EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
Report
- Report Number
- 2015691-2024-09329
- Event Type
- Injury
- Date Received
- December 5, 2024
- Date of Event
- January 1, 2021
- Report Date
- December 12, 2024
- Manufacturer
- EDWARDS LIFESCIENCES LLC
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED UPON AVAILABILITY OF RELATED MANUFACTURER REPORT NUMBERS. B4, G3, G6, H2, AND H11 HAVE BEEN UPDATED. THE ADDITIONAL INFORMATION IS PROVIDED IN H10.
THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM 2021-2023. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (JANUARY 1, 2021) WAS USED. IN THIS CASE, THE EXACT SHEATH MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SHEATH. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS TRANSFEMORAL SHEATH: K093877- RETROFLEX 3TM INTRODUCER SHEATH SET, P140031 - EDWARDS CERTITUDE INTRODUCER SHEATH SET, K200258- EDWARDS EXPANDABLE INTRODUCER SHEATH SET, AND K200258 EDWARDS ESHEATH+ INTRODUCER SET. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS PERFORATION OR DISSECTION OF VESSELS ARE KNOWN POTENTIAL RISKS OR ADVERSE EVENTS ASSOCIATED WITH THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND MAY REQUIRE INTERVENTION. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY WRITTEN BY EW, VASCULAR COMPLICATIONS ARE A WELL-RECOGNIZED COMPLICATION OF THE TRANSFEMORAL TVR PROCEDURE IN THIS ELDERLY POPULATION WITH MULTIPLE CO-MORBIDITIES. EDWARDS HAS REVIEWED MANY REPORTS, INCLUDING SCREENING DATA RECORDS AND SOURCE DOCUMENTATION OF VASCULAR COMPLICATIONS, AND HAS FOUND THAT THE ROOT CAUSE IS TYPICALLY RELATED TO A COMBINATION OF VESSEL SIZE, TORTUOSITY, AND CALCIFICATIONS. ALTHOUGH THE INCIDENCE IS DECREASING WITH SMALLER SHEATH/DELIVERY SYSTEM SIZES AND PHYSICIAN EXPERIENCE, THERE WILL CONTINUE TO BE CASES IN WHICH VASCULAR COMPLICATIONS WILL OCCUR. THE TRAINING MANUALS INSTRUCT ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUAL INSTRUCTS THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS, AS NEEDED. IT ALSO NOTES THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT THE TRANSFEMORAL PASSAGE OF THE DEVICES. THE IFU CONTRAINDICATES PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL/ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE SAPIEN VALVE (ALL MODELS) CAN BE DELIVERED TRANSFEMORALLY. ASSESSMENT OF LOCATION AND AMOUNT OF CIRCUMFERENTIAL CALCIUM WILL AID IN DETERMINING AREAS OF REDUCED VESSEL DIAMETERS. THE OPERATORS ARE TRAINED TO MEASURE MINIMUM VESSEL DIAMETER TAKING CALCIUM INTO ACCOUNT. THE TRAINING MANUAL ALSO LISTS THE MINIMUM RECOMMENDED VESSEL SIZE FOR EACH SIZE DEVICE. DESPITE THE BEST SCREENING TOOLS, A SMALL PERCENTAGE OF PATIENTS WILL HAVE FEMORAL/ILIAC VESSELS THAT ARE NOT AMENABLE TO THE TRANS-FEMORAL APPROACH OR WHERE INCREASED RESISTANCE IS ENCOUNTERED DURING INSERTION OF DEVICES. IN MANY CASES, THE VESSEL MINIMUM LUMINAL DIAMETER (MLD) MAY BE BORDERLINE OR BELOW THE INDICATED SIZE. IN ADDITION, SIGNIFICANT CALCIFICATION AND/OR TORTUOSITY, NOT ALWAYS APPRECIABLE ON IMAGING, COULD BE CONTRIBUTING FACTORS TO THE EVENT. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 14F SHEATH IS 5.5 MM AND FOR A 16F SHEATH IS 6.0 MM. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE DETAILS OF THE EVENT WERE OBTAINED THROUGH AN ARTICLE AND DO NOT PROVIDE SUFFICIENT INFORMATION TO DETERMINE A ROOT CAUSE, BUT MAY BE RELATED TO THE MECHANISM AND/OR FACTORS MENTIONED ABOVE, INCLUDING PATIENT FACTORS (END STAGE RENAL DISEASE AND HEMODIALYSIS, WHICH CAN CONTRIBUTE TO SEVERE CALCIFICATION). 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. THIS IS ONE OF SEVEN MANUFACTURING REPORTS BEING SUBMITTED FOR THIS CASE. ADDITIONAL REPORT NUMBERS TO BE DETERMINED AND PROVIDED IN H10 FOLLOWING THEIR SUBMISSION.
THROUGH REVIEW OF THE MEDICAL ARTICLE "IMAGING CHARACTERISTICS AND CLINICAL OUTCOMES OF HEMODIALYSIS VS. NON-HEMODIALYSIS PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT: A JAPANESE SINGLE-CENTER EXPERIENCE", BASELINE CHARACTERISTICS AND OUTCOMES UP TO 1 YEAR WERE COMPARED BETWEEN ESRD-HD PATIENTS AND NON ESRD-HD PATIENTS. 287 PATIENTS WHO UNDERWENT TAVR WITH THE SAPIEN 3 BETWEEN FEBRUARY 2021 AND JANUARY 2023. OF 287, 59 WERE ESRD-HD PATIENTS AND 228 WERE NON ESRD-HD PATIENTS. THE FOLLOWING EVENT WAS IDENTIFIED: DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT WITH A SAPIEN 3 VALVE, ONE PATIENT WITH ESRD-HD EXPERIENCED A MAJOR VASCULAR COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1413618 | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES LLC | ESHEATH UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |