MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-16 for ONX MITRAL STANDARD 31/33 ONXM-31/33 manufactured by Cryolife, Inc. ? Austin.
[183564434]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[183564435]
According to returned implant notifications from the user facility, onxm-31/33 sn (b)(4) and onxae-25 sn (b)(4) were implanted in the mitral position in the same patient on the same day. This investigation is relegated to onxae-25 sn (b)(4). The onxm-31/33 was the mitral and placed in the mitral position. The onxae-25 was placed as an aortic valve. Patient is deceased. Cause of death - pleural effusion. No additional information forthcoming.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649833-2020-00003 |
| MDR Report Key | 9836537 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-04 |
| Date Facility Aware | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-16 |
| 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 | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1300 E. ANDERSON LN., BLDG. B |
| Manufacturer City | AUSTIN TX 78752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONX MITRAL STANDARD 31/33 |
| Generic Name | HEART-VALVE, MECHANICAL |
| Product Code | LWQ |
| Date Received | 2020-03-16 |
| Model Number | ONXM-31/33 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? AUSTIN |
| Manufacturer Address | 1300 E. ANDERSON LN., BLDG. B AUSTIN TX 78752 US 78752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-16 |