECTION TO CODES IN F10 PER THE ADDITIONAL REVIEW OF THE CASE. THE CODE ADDITION DOES NOT EFFECT THE REST OF THE REPORT. UPDATE TO MA/510K TO REFLECT WHEN CODE CHANGE WAS MADE.
AS REPORTED BY OUR AFFILIATES IN GERMANY, DURING DEPLOYMENT OF THE 26MM SAPIEN 3 VALVE BY TA APPROACH IN AORTIC POSITION, THE CERTITUDE BALLOON BURST. BAV WAS PERFORMED PRIOR TO DEPLOYMENT WITHOUT ISSUES. DESPITE THIS, THE VALVE WAS WELL IMPLANTED. WHILE ATTEMPTING TO RETRIEVE THE DELIVERY SYSTEM, THE TIP SEPARATED. WITH A SNARE IT WAS POSSIBLE TO REMOVE THE TIP TOGETHER WITH THE SHEATH. TEE SHOWED A WELL IMPLANTED VALVE AND THE PATIENT WAS TRANSFERRED TO ICU.
IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, THIS REPORT WILL REFLECT AN UNKNOWN TA DELIVERY SYSTEM. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS TA DELIVERY SYSTEM ARE LISTED BELOW: P110021- EDWARDS ASCENDRA DELIVERY SYSTEM;; P130009 - EDWARDS ASCENDRA+ DELIVERY SYSTEM; P140031- EDWARDS CERTITUDE DELIVERY SYSTEM. INVESTIGATION OF THIS EVENT IS ONGOING.
AS REPORTED BY OUR AFFILIATES IN (B)(6), DURING THE TRANSAPICAL PROCEDURE, THE BALLOON BURST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387309 | TA DELIVERY SYSTEM UNKNOWN | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | TA DELIVERY SYSTEM UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |