FDA Adverse Event
Injury
Summary report: N
MITROFLOW AORTIC PERICARDIAL HEART VALVE
MDR report key: 5730263
·
Received June 16, 2016
Report
- Report Number
- 3004478276-2016-00060
- Event Type
- Injury
- Date Received
- June 16, 2016
- Date of Event
- May 24, 2016
- Report Date
- May 20, 2016
- Manufacturer
- LIVANOVA CANADA CORP.
- Product Code
- DYE
- UDI-DI
- 00896208000108
- PMA / PMN Number
- P060038/S002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO INFORMATION SINCE DEVICE IS IN THE PROCESS TO BE RETURNED. DEVICE WILL BE EVALUATED AFTER RETURN TO MANUFACTURER.
Description of Event or Problem · 1
THE MANUFACTURER WAS INFORMED ON (B)(6) 2016 THAT SURGEON IS GOING TO PERFORM A RE-OPERATION ON A PATIENT AGED OF (B)(6) WHO HAD A MITROFLOW LXA 21 IMPLANTED IN (B)(6) 2011. MANUFACTURER RECEIVED INFORMATION ON (B)(6) 2016 THAT RE-OPERATION WAS PERFORMED ON (B)(6) 2016 AND MITROFLOW LXA 21 WAS REPLACED WITH MECHANICAL VALVE SIZE 21.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 384348 | MITROFLOW AORTIC PERICARDIAL HEART VALVE | TISSUE HEART VALVE | DYE | LIVANOVA CANADA CORP. | LXA | 00896208000108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |