EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2024-07407
- Event Type
- Death
- Date Received
- September 26, 2024
- Date of Event
- September 3, 2024
- Report Date
- October 29, 2024
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS IS ONE OF TWO REPORTS BEING SUBMITTED FOR THIS CASE. 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, HEMATOMA, OR ANNULAR RUPTURE DURING THE TVR PROCEDURE INCLUDE SIGNIFICANT TRANSCATHETER HEART VALVE OVERSIZING, 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 VALVE (ALL MODELS) RELIES ON VALVE CALCIUM TO SECURELY ANCHOR TO 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 CARDIOVASCULAR 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. PERICARDIAL EFFUSION IS AN ABNORMAL ACCUMULATION OF FLUID IN THE PERICARDIAL CAVITY. BECAUSE OF THE LIMITED AMOUNT OF SPACE IN THE PERICARDIAL CAVITY, FLUID ACCUMULATION WILL LEAD TO AN INCREASED INTRA PERICARDIAL PRESSURE WHICH CAN NEGATIVELY AFFECT HEART FUNCTION. WHEN THERE IS A PERICARDIAL EFFUSION WITH ENOUGH PRESSURE TO ADVERSELY AFFECT HEART FUNCTION, THIS IS CALLED CARDIAC TAMPONADE. IT CAN BE CAUSED BY A VARIETY OF LOCAL AND SYSTEMIC DISORDERS, OR IT MAY BE IDIOPATHIC. PERICARDIAL EFFUSIONS CAN BE ACUTE OR CHRONIC, AND THE TIME COURSE OF DEVELOPMENT HAS A SIGNIFICANT IMPACT ON THE PATIENT'S SYMPTOMS. IN TVR PATIENTS, IT MAY BE CAUSED BY GUIDEWIRE PERFORATIONS OR ANNULAR RUPTURES. IN TRANSAPICAL PATIENTS, POSTOPERATIVE PERICARDIAL EFFUSIONS ARE COMMON, MOST WILL RESOLVE SPONTANEOUSLY, AND SOME MAY REQUIRE INTERVENTION. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE PROCEDURAL FACTORS (MANIPULATION DURING RESUSCITATION) 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.
A SUPPLEMENTAL MDR IS BEING SUBMITTED DUE TO CORRECTION AND ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN UPDATED: B.4, E.1 (PHONE NUMBER) G.3, G.6, AND H.2. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN CORRECTED. H.6 (CLINICAL CODE FROM 3271 TO 1762), (INVESTIGATION CONCLUSIONS FROM 4311 TO 4315) AND H.10. PER THE INSTRUCTIONS FOR USE (IFU), CARDIAC ARREST IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BALLOON VALVULOPLASTY, THE USE OF LOCAL AND/OR GENERAL ANESTHESIA, BIOPROSTHETIC HEART VALVES, AND THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE. CARDIAC ARREST OCCURS WHEN A MAJOR CARDIOVASCULAR, RESPIRATORY, OR METABOLIC EVENT RESULTS IN THE INABILITY OF CARDIAC MUSCLE TO GENERATE SUFFICIENT FORCE IN RESPONSE TO ELECTRICAL DEPOLARIZATION. IT MAY BE CAUSED BY A PROFOUND CARDIOVASCULAR INSULT. EXAMPLES INCLUDE SEVERE PROLONGED HYPOXIA OR ACIDOSIS, EXTREME HYPOVOLEMIA, FLOW-RESTRICTING PULMONARY EMBOLUS, CARDIAC TAMPONADE, THROMBOSIS (CORONARY OR PULMONARY). THESE EVENTS MAY BE RELATED TO THE EDWARDS DEVICE IF IT IS ASSOCIATED WITH CARDIAC TAMPONADE, ANNULAR RUPTURE, OR OTHER EDWARD'S DEVICE-RELATED BLEED. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT HOWEVER DUE TO LIMITED INFORMATION PROVIDED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.
AS REPORTED BY OUR EDWARDS LIFESCIENCES AFFILIATE IN GERMANY, REGARDING A 29MM SAPIEN 3 TRANSCATHETER HEART VALVE IMPLANT IN AORTIC POSITION BY TRANSFEMORAL APPROACH, DURING THE PROCEDURE, THE VALVE WAS IMPLANTED A LITTLE TOO HIGH DUE TO CALCIFICATION IN THE RCC/NCC AREA. DUE TO MODERATE PARAVALVULAR LEAK, A SECOND 29MM SAPIEN 3 VALVE WAS IMPLANTED LOWER WITH A GOOD RESULT. THE PATIENT WAS UNSTABLE, AND RESUSCITATION WAS PERFORMED. ECHOGRAPHY REVEALED A NEW PERICARDIAL EFFUSION AFTER THE FIRST RESUSCITATION AND SECOND VALVE IMPLANTATION. PATIENT WAS CONVERTED TO SURGERY. NO VISIBLE ANNULUS RUPTURE OR INJURY TO THE VENTRICLES COULD BE OBSERVED, BUT AT ANGIOGRAPHIC A HYPOPERFUSION OF LCA/RIVA WAS VISIBLE. CORONARY ARTERY OBSTRUCTION COULD NOT BE CONFIRMED. THE PATIENT PASSED AWAY DURING THE SURGICAL PROCEDURE. AS PER MEDICAL OPINION, THE PERICARDIAL EFFUSION WAS ATTRIBUTED TO MANIPULATION DURING RESUSCITATION. POSSIBLE HEART FAILURE DUE TO REDUCED PERFUSION OF LCA/RIVA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1610498 | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | 9600TFX29 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Death |