FDA Adverse Event
Death
Summary report: N
OMNICARBON (R) CARDIAC VALVE
MDR report key: 580700
·
Received March 10, 2005
Report
- Report Number
- 2124529-2005-00001
- Event Type
- Death
- Date Received
- March 10, 2005
- Date of Event
- March 4, 2005
- Report Date
- March 10, 2005
- Manufacturer
- MEDICALCV, INC.
- Product Code
- LWQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AS REPORTED TO MANUFACTURER ON THE MORNING IN 2005: PT WHO HAD AN OMNICARBON (R) MITRAL MECHANICAL HEART VALVE IMPLANTED IN 2003 WAS PRESENTED WITH PULMONARY EDEMA, UPON EVALUATION UNABLE TO VISUALIZE THE IMPLANTED VALVES LEAFLET. PT UNDERWENT EMERGENCY VALVE REPLACEMENT SURGERY. IT WAS REPORTED THAT THE MISSING LEAFLET COULD NOT BE LOCATED. AFTERNOON SAME DAY DR. PERFORMING EXPLANT/REIMPLANT SURGERY CONTACTED BY MANUFACTURER TO DETERMINE STATUS OF PT AND EFFORTS TO LOCATE ESCAPED LEAFLET. MFR NOTIFIED THAT PT WAS IN ICU IN CRITICAL CONDITION AND THAT LEAFLET WAS NOT LOCATED. FIVE DAYS LATER MANUFACTURER BECAME AWARE THAT THE PT HAD EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNICARBON (R) CARDIAC VALVE | MECHANICAL HEART VALVE | LWQ | MEDICALCV, INC. | 3523 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Death |