MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for EDWARDS INTUITY ELITE VALVE SYSTEM 8300AB manufactured by Edwards Lifesciences.
[188405268]
The device was returned to edwards for evaluation. Evaluation is in progress. The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution. No issues were identified that would have impacted this event. Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus. While the majority of affected patients are asymptomatic, it can lead to significant morbidity including heart failure and hemolytic anemia. Pvl can occur in the mitral and aortic position for similar reasons, including technique and patient related factors. The type and cause of regurgitation varies depending upon multiple factors. Typically, mild regurgitation is not unusual after initial valve replacement, and is usually tolerated by patients. Often moderate to high regurgitation requiring re-operation in the immediate post-operation period is due to procedural related issues and is unrelated to the device. Regurgitation which develops progressively over time can be due to number of issues including patient related factors or structural valve deterioration. A manufacturing issue was not identified. A definitive root cause could not be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event. Edwards lifesciences will continue to monitor all reported events. No further actions are required at this time.
Patient Sequence No: 1, Text Type: N, H10
[188405269]
Edwards received information that a 21mm aortic valve, implanted approximately one (1) year, was explanted due to paravalvular leak. The device was originally implanted for aortic valve replacement to correct aortic stenosis. After implant, mild paravalvular leak was detected. The patient had been monitored, but the condition has not been improved. The device was explanted and replaced with a 23mm aortic valve with no adverse patient events reported. Upon the valve explant, paravalvular leak from the area between corresponds to the right-coronary cusp and the non-coronary cusp was detected. The surgeon commented that the encroachment of host tissue on that area was insufficient and thin. The patient status was reported as? Under treatment.? There was no allegation of device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-11238 |
| MDR Report Key | 9903631 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS AMRITHA SRINIVASAN |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDWARDS INTUITY ELITE VALVE SYSTEM |
| Generic Name | TISSUE, HEART-VALVE |
| Product Code | LWR |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-12 |
| Model Number | 8300AB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | 1 EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |