MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE 9600TFX29A manufactured by Edwards Lifesciences.
[185515510]
Udi number: (b)(4). Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803. 56 when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[185515511]
As reported by the edwards implant patient registry, as found during an on-line obituary search, a mitral valve replacement (mvr) patient expired from unknown causes 19 days post implant of a 26mm sapien 3 valve in the native mitral position. Medical record review revealed during an off-label mvr procedure, a sapien 3 valve was implanted in the native mitral valve via an open sternotomy. A planned cabg procedure, with the right open saphenous vein harvest, was also performed. Post mvr, the patient became? Severely? Hypotensive. Echo indicated? A fair amount? Of clots around the right atrium. Tee indicated the sapien 3 valve was functioning properly. On postoperative day (pod) 1, the patient was returned to surgery. Active bleeding from one of the branches from the vein graft was observed. Extensive cleaning of the pericardial cavity was performed. The patient stabilized and was returned to the cticu. The sapien 3 valve remained implanted in the patient. No further information regarding the sapien 3 explant and the patient death is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2020-11220 |
| MDR Report Key | 9897359 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-12-07 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-06-02 |
| Date Added to Maude | 2020-03-30 |
| 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. RENEE VAN DORNE |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492506385 |
| 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 | 3 |
| Brand Name | EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE |
| Generic Name | PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED |
| Product Code | NPU |
| Date Received | 2020-03-30 |
| Model Number | 9600TFX29A |
| 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. Death; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-30 |