FDA Adverse Event
Death
Summary report: N
PRECISE SDS SELF EXPANDING
MDR report key: 1289371
·
Received January 14, 2009
Report
- Report Number
- 9616099-2009-00048
- Event Type
- Death
- Date Received
- January 14, 2009
- Date of Event
- July 27, 2008
- Report Date
- December 19, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- FGE
- PMA / PMN Number
- K012993
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
AS PER THE DATABASE: THE PATIENT DIED APPROXIMATELY ONE MONTH POST PROCEDURE. THE CAUSE OF DEATH WAS REPORTED AS OTHER. SITE INDICATED THAT THE PATIENT DIED IN NURSING HOME. PATIENT HAD BEEN NON-COMPLIANT WITH POST PROCEDURE MEDICATIONS. THE EXACT CAUSE OF DEATH IS UNKNOWN AT THIS TIME. THE EVENT WAS GRADED AS UNRELATED TO THE IMPLANTED PRECISE STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISE SDS SELF EXPANDING | SELF EXPANDING STENTS (FGE) | FGE | CORDIS DE MEXICO | NA | 13209347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death |