MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-10-07 for CRYOLIFE manufactured by .
[2212120]
Pt developed prosthetic endocarditis with a large perivulvar leak and abscessed cavity s/p avr/cab. An aortotomy was performed, where the valve revealed a bioprosthetic valve with small tear in one of the leaflets. Pt expired intraoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2287435 |
| MDR Report Key | 2287435 |
| Report Source | 99 |
| Date Received | 2011-10-07 |
| Date of Report | 2011-04-29 |
| Date of Event | 2011-04-23 |
| Date Facility Aware | 2011-04-24 |
| Report Date | 2011-04-29 |
| Date Reported to FDA | 2011-04-29 |
| Date Reported to Mfgr | 2011-04-29 |
| Date Added to Maude | 2011-10-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOLIFE |
| Generic Name | AORTIC VALVE AND CONDUIT AVOO |
| Product Code | OHA |
| Date Received | 2011-10-07 |
| Lot Number | 1114.010 |
| ID Number | DNR 108121 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-10-07 |