FDA Adverse Event
Death
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1070319
·
Received June 27, 2008
Report
- Report Number
- 3003742446-2008-00122
- Event Type
- Death
- Date Received
- June 27, 2008
- Date of Event
- October 12, 2007
- Report Date
- June 6, 2008
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANY ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
THE PT HAD A BARE METAL AND DRUG ELUTING STENTS IMPLANTED IN HIS HEART. THE DRUG ELUTING STENT WAS PLACED IN HIS LEFT ANTERIOR DESCENDING IN 2003 AFTER BEING APPROVED BY THE FDA. THE PT SUFFERED A SUDDEN DEATH IN 2007. THIS INFO WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | A1102356 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |