MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-20 for EDWARDS SAPIEN 3? TRANSCATHETER HEART VALVE, 29 MM 9600TFX29 manufactured by Edwards Lifesciences.
[184414022]
The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i. E. , predicted risk of surgical mortality = 8% at 30 days, based on the sts risk score and other clinical co-morbidities unmeasured by the sts risk calculator). Obstruction of the left ventricular outflow tract can be caused by patient factors (anterior mitral leaflet protruding into the lvot, septal bulge) or procedural factors (positioning of the valve frame within the annulus). Depending on the degree of obstruction, cardiac output and hemodynamic stability may be affected. Inaccurate deployment is generally a result of use error or a combination or patient and procedural factors. In some cases lvot obstruction could result in clinically significant hemodynamic compromise that may require explanation of the thv with surgical correction. In this case, there was no allegation or indication a device malfunction contributed to this adverse event. The cause of the lvot obstruction and subsequent hemolysis resulting in the patient death, was due to patient factors (protrusion of the septum in the lvot. ) 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.
Patient Sequence No: 1, Text Type: N, H10
[184414023]
As reported, a 29mm sapien 3 valve was implanted within an edwards annuloplasty ring in the mitral position through transseptal approach. The valve in ring was performed with resulting mild pvl leak however, there was an lvot obstruction caused by a protrusion of the septum in the lvot. An alcohol septal ablation was performed to resolve this issue. The patient did well 24hrs hours post procedure but then developed hemolysis causing multiple organ failure and subsequently passed away.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-11076 |
| MDR Report Key | 9862796 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-07-07 |
| Date Added to Maude | 2020-03-20 |
| 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. FRANCES PRESTON |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492505190 |
| 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 SAPIEN 3? TRANSCATHETER HEART VALVE, 29 MM |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2020-03-20 |
| Model Number | 9600TFX29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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. Death; 2. Required No Informationntervention | 2020-03-20 |