FDA Adverse Event
Injury
Summary report: N
EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
MDR report key: 4193556
·
Received October 22, 2014
Report
- Report Number
- 3001743903-2014-00050
- Event Type
- Injury
- Date Received
- October 22, 2014
- Date of Event
- September 18, 2014
- Report Date
- September 23, 2014
- Manufacturer
- ST. JUDE MEDICAL BRASIL LTDA.
- Product Code
- LWR
- PMA / PMN Number
- PP040021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THIS INVESTIGATION CONCLUDED FIBROUS THICKENING OF CUSPS 2 AND 3, TEAR IN CUSP 1, THIN FIBROUS PANNUS INGROWTH ON CUSP 2, AND TINY NODULAR CALCIFICATION IN CUSP 3. SPECIAL STAINS WERE NEGATIVE FOR ORGANISMS, AND NO ACUTE INFLAMMATION WAS PRESENT. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE CAUSE OF THE FIBRIN, PANNUS, CALCIFICATION, AND CUSPAL TEAR WERE DUE TO AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY REVIEW OF THE VALVE'S DEVICE HISTORY RECORD AND THE ANALYSIS PERFORMED. THE CAUSE OF THE FIBRIN, PANNUS, CALCIFICATION, AND CUSPAL TEAR REMAINS UNKNOWN.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE VALVE WAS EXPLANTED AND A CUSPAL TEAR WAS OBSERVED AT EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673951 | EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM | HEART-VALVE, NON-ALLOGRAFT TISSUE | LWR | ST. JUDE MEDICAL BRASIL LTDA. | E100-27M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization| R |