MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-31 for BIOCOR VALVE B10-31M-00 * manufactured by St. Jude Medical.
[1577242]
St. Jude biocor mitral valve placed. The patient had progressively increasing signs of congestive heart failure eight months later and a trans-thoracic echocardiogram demonstrated limited prosthetic leaflet excursion with a mitral prosthetic gradient of 17 mmhg. A transesophageal echocardiogram confirmed this finding with a mitral prosthetic area calculated at 1. 0-1. 1 cm2. Cardiac catheterization confirmed significant prosthetic mitral stenosis with a mean gradient of 12-13 mmhg and a mitral valve orifice area of 1. 2 cm2, associated with pulmonary hypertension in the high 50s systolic. In this context, reparative mitral valve replacement for early bioprosthetic failure was proposed and no further coronary intervention was felt to be indicated. Manufacturer sent a kit for return of the valve. Unknown who contacted the manufacturer that a concern existed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1655779 |
| MDR Report Key | 1655779 |
| Date Received | 2010-03-31 |
| Date of Report | 2010-03-30 |
| Date of Event | 2010-02-11 |
| Report Date | 2010-03-30 |
| Date Reported to FDA | 2010-03-31 |
| Date Added to Maude | 2010-04-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOCOR VALVE |
| Generic Name | HEART VALVE, NON-ALLOGRAFT TISSUE |
| Product Code | LWR |
| Date Received | 2010-03-31 |
| Returned To Mfg | 2010-03-31 |
| Model Number | B10-31M-00 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 27 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 177 COUNTY ROAD B, EAST ST. PAUL MN 55117998 US 55117 9983 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2010-03-31 |