FDA Adverse Event
Death
Summary report: N
MITROFLOW LXA
MDR report key: 8834868
·
Received July 29, 2019
Report
- Report Number
- 1718850-2019-01045
- Event Type
- Death
- Date Received
- July 29, 2019
- Date of Event
- March 29, 2017
- Report Date
- July 3, 2019
- Manufacturer
- LIVANOVA CANADA CORP.
- Product Code
- LWR
- UDI-DI
- 00896208000092
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A PATIENT WAS IMPLANTED WITH A MITROFLOW LX19 (SN (B)(4)) ON (B)(6) 2013. THE PATIENT DEATH WAS REPORTED TO BE RELATED TO THE PREMATURE FAILURE OF THE MITROFLOW VALVE. MEDICAL RECORDS REPORTED FROM (B)(6) MEDICAL CENTER REPORTED THAT THE VALVE FAILURE WAS DUE SEVERE VALVE CALCIFICATION AND LEAFLETS FIXED. ON (B)(6) 2017 TOE REPORTED THAT ¿ THE AORTIC VALVE LEAFLETS ARE SEVERELY THICKENED WITH REDUCED SYSTOLIC EXCURSION. SEVERE AORTIC CALCIFICATION IS VISUALIZED. MEAN GRADIENT WAS REPORTED TO BE 97MMHG."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 629831 | MITROFLOW LXA | TISSUE HEART VALVE | LWR | LIVANOVA CANADA CORP. | LXA19 | 00896208000092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death| H |