MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for EDWARDS COMMANDER DELIVERY SYSTEM 9600LDS26A manufactured by Edwards Lifesciences.
[142665886]
(b)(4). Investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[142665887]
As reported, during a mitral valve in valve procedure (26mm s3 in 25mm surgical valve) via transseptal approach, the commander delivery system balloon burst once it reached full inflation. The valve was deployed as intended with mild to moderate pvl noted post deployment. Upon removal of the delivery system, the balloon was unable to inserted back into the esheath. The delivery system and esheath were then removed as a unit and a second esheath was inserted into the patient. A non ew balloon was used to dilate the valve, which reduced the pvl grade to none-trace. The patient left the room in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01343 |
| MDR Report Key | 8522749 |
| Date Received | 2019-04-17 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-05-16 |
| Device Manufacturer Date | 2018-11-16 |
| Date Added to Maude | 2019-04-17 |
| 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 | RN 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 | ONE 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 COMMANDER DELIVERY SYSTEM |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2019-04-17 |
| Model Number | 9600LDS26A |
| Lot Number | 61757101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-17 |