FDA Adverse Event
Injury
Summary report: N
MITROFLOW AORTIC PERICARDIAL HEART VALVE
MDR report key: 4439406
·
Received January 21, 2015
Report
- Report Number
- 3004478276-2014-00079
- Event Type
- Injury
- Date Received
- January 21, 2015
- Date of Event
- December 17, 2014
- Report Date
- January 21, 2015
- Manufacturer
- SORIN GROUP CANADA INC.
- Product Code
- DYE
- PMA / PMN Number
- P060038/S002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: SINCE THE DEVICE WAS NOT RETURNED AND NO INFORMATION WAS PROVIDED NO INVESTIGATION WAS PERFORMED.
Additional Manufacturer Narrative · 1
RESULTS: REVIEW OF THE DEVICE HISTORY RECORD WILL BE CONDUCTED UPON IDENTIFICATION OF THE VALVE SERIAL #. THE FULL HISTOPATHOLOGICAL EVALUATION WILL BE PERFORMED, IF THE EXPLANTED VALVE IS RETURNED.
Description of Event or Problem · 1
THE MANUFACTURER WAS NOTIFIED ON 22 DECEMBER 2014 THAT MITROFLOW VALVE (MODEL LXA, SIZE AND SERIAL # - UNKNOWN) WAS EXPLANTED ON (B)(6) 2014. NO OTHER INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT MITROFLOW VALVE (MODEL LXA, SIZE AND SERIAL # - UNKNOWN) WAS EXPLANTED ON (B)(6) 2014.. NO OTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50187 | MITROFLOW AORTIC PERICARDIAL HEART VALVE | TISSUE HEART VALVE | DYE | SORIN GROUP CANADA INC. | LXA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |