FDA Adverse Event
Injury
Summary report: N
MITROFLOW LXA
MDR report key: 8318823
·
Received February 7, 2019
Report
- Report Number
- 3004478276-2019-00126
- Event Type
- Injury
- Date Received
- February 7, 2019
- Date of Event
- July 30, 2014
- Report Date
- February 7, 2019
- Manufacturer
- LIVANOVA CANADA CORP.
- Product Code
- LWR
- UDI-DI
- 00896208000108
- PMA / PMN Number
- P060038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS CASE IS PART OF CAPA (B)(4) EVENTS IDENTIFIED AS POSSIBLE COMPLAINT RELATED TO VALVE RE-INTERVENTION. NO FURTHER EVENT DETAILS WERE PROVIDED. THIS CASE IS BEING REPORTED TO FDA IN A CONSERVATIVE WAY, AND NO POSSIBLE INVESTIGATION WILL BE PERFORMED AT THIS TIME. DEVICE NOT AVAILABLE FOR RETURN.
Description of Event or Problem · 1
BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT IS RELATED TO A MITROFLOW VALVE LXA21 IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH A MITROFLOW DLA19 ON (B)(6)2014. NO FURTHER EVENT DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110715 | MITROFLOW LXA | TISSUE HEART VALVE | LWR | LIVANOVA CANADA CORP. | LXA21 | 00896208000108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |