EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
Report
- Report Number
- 2015691-2020-11618
- Event Type
- Death
- Date Received
- April 23, 2020
- Date of Event
- March 25, 2020
- Report Date
- March 25, 2020
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- PMA / PMN Number
- P140031
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
SUPPLEMENTAL REPORT TO ADD NOE STATEMENT IN B5 SECTION.
SUPPLEMENTAL REPORT TO RESUBMIT H6 CODES.
THIS REPORT SUMMARIZES <NOE> 23 </NOE> DEATH EVENTS OF CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER FOR THE SAPIEN 3 FOR (B)(6) 2020.
EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 23 DEATH EVENTS OF CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER FOR THE SAPIEN 3 IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 3.47. PER THE INSTRUCTIONS FOR USE, CONDUCTION SYSTEM DEFECTS (HEART BLOCK) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY, DEPLOYMENT OF THE PROSTHETIC VALVE, AND THE OVERALL TAVR PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE TAVR PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY -CONDUCTION DISTURBANCES/ HEART BLOCK, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TAVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PRE-OPERATIVE CO-MORBID STATUS, THE DEGREE AND BULKINESS OF AORTIC VALVE AND ANNULAR CALCIFICATION, INTER-VENTRICULAR SEPTAL THICKNESS, PRE-EXISTING ELECTROCARDIOGRAM ABNORMALITIES, THE DEPTH OF PROSTHESIS IMPLANTATION, AND THE PROFILE OF THE IMPLANTED PROSTHESIS. UNLIKE CONVENTIONAL AVR, WHERE THERE MAY BE LOCALIZED TRAUMA DUE TO DECALCIFICATION OF THE ANNULUS AND/OR SUTURE PLACEMENT IN THE PROXIMITY OF THE AV NODE OR THE BUNDLES, TAVR MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TAVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING TAVR OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. IN THIS CASE, THE CONDUCTION DISTURBANCE IS LIKELY RELATED TO THE MECHANISM DESCRIBED 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. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE: (B)(4).
THV/TVT REGISTRY ALTERNATIVE SUMMARY REPORTING (ASR) ADVERSE EVENT SUBMISSION FOR FEBRUARY 2020 DATA EXTRACT FOR AORTIC DEATHS FOR THE SAPIEN 3. FEBRUARY 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q3 2019 (JULY 1 - SEPTEMBER 30). THIS REPORT SUMMARIZES 23 DEATH EVENTS OF CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER FOR THE SAPIEN 3 FOR FEBRUARY 2020. THE AGE RANGE FOR THESE EVENTS ARE FROM 59 TO 94. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 18 MALE AND 5 FEMALE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 454439 | EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY | NPT | EDWARDS LIFESCIENCES | 9600TFX | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 0 | 80 YR | Death | ||
| 1 | 80 YR | Death |