EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2026-13909
- Event Type
- Death
- Date Received
- April 7, 2026
- Date of Event
- March 19, 2026
- Report Date
- April 27, 2026
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- UDI-DI
- 00690103217902
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR ADDITIONAL INFORMATION BEING RECEIVED. THE FOLLOWING SECTIONS HAVE BEEN ADDED: B2, B4, B5, G3, G6, H1, H2, H6 (IMPACT CODE AND TYPE OF INVESTIGATION), H11. THE PREVIOUSLY SUBMITTED INVESTIGATION REMAINS UNCHANGED.
PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURY INCLUDING HEMATOMA, PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, ATRIUM, SEPTUM, MYOCARDIUM OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND MAY REQUIRE INTERVENTION. ACCORDING TO THE DEVICE TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, CARDIAC/AORTIC HEMATOMA, OR ANNULAR RUPTURE DURING THE TVR PROCEDURE INCLUDE SIGNIFICANT VALVE OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION, AND NARROW CALCIFIED SINOTUBULAR JUNCTION. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. THE SAPIEN TRANSCATHETER HEART VALVE (ALL MODELS) RELIES CALCIUM TO SECURELY ANCHOR IN THE LANDING ZONE. DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES, THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE, AND PROCEDURAL SUCCESS. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE THE PATIENT'S HEAVILY CALCIFIED BICUSPID RAPHE COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. 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 THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. 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 MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.
THE PASSED AWAY AFTER SURGERY.
AS REPORTED BY OUR (B)(6) AFFILIATES, DURING IMPLANT OF A 26'MM SAPIEN 3 ULTRA RESILIA VALVE, AN ANNULAR RUPTURE OCCURRED WHILE DEPLOYING THE VALVE. THE RUPTURE WAS ATTRIBUTED TO THE PRESENCE OF A HEAVILY CALCIFIED BICUSPID RAPHE AND A TEAR INVOLVING THE LEFT CORONARY CUSP SINUS. NO DEVICE DIFFICULTIES WERE REPORTED. THE PATIENT WAS CONVERTED TO SURGERY FOR REPAIR OF THE RUPTURE, AND THE TRANSCATHETER VALVE WAS EXPLANTED AND REPLACED WITH A SURGICAL AORTIC VALVE. THE PATIENT'S OUTCOME REMAINS UNKNOWN AND FOLLOW UP IS ONGOING TO OBTAIN FINAL STATUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 861618 | EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9755RSL29 | 00690103217902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Required Intervention| D |