FDA Adverse Event
Death
Summary report: N
ENDEAVOR RX CORONARY STENT SYSTEM
MDR report key: 1230178
·
Received November 13, 2008
Report
- Report Number
- 2953200-2008-01051
- Event Type
- Death
- Date Received
- November 13, 2008
- Date of Event
- January 15, 2008
- Report Date
- October 15, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION CODES, RESULTS: (DEATH).
Description of Event or Problem · 1
AN ENDEAVOR DRUG ELUTING STENT WAS IMPLANTED. STENT IMPLANTATION DETAILS ARE UNKNOWN. PATIENT WAS ASYMPTOMATIC AT 30 DAY FOLLOW UP. A NON-SUDDEN, CARDIAC DEATH IS REPORTED TO HAVE OCCURRED THREE MONTHS POST INITIAL STENT IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |