MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX29 manufactured by Edwards Lifesciences.
[127059324]
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). Deployment of the sapien 3 valve in a previously implanted mitral surgical ring is not indicated per the labeling; therefore the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario. Per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter mitral valve replacement (tmvr) procedure. Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site. Some pvl is not uncommon post deployment. Many cases are mild to moderate, and either resolve over time or do not cause symptoms. Others may be more clinically significant and require intervention. The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the failed mitral bioprosthesis, uneven distribution of calcium, bulky or severe calcification, and valve under-sizing. In this case, the device is not available for evaluation as it remains implanted in the patient. However, there was no allegation or indication a device malfunction contributed to this adverse event. Per the report, the cause of the pvl was the implant of the sapien 3 valve in a d-shaped ring. 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
[127059325]
As reported by our affiliates in (b)(4), a 29mm sapien 3 valve was implanted inside of a pre-existing 34mm physio ring in the mitral position via transapical approach. Post valve implant there was mild to moderate paravalvular leak (pvl) that appeared to be outside the ring itself, there was no leak between the sapien 3 valve and physio ring. The leak was due to the d-shaped surgical ring dehiscence from the native tissue when it was forced into a circle shape by the sapien 3 valve implant; the surgical ring? S sutures pulled away from the tissue. A second 29mm sapien 3 valve was implanted within the first, which was considered to be partially successful and leak was reduced to mild. The patient? S status will be followed during recovery. No further treatment has been planned or performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04674 |
| MDR Report Key | 8067400 |
| Date Received | 2018-11-13 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-10-19 |
| Device Manufacturer Date | 2018-04-06 |
| Date Added to Maude | 2018-11-13 |
| 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 | 0 |
| Brand Name | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2018-11-13 |
| 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 | 2018-11-13 |