MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS29A manufactured by Edwards Lifesciences.
[141333528]
Per the instructions for use (ifu), mechanical failure of the delivery system, and/or accessories potential risk of the tmvr procedure. The delivery system was discarded following the procedure and was not available for evaluation. Transcatheter delivery balloon burst complaints have been previously investigated by edwards and documented in a clinical technical summary written by edwards lifesciences. A detailed root cause analysis revealed that it is very unlikely that a product defect contributes to this type of event. There are extensive manufacturing inspections in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing performed to every manufactured lot). The thv delivery system balloons are subject to increased risk of burst due to contact with a highly calcified annulus. Analysis revealed that these types of ruptures are typically caused by puncture from patient calcification when the inflated delivery system balloon comes in contact with the calcification at full inflation/deployment. In addition, the balloon burst increases the possibility of an obstacle (i. E. Patient's anatomy or sheath tip) interfering with retraction of the balloon/balloon material. The physician training manual provides the following instruction: if the inflation balloon leaks or bursts, do not use excessive force when removing the balloon. In this case, although the exact cause of the event cannot be confirmed, procedural factors (5cc of additional volume in the balloon, valve in valve procedure), in addition to patient factors (pre-existing stenotic surgical mitral valve) may have contributed to the balloon burst during the deployment of the sapien 3 valve in a pre-existing surgical mitral valve. The ruptured balloon likely contributed to the reported difficulties encountered during the withdrawal of the delivery system. 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
[141333529]
As reported, during a transeptal mitral valve-in-valve procedure (sapien 3 in a stenotic medtronic mosaic valve), balloon valvuloplasty was performed prior to the 29mm sapien 3 valve deployment. During the sapien 3 valve deployment, the commander delivery system balloon ruptured. The valve was deployed with nominal plus 5cc of volume. Post deployment the valve landed in 80:20 atrial/ventricular position with none/trace perivalvular leak (pvl). No injury to the patient was reported. During the removal of the delivery system the access site had to be opened? A little? In order to remove the delivery system. No access site cutdown was performed or required. At the time of the report, the patient was in stable condition and doing well. The cause of the balloon rupture was not determined. The commander delivery system was discarded following the procedure. The valve remains implanted in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01165 |
| MDR Report Key | 8480702 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-04-11 |
| Device Manufacturer Date | 2018-12-10 |
| Date Added to Maude | 2019-04-03 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EDWARDS COMMANDER DELIVERY SYSTEM |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2019-04-03 |
| Model Number | 9600LDS29A |
| Lot Number | 61800895 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2019-04-03 |