FDA Adverse Event
Injury
Summary report: N
MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
MDR report key: 3190762
·
Received June 26, 2013
Report
- Report Number
- 2025587-2013-00102
- Event Type
- Injury
- Date Received
- June 26, 2013
- Report Date
- June 5, 2013
- Manufacturer
- HEART VALVES SANTA ANA
- Product Code
- LWR
- PMA / PMN Number
- P990064
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DUE TO THE LACK OF SPECIFIC INFORMATION AVAILABLE AND INABILITY FOR MEDTRONIC TO DETERMINE IF THE OTHER EVENTS WERE ALREADY IN OUR SYSTEM, THIS MEDWATCH WILL BE FILED TO CAPTURE THE NONSPECIFIC EVENT INFORMATION. BASED ON THE LACK OF PRODUCT RETURN AND SERIAL NUMBERS, OUR INVESTIGATION WAS LIMITED AND THE CLINICAL OBSERVATION COULD NOT BE DETERMINED. MEDTRONIC'S QUALITY ASSURANCE TEAM WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION THAT FIVE BIOPROSTHETIC VALVES, UNKNOWN IMPLANT DURATION AND UNKNOWN EVENT DATES, WERE EXPLANTED DUE TO HIGH GRADIENTS, STENOSIS AND FIBRINOUS DEBRIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290926 | MOSAIC AORTIC BIOPROSTHETIC HEART VALVE | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | HEART VALVES SANTA ANA | 305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |