FDA Adverse Event
Injury
Summary report: N
MITROFLOW AORTIC PERICARDIAL HEART VALVE
MDR report key: 4061714
·
Received September 4, 2014
Report
- Report Number
- 3004478276-2014-00035
- Event Type
- Injury
- Date Received
- September 4, 2014
- Date of Event
- May 22, 2014
- Report Date
- September 8, 2014
- Manufacturer
- SORIN GROUP CANADA
- Product Code
- DYE
- PMA / PMN Number
- P060038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
THE PATHOLOGY ANALYSIS ON THE VALVE IS STILL ONGOING. NO FINAL EVALUATION CAN BE DRAWN.
Description of Event or Problem · 1
THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2014 THAT A MITROFLOW VALVE MODEL LXA SIZE 23 WAS EXPLANTED IN JUVENILE PATIENT AFTER 1.5 YEARS DUE TO A SEVERE AORTIC STENOSIS. IT WAS ALSO NOTIFIED THAT DURING THE SAME SURGERY ANOTHER MITROFLOW VALVE MODEL LXA SIZE 23 IMPLANTED IN THE PULMONARY POSITION WAS EXPLANTED DUE TO REGURGITATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 542620 | MITROFLOW AORTIC PERICARDIAL HEART VALVE | TISSUE, HEART VALVE | DYE | SORIN GROUP CANADA | LXA | ||
| 542621 | MITROFLOW AORTIC PERICARDIAL HEART VALVE | TISSUE, HEART VALVE | DYE | SORIN GROUP CANADA | LXA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Male | Required Intervention| H |