MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-20 for EDWARDS TRANSCATHETER ESHEATH ESHEATH UNKNOWN manufactured by Edwards Lifesciences.
[128022311]
The actual dates of the events are unknown. Per the authors, the first tmvr was performed in 2012; therefore, 01-jan-2012 has been selected as the occurrence date. In this case, the authors did not specify the valve model number and access approach (transeptal or transapical) related to these events. Possible devices used? Edwards retroflex introducer sheath set? Pma k093877, edwards expandable introducer sheath set? Pma p130009, edwards ascendra+ introducer sheath set? Pma p130009, or edwards esheath introducer set? Pma p140031. The edwards sapien and sapien xt transcatheter heart valves are indicated for patients with severe symptomatic calcified native aortic valve stenosis. The edwards sapien 3 transcatheter heart valve is indicated for patients with symptomatic heart disease due to severe native calcific aortic stenosis or failure 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. Per the instructions for use (ifu), access site complications / perforation or dissection of vessels, ventricle, atrium, septum, myocardium or valvular structures that may require intervention are potential complications associated thv procedure. According to the sapien 3 valve ifu, additional precautions for transseptal replacement of a failed mitral valve bioprosthesis include: presence of devices or thrombus or other abnormalities in the caval vein precluding safe transvenous femoral access for transseptal approach; presence of atrial septal occluder device or calcium preventing safe transseptal access. Safety and effectiveness have not been established for patients with access vessels characteristics that would preclude safe placement of 14f or 16f edwards esheath introducer set, such as severe obstructive calcification or severe tortuosity. Per literature review, risk factors for apical laceration and bleeding include friable tissue, fatty apex, chronic steroid use, dilated lv with thinned walls, and hypertension during removal of the sheath. While patient characteristics are important, achieving good hemostatic control of the lv apex is one of the most critical steps in ensuring the success of the transapical procedure, particularly in the elderly with friable tissue. Additional literature review confirms there is a higher incidence of apical bleeding in female patients and patients over 80 years old. This information correlates with review of complaint history, revealing that the majority of apical bleeding complications appear to be related to surgical technique and/or diseased ventricles during the insertion or removal of the sheath. In this case, there is insufficient information to determine the cause of the reported vascular complications. The authors did not specify the nature of the vascular complications or to which of the devices used during the tmvr procedure these events were associated. There was no allegation or indication of a device malfunction. 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. Reference for article: kamioka n, babaliaros v, morse ma, frisoli t, lerakis s, iturbe jm, binongo j, corrigan f, yousef a, gleason p, wells ja 4th, caughron h, dong a, rodriguez e, leshnower b, o'neill w, paone g, eng m, guyton r, block pc, greenbaum a. (2018). Comparison of clinical and echocardiographic outcomes after surgical redo mitral valve replacement and transcatheter mitral valve-in-valve therapy. Jacc cardiovasc interv. Retrieved from: https://www. Ncbi. Nlm. Nih. Gov/pubmed/29929633. This is one of two manufacturer reports being submitted for this case. Please reference related manufacturer report no: 2015691-2018- 04752.
Patient Sequence No: 1, Text Type: N, H10
[128022312]
As reported in an article,? Comparison of clinical echocardiographic outcomes after surgical redo mitral valve replacement and transcatheter mitral valve-in-valve therapy? , a retrospective study was performed to compare clinical outcomes of patients who underwent redo mitral valve replacement at 3 facilities. 121 redo mitral valve replacement patients were identified. All patients had severely degenerated mitral bioprostheses. Sixty-two (62) of these patients underwent transcatheter mitral valve-in-valve replacement (tmvr) with the sapien, sapien xt, or sapien 3 valve from 2012 to august 2017. Echocardiographic parameters were reported according to the guidelines of the american society of echocardiography definition and the mitral valve academic research consortium (mvarc) consensus document. Transseptal tmvr was done in 48 patients; 14 patients had transapical tmvr. The major finding of the study was that there was no difference in mortality at 30 days and at 1 year between the smvr and tmvr patients despite the higher risk of tmvr patients. Echocardiographic findings after tmvr were similar to smvr at 30 days. There was a statistically significant difference in mitral gradient at 1 year, though this is likely not clinically important. Tmvr may be a good alternative to smvr in selected patients. Per the article, 2 vascular complications (1 major and 1 minor) occurred among the tmvr group during the study period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04810 |
| MDR Report Key | 8091274 |
| Date Received | 2018-11-20 |
| Date of Report | 2018-10-31 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-20 |
| 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, RN |
| 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 | 0 |
| Brand Name | EDWARDS TRANSCATHETER ESHEATH |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2018-11-20 |
| Model Number | ESHEATH UNKNOWN |
| Lot Number | UNK |
| 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 | 2018-11-20 |