SEE H10
Report
- Report Number
- 2015691-2018-00488
- Event Type
- Death
- Date Received
- February 13, 2018
- Date of Event
- November 2, 2017
- Report Date
- January 23, 2018
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYE
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
THE REPORT OF CENTRAL REGURGITATION COULD NOT BE CONFIRMED THROUGH VISUAL OBSERVATIONS. X-RAY DEMONSTRATED WIREFORM INTACT. MECHANICAL DAMAGE WAS OBSERVED ON LEAFLET 3 NEAR COMMISSURE 1. THE WIREFORM WAS EXPOSED ON COMMISSURES 1 AND 2. NO INTRAOPERATIVE ECHOCARDIOGRAM WAS PROVIDED, THUS THE REPORTED SEVERE CENTRAL REGURGITATION IN VIVO COULD NOT BE CONFIRMED. IN VITRO TESTING WAS PERFORMED AND THE IMMEDIATE FUNCTIONALITY OF THE VALVE WAS NORMAL. THERE WAS NO CENTRAL LEAKAGE PATH APPARENT DURING SIMULATED NORMAL PHYSIOLOGICAL PULSATILE FLOW TESTING OR DURING STATIC STEADY BACKFLOW LEAKAGE TESTING. THE REPORTED ¿SEVERE CENTRAL REGURGITATION¿ WAS NOT REPRODUCED DURING THE STANDARDIZED IN VITRO TESTING. REGURGITATION ORIGINATING FROM THE CENTRAL COAPTATION POINT OF A VALVE IS KNOWN AS CENTRAL LEAK, AND CAN OCCUR IF THE MOTION OF THE LEAFLET CUSPS IS RESTRICTED. CENTRAL LEAKS ARE CLASSIFIED AS ACUTE OR CHRONIC. ACUTE CENTRAL LEAKS OBSERVED IN THE PERI-OPERATIVE PERIOD USUALLY OCCUR FROM TECHNIQUE RELATED ISSUES SUCH AS SUTURE LOOPING OR CHORDAE ENTRAPMENT AT THE MITRAL POSITION. ANOTHER TECHNIQUE RELATED ISSUE IS VALVE DISTORTION DURING IMPLANT WHICH MAY RESULT IN A DROPPED LEAFLET OR ASYMMETRIC COAPTATION. THESE TECHNIQUES ARE NOT TYPICALLY THE RESULT OF PRODUCT MALFUNCTION; HOWEVER. THEY MAY CONTRIBUTE TO MILD TO SEVERE REGURGITATION AND IF UNDETECTED MAY REQUIRE REOPERATION. ALMOST ALL PERICARDIAL BIOPROSTHESIS HAVE SOME LEVEL OF CENTRAL LEAK POSTOPERATIVELY, ESPECIALLY WHEN SYSTOLIC PRESSURE IS LOW AND OR PRIOR TO PROTAMINE ADMINISTRATION AND IS USUALLY TOLERATED BY PATIENTS. CENTRAL REGURGITANT JETS OBSERVED IN STUDIES CONDUCTED ON THE PERIMOUNT PERICARDIAL VALVE IN THE IMMEDIATE POST-IMPLANT SETTING HAVE BEEN EVALUATED TO BE TRIVIAL IN MAGNITUDE, SIZE, AND VELOCITY. EDWARDS CONDUCTS MANUFACTURING AND INSPECTION TESTS TO ENSURE OPTIMUM FUNCTIONALITY OF EACH VALVE PRIOR TO FINAL DISTRIBUTION. SUCH TESTS USED TO EVALUATE IF EDWARDS ' VALVES MEET SPECIFICATION INCLUDE FORWARD FLOW TESTING TO DETERMINE THE PRESSURE GRADIENT ACROSS THE OPEN VALVE AND A COAPTATION TEST UNDER CONSTANT HYDROSTATIC BACK PRESSURE TO VISUALLY EVALUATE THE COAPTATION OF THE LEAFLETS. THE REPORTED EVENT COULD NOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. THE ROOT CAUSE OF THIS EVENT REMAINS INDETERMINABLE. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. OF NOTE, THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #2800; BRAND NAME: CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS; PMA #P860057/S001.
ECHO REVIEW DETERMINED THAT ¿IMMEDIATELY AFTER IMPLANTATION OF AN AORTIC BIOPROSTHESIS, NOTE IS MADE OF SEVERE AORTIC REGURGITATION. SUBMITTED IMAGES DO NOT ALLOW DEFINITIVE DETERMINATION OF THE JET ORIGIN; HOWEVER, MARKED JET ECCENTRICITY AND A FLOW CONVERGENCE ZONE APPARENTLY OUTSIDE THE SEWING RING SUGGEST A PARAVALVULAR ORIGIN. THE LV IS SMALL, HYPERTROPHIED, AND HYPERCONTRACTILE. AT THE COMPLETION OF THE CASE, THERE IS EVIDENCE OF DYNAMIC SUBVALVULAR LV OUTFLOW OBSTRUCTION THAT COULD BE EXACERBATED BY THE AFTERLOAD-REDUCING EFFECT OF AN INTRA-AORTIC BALLOON PUMP.¿ FUNCTIONAL TESTING OF THE RETURNED VALVE FOUND THAT THE TRF IS 2.2% COMPARED THE MAXIMUM ALLOWED 15% PER ISO584-2:2015. THERE WAS NO CENTRAL LEAKAGE PATH APPARENT DURING SIMULATED NORMAL PHYSIOLOGICAL PULSATILE FLOW TESTING, OR DURING STATIC STEADY BACKFLOW LEAKAGE TESTING. HOWEVER, THE RESULTS FROM IN VITRO TESTING MAY BE DIFFERENT FROM THOSE OBTAINED IN VIVO DUE TO DIFFERENCES IN HEMODYNAMIC AND ENVIRONMENTAL CONDITIONS. IN CONCLUSION, THE ORIGIN AND TYPE OF REGURGITATION COULD NOT BE CONCLUSIVELY DETERMINED. CUSTOMER REPORT OF SEVERE CENTRAL REGURGITATION COULD NOT BE CONFIRMED. IT IS POSSIBLE THAT THERE WAS PARAVALVULAR LEAK. ANNULAR CALCIFICATION IS A RISK FACTOR FOR THE DEVELOPMENT OF PERI-OPERATIVE PERIVALVULAR LEAK (PVL) AS THE BIOPROSTHESIS MAY NOT SEAT PROPERLY AFTER DEBRIDEMENT. TECHNIQUE RELATED FACTORS, SUCH AS INCORRECT VALVE SIZING, HAVE BEEN SHOWN TO CONTRIBUTE TO THE DEVELOPMENT OF PVL. UNDER SIZING CAN LEAD TO A GAP BETWEEN THE ANNULUS AND SEWING RING SINCE THE VALVE IMPLANTED IS TOO SMALL IN RELATION TO THE ANNULUS. ANATOMICAL FACTORS MAY CREATE DIFFICULTY SEATING THE BIOPROSTHETIC VALVE RESULTING IN PVL. THE ANATOMY OF THE ANNULUS MAY INDUCE MECHANICAL STRESSES ALONG THE RIGID BIOPROSTHETIC RING WHICH CAN INFLUENCE LONG-TERM VALVE PERFORMANCE AND DURABILITY. THE ANNULUS IS NOT A STATIC STRUCTURE AND HAS DYNAMIC CHARACTERISTICS WHICH HAVE BEEN SHOWN TO PLAY CRITICAL ROLE IN VALVE FUNCTION AND EFFICIENCY. A DISEASED OR RIGID ANNULUS CAN POTENTIALLY INCREASE THE MECHANICAL STRESS ON THE PROSTHETIC VALVE, LEADING TO PVL. IN THIS CASE, IT IS POSSIBLE THAT ANATOMICAL FACTORS OR IMPROPER DEBRIDEMENT OF THE CALCIUM COULD HAVE CAUSED A PVL.
EDWARDS RECEIVED NOTIFICATION THAT A BIOPROSTHETIC AORTIC VALVE WAS IMPLANTED THEN EXPLANTED DUE TO SEVERE CENTRAL REGURGITATION. AS PER MEDICAL DOCUMENTS, THE INDICATION FOR SURGERY WAS SEVERE SYMPTOMATIC AORTIC STENOSIS. THE NATIVE AORTIC VALVE HAD SEVERE CALCIFICATION IN THE ANNULUS AND ALSO IN THE LEAFLETS TO THE EXTENT THAT THE ANATOMY WAS SO DISTORTED THAT IT WAS NOT POSSIBLE TO CLEARLY DEFINE THE VALVE LEAFLETS. THE AVR WAS PERFORMED IN MINI-STERNOTOMY AND OBLIQUE AORTOTOMY. THE VALVE LEAFLETS WERE EXCISED WITH DIFFICULTY AND THE ANNULUS DECALCIFIED. THE SUBJECT DEVICE WAS IMPLANTED WITH 5X CONTINUES PROLENE SUTURES. WHILST SUTURING A SHEET OF CALCIUM WAS NOTED AT THE INTER-CORONARY COMMISSURE (R AND L). IT WAS NOT POSSIBLE TO PASS THE NEEDLE THROUGH THIS AND THEREFORE THE VALVE WAS REMOVED. IN DECALCIFYING THIS AREA A DEFICIT WAS CREATED IN THE AORTIC WALL WHICH WAS REPAIR WITH A 1 CM BOVINE PERICARDIAL PATCH. THE VALVE WAS AGAIN SUTURED WITH A GOOD SEATING AND THE AORTOTOMY WAS CLOSED. ON COMING OFF CPB, THERE WAS TURBULEN FLOW AT THE LEVEL OF THE VALVE WHICH WAS THOUGHT TO BE A TRANS-VALVULAR LEAK [ECHO IMAGES REQUESTED, PATIENT NOT COMPLETELY WEANED FROM BYPASS]. CPB WAS RECOMMENCED AND THE AORTA REOPENED. THE PATCH WAS PLICATED WITH 3-0 PROLENE BUT THIS DID NOT IMPROVE THE LEAK ON COMING OFF CPB FOR A SECOND TIME (PATIENT NOT COMPLETELY WEANED FROM BYPASS). CPB WAS RECOMMENCE AND CONVERSION TO FULL MEDIAN STERNOTOMY PERFORMED. THE 290025MM VALVE WAS EXPLANTED AND REPLACE WITH A NON-EDWARDS VALVE. THE AORTA WAS SO FRIABLE THAT A BOVINE PERICARDIUM PATCH WAS USED TO ASSIST IN CLOSING IT. ON COMING OFF CPB A RV DYSFUNCTION WAS OBSERVED AND AN IABP WAS PLACED. TOTAL BYPASS RUN WAS 620 MINUTES AND AORTIC CROSS CLAMP TIME OF 395 MINUTES. POST OPERATIVELY THE PATIENT HAD A DETERIORATING CONDITION. A TRANSESOPHAGEAL ECHOCARDIOGRAM DEMONSTRATED PERICARDIAL CLOT THAT WAS EVACUATED FROM PATIENT´S CHEST ON POD #1. DESPITE INTENSIVE SUPPORT, THE PATIENT HAD PROGRESSIVE FAILURE OF ORGANS AND PASSED AWAY ON POD #2. AS PER THE HOSPITAL CLINICAL SUMMARY, THIS CASE WAS DISCUSSED WITH CORONER AND CONCLUSION WAS: "COMPLEX AND DIFFICULT HIGH-RISK PROCEDURE. PATIENT DETERIORATE DESPITE EXTENSIVE SUPPORT." THERE HAS BEEN NO INDICATION OR ALLEGATION THAT USE OF THE SUBJECT DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT´S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 109861 | SEE H10 | REPLACEMENT HEART VALVE | DYE | EDWARDS LIFESCIENCES | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Death| H| R |