EDWARDS INTUITY ELITE VALVE SYSTEM
Report
- Report Number
- 2015691-2023-15007
- Event Type
- Injury
- Date Received
- August 3, 2023
- Date of Event
- December 18, 2022
- Report Date
- September 26, 2023
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- LWR
- PMA / PMN Number
- P150036
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND EDWARDS INTUITY ELITE VALVE SYSTEM MODEL# 8300AB, PMA# P150036. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.
THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THROMBOSIS IS A WELL-RECOGNIZED COMPLICATION OF PROSTHETIC DEVICES. DEVICE THROMBOSIS IS THE FORMATION OF BLOOD CLOTS FORMING ON THE DEVICE/GRAFT. THESE CLOTS COULD SIGNIFICANTLY IMPACT THE FUNCTION OF THE VALVE RESULTING IN HARM. THERE MAY BE CASES OF INCIDENTAL FINDING BY IMAGING (ECHOCARDIOGRAPHY AND/OR CT SCAN) OF SUBCLINICAL LEAFLET THROMBOSIS (HALT) WHERE THE PATIENT WILL BENEFIT FROM A CLOSE FOLLOW-UP AND MAY BE TREATED WITH ORAL ANTICOAGULANT. THE MOST LIKELY CAUSE IS PATIENT FACTORS.
CORRECTED B5.
AS PER FURTHER INFORMATION OBTAINED, UPDATED SECTION B5, B6 AND B7.
EDWARDS RECEIVED NOTIFICATION THAT THIS 69 YEAR OLD FEMALE PATIENT WITH THIS VALVE MODEL 8300A23 IMPLANTED IN AORTIC POSITION EXPERIENCED VALVE THROMBOSIS LEADING TO ISCHEMIC STROKE AFTER AN IMPLANT DURATION OF SEVEN (7) MONTHS AND TWENTY (20) DAYS. AS REPORTED, LEFT ANTERIOR PARTIAL INFARCTION OCCURRED DURING CORONARY ANGIOGRAPHY PERFORMED ONE DAY PRIOR STROKE ONSET.
EDWARDS RECEIVED NOTIFICATION THAT THIS 69 YEAR OLD FEMALE PATIENT WITH THIS VALVE MODEL 8300A23 IMPLANTED IN AORTIC POSITION EXPERIENCED VALVE THROMBOSIS LEADING TO ISCHEMIC STROKE AFTER AN IMPLANT DURATION OF SEVEN (7) MONTHS AND TWENTY (20) DAYS. AS REPORTED, HIGHER GRADE OF RIGHT CORONARY ARTERY STENOSIS WAS OBSERVED ONE DAY BEFORE STROKE ONSET DATE. LEFT ANTERIOR PARTIAL INFARCTION OCCURRED DURING CORONARY ANGIOGRAPHY PERFORMED ONE DAY PRIOR STROKE ONSET. INITIAL RIGHT HEMIPARESIS AND APHASIA WERE REPORTED. REPORTEDLY, THE PATIENT WAS IN CARDIOGENIC SHOCK DUE TO PERICARDIAL TAMPONADE AFTER LYSIS FOR ISCHEMIC INSULT WITH COILING OF A BLEEDING 1ST MARGINAL BRANCH.
EDWARDS RECEIVED INFORMATION THAT THIS 69 YEAR OLD PATIENT WITH A VALVE MODEL 8300A23 EXPERIENCED VALVE THROMBOSIS LEADING TO ISCHEMIC STROKE AFTER AN IMPLANT DURATION OF SEVEN (7) MONTHS AND TWENTY (20) DAYS. AS REPORTED, PATIENT PRESENTED TO HOSPITAL WITH CHEST PAIN AND ACUTE CORONARY SYNDROME WAS CONFIRMED. CORONARY ANGIOGRAPHY WAS PERFORMED, CORONARY ARTERY DISEASE WITH HIGH GRADE OSTIAL RCA STENOSIS WAS CONFIRMED. DURING THE INTERVENTION, RIGHT HEMIPARESIS AND APHASIA OCCURRED. CMRI SHOWED (HYPER)ACUTE ANTERIOR PARTIAL INFARCT OF THE LEFT HIGH FRONTAL CORTICAL AREA. LYSIS THERAPY WAS STARTED WHICH THEN LED TO A SPONTANEOUS PERFORATION OF A THIN 1ST MARGINAL BRANCH, WHICH RESOLVED WITH 3 COILS. THE PATIENT WAS DISCHARGED AND IS CURRENTLY HEMIPLEGIC AND WHEEL-CHAIR BOUND. PER THE SITE, VALVE THROMBOSIS COULD NOT BE CONFIRMED BUT HAS NOT BEEN RULED OUT EITHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 285419 | EDWARDS INTUITY ELITE VALVE SYSTEM | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | EDWARDS LIFESCIENCES | 8300AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Life Threatening| O |