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 2018-11-02 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX29 manufactured by Edwards Lifesciences.
[126011296]
This is one of two manufacturer reports being submitted for this case. This report represents the valve implanted in the native mitral position. Please reference related manufacturer report no: 2015691-2017-01142 in (b)(6), the edwards sapien 3 thv, commander delivery system and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i. E. , predicted risk of surgical mortality = 3% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator). In the us, the edwards sapien 3 transcatheter heart valve is 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). Lvot obstruction in patients who undergo transcatheter mitral valve replacement is a well-recognized postoperative complication. In most cases of postoperative lvot obstruction, the obstruction results from the protrusion of the valve into the lvot or from abnormal subvalvular positioning of the prosthesis. Additionally, lvot obstruction may occur postoperatively if there is a narrowed mitral-aortic angle, or due to a thickened interventricular septum. Other possible causes include a hyper contractile left ventricle or atrial fibrillation. Obstruction of the left ventricular outflow tract can also be caused by patient factors (anterior mitral leaflet protruding into the lvot) 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. The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations. Physicians are extensively trained by edwards before they are qualified to use the sapien 3 thv. Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures. The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device. Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment. In this case, the device is not available for evaluation as it remains implanted in the patient. There was no allegation or indication a device malfunction contributed to this adverse event. Per the authors, the patient had a predicted high probability of lvot obstruction based on the pre-procedural cardiac ct, which predicted neo-lvot after tmvr. In addition, the authors explained the risk of lvot obstruction is generally higher in patients with combined aortic and mitral stenosis given the hypertrophied left ventricle and smaller cavity size. 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.
Patient Sequence No: 1, Text Type: N, H10
[126011297]
As reported from the united arab emirates, per the article? Alcohol septal ablation for outflow tract obstruction after transcatheter aortic and mitral valve replacement? , a patient underwent transcatheter double valve implantation (valve in valve aortic and native mitral) using a single transapical access. A 29mm sapien 3 valve was deployed the mitral valve annulus and transesophageal echocardiography revealed a well seated transcatheter valve in the mitral position with a mean gradient of 6 mmhg and no significant paravalvular regurgitation. However, repeat simultaneous left ventricular and aortic pressure measurement showed a significant increase in the left ventricular outflow tract (lvot) gradient and dynamic obstruction with peak-to-peak measurement of 80 mmhg. The patient tolerated the lvot obstruction and remained hemodynamically stable allowing time for treatment. The left ventricular apex was closed without complications. Alcohol septal ablation of the territory supplied by the first septal perforator was performed with immediate marked decrease in the lvot gradient to less than 20mm hg. The patient was extubated a few hours after the intervention and then transitioned to a telemetry floor the next day. The mitral annulus area was measured at 522 mm2. Patient had severe calcification of the posterior mitral annulus involving the left ventricular wall. The patient had a predicted high probability of lvot obstruction based on the pre-procedural cardiac ct, which predicted neo-lvot after tmvr. Reference: edris, ahmad, et al. "alcohol septal ablation for outflow tract obstruction after transcatheter aortic and mitral valve replacement. " catheterization and cardiovascular interventions (2018).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04524 |
| MDR Report Key | 8034034 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-02 |
| Date of Report | 2018-10-10 |
| Date of Event | 2017-04-09 |
| Date Mfgr Received | 2018-10-10 |
| Date Added to Maude | 2018-11-02 |
| 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 | 1 EDWARDS WAY 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 |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2018-11-02 |
| 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. Required No Informationntervention | 2018-11-02 |