EDWARDS COMMANDER DELIVERY SYSTEM
Report
- Report Number
- 2015691-2023-18104
- Event Type
- Malfunction
- Date Received
- December 5, 2023
- Date of Event
- January 1, 2021
- Report Date
- January 12, 2024
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
SUPPLEMENTAL REPORT REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2023-17939, AND 2015691-2023-18143.
CORRECTION TO B4, G3, G6, H2, H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION, AND H10 TO REFLECT TO NO PRODUCT RETURNED EVALUATION. AS NO PRODUCT WAS RETURNED, NO VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL TESTING COULD BE PERFORMED. A DHR REVIEW AND A LOT HISTORY WERE UNABLE TO BE PERFORMED AS NO WORK ORDER NUMBER WAS PROVIDED. AS NO DEVICE WAS RETURNED AND THERE IS NO EVIDENCE TO SUPPORT A MANUFACTURING/DESIGN DEFECT POTENTIALLY CONTRIBUTED TO THE COMPLAINT, A MANUFACTURING MITIGATION REVIEW IS NOT REQUIRED. AVAILABLE IMAGERY WAS EVALUATED AND THE VALVE WAS ALIGNED BETWEEN MARKERS AND ADVANCED TOWARDS AORTIC VALVE. THE VALVE WAS ALSO SHOWN BEING RETRACTED BACK INTO THE ESHEATH. THE IFU FOR S3U WITH COMMANDER DELIVERY SYSTEM, DEVICE PROCEDURAL TRAINING MANUAL, AND IFU FOR S3U WITH COMMANDER DELIVERY SYSTEM. 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 BALLOON LEAK WAS UNABLE TO BE CONFIRMED DUE TO NO DEVICE OR APPLICABLE IMAGERY PROVIDED. NO MANUFACTURING NON-CONFORMANCE WAS IDENTIFIED DURING THE EVALUATION. DUE TO UNAVAILABILITY OF THE LOT NUMBER, A DHR OR LOT HISTORY WAS UNABLE TO BE PERFORMED. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. DURING MANUFACTURING BALLOONS ARE 100% VISUALLY INSPECTED AT SEVERAL DIFFERENT STEPS AND DEVICES ARE 100% LEAK TESTED. THEREFORE, IT IS UNLIKELY THAT THE DELIVERY SYSTEM LEFT THE MANUFACTURING SITE WITH BALLOON DAMAGE. ADDITIONALLY, THERE WAS NO NOTE OF ABNORMALITIES OR LEAKAGE ON THE DELIVERY SYSTEM DURING DEVICE PREPARATION AND DE-AIRING, SUGGESTING THAT THERE WAS NO ISSUE WITH THE DEVICE WHEN REMOVED FROM PACKAGING. AS REPORTED , ''UNDER RAPID PACING AND BALLOON EXPANSION, THE BALLOON FAILED TO INFLATE, SUGGESTING SEPARATION OF THE BALLOON FROM THE END OF THE CATHETER. BLOOD CAME BACK INTO THE IN DEFLATOR''. BALLOON LEAK MAY RESULT FROM DAMAGE TO THE BALLOON MATERIAL SUSTAINED THROUGH A COMBINATION OF PATIENT AND/OR PROCEDURAL FACTORS. THE STRUCTURAL INTEGRITY OF THE BALLOON MAY BE COMPROMISED VIA IMPROPER DEVICE PREPARATION (CRIMPING) OR IMPROPER VALVE ALIGNMENT TECHNIQUES (EXCESSIVE MANIPULATION WITHIN TORTUOUS ANATOMY). IT MAY ALSO BE POSSIBLE FOR THE BALLOON TO BECOME DAMAGED DURING DELIVERY SYSTEM ADVANCEMENT THROUGH SHEATH/VASCULATURE VIA UNFAVORED INTERACTIONS BETWEEN THE BALLOON AND THE CRIMPED THV (TYPICALLY PROMOTED BY CALCIFIED, TORTUOUS, AND/OR VESSEL-RESTRICTED ANATOMY VIA NON-COAXIAL ADVANCEMENT ANGLES). IN THIS CASE, DUE TO LIMITED INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. SINCE NO DEVICE PROBLEM WAS IDENTIFIED AFFECTING DISTRIBUTED PRODUCT, NO PRA IS REQUIRED PER (B)(4) REV. O. SINCE NO EDWARDS DEFECT, WHICH COULD HAVE RESULTED IN THE COMPLAINT, WAS CONFIRMED, NO PREVENTATIVE OR CORRECTIVE ACTIONS ARE REQUIRED.
INVESTIGATION ONGOING. THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THE DATE OF THE IMPLANT AND DATE OF EVENT IS UNKNOWN. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, THE ARTICLE WAS SUBMITTED FOR PUBLICATION ON 2023 MAY 30. THEREFORE, THE 'SUBMISSION FOR PUBLICATION DATE' WAS USED AS THE OCCURRENCE DATE. ARTICLE CITATION: WALEED M, ARUNOTHAYARAJ S, MCGRATH S, MICHAIL M, COCKBURN J, HILDICK-SMITH D. NOVEL ADAPTATIONS IN PERCUTANEOUS RIGHT TRANSAXILLARY ACCESS FOR TRANSCATHETER AORTIC VALVE IMPLANTATION USING THE SAPIEN ULTRA VALVE. J INVASIVE CARDIOL. 2023 JUL;35(7):E355-E364. PMID: 37769621. H3 OTHER TEXT : LITERATURE REPORTING, NO INDICATION OF DEVICE RETURN
AS REPORTED, BY OUR AFFILIATES IN UNITED KINGDOM, THROUGH REVIEW OF MEDICAL ARTICLE " NOVEL ADAPTATIONS IN PERCUTANEOUS RIGHT TRANSAXILLARY ACCESS FOR TRANSCATHETER AORTIC VALVE IMPLANTATION USING THE SAPIEN ULTRA VALVE ", CORRESPONDING AUTHOR MOHAMMAD WALEED, THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: IT WAS A CASE OF A 81-YEAR-OLD MALE WHO UNDERWENT AN IMPLANTATION OF A 26MM SAPIEN 3 ULTRA VALVE IN AORTIC POSITION BY TRANSAXILLARY APPROACH. DURING THE PROCEDURE, THE 26 SAPIEN 3 ULTRA VALVE WAS ADVANCED INTO POSITION ACROSS THE ANNULUS. USING THE RETROFLEX OF THE ES COMMANDER SYSTEM, THE S3 VALVE WAS POSITION TO ALLOW CO-AXIAL ALIGNMENT. UNDER RAPID PACING AND BALLOON EXPANSION, THE BALLOON FAILED TO INFLATE, SUGGESTING SEPARATION OF THE BALLOON FROM THE END OF THE CATHETER. BLOOD CAME BACK INTO THE INDEFLATOR. THE SURGEON WAS ABLE TO RECAPTURE THE VALVE INTO THE END OF THE ESHEATH SUCCESSFULLY. THEN, THEY PUT IN A SECOND INTRODUCER, AND A SECOND 26 MM S3 ULTRA VALVE WAS USED. ARTICULATION OF THE FLEXWHEEL WAS APPLIED AND EXCELLENT CO-AXIAL ALIGNMENT WAS ACHIEVED WITH THE BALLOON CATHETER ALONG THE OUTER CURVATURE OF THE ASCENDING AORTA. THIS WAS PUT IN A GOOD POSITION JUST BELOW THE AORTIC ANNULUS. THE PATIENT WAS SUCCESSFULLY DISCHARGED FROM THE HOSPITAL AFTER 3 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2123027 | EDWARDS COMMANDER DELIVERY SYSTEM | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9610TF26U | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male |