MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-09 for PROPLEGE CORONARY SINUS CATHETER MODEL PR9 manufactured by Edwards Lifesciences.
[188464226]
Article "improved patient recovery with minimally invasive aortic valve surgery: a propensity-matched study" in innovations 00(0)1-9 doi: 10. 1177/1556984519868715. Vascular perforations may occur with the use of several of our devices. A perforation is typically the result of excessive force combined with challenging anatomy and not a malfunction of the device. In this case attempts to retrieve additional information and the device is in process. If additional information is received a supplemental mdr will submitted. The device has not been returned to edwards for evaluation. The device history record (dhr) review could not be performed as the lot number is unknown. The cause of the event remains indeterminable. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
[188464227]
Through review of medical article "improved patient recovery with minimally invasive aortic valve surgery: a propensity-matched study", the following event was identified as pertaining to an edwards device: during a case of aortic valve replacement performed in upper ministernotomy (miavr) emergency conversion to full sternotomy was required in a patient due to a rupture of the coronary sinus during positioning of a peripheral retrograde cardioplegia device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008500478-2020-00191 |
| MDR Report Key | 9806588 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-13 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-09 |
| 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. AMRITHA SRINIVASAN |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492504062 |
| 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 | 3 |
| Brand Name | PROPLEGE CORONARY SINUS CATHETER MODEL PR9 |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-03-09 |
| Model Number | PR9 |
| Catalog Number | PR9 |
| 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 | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2020-03-09 |