FDA Adverse Event
Death
Summary report: N
ENDEAVOR RX
MDR report key: 1051290
·
Received May 21, 2008
Report
- Report Number
- 2953200-2008-00335
- Event Type
- Death
- Date Received
- May 21, 2008
- Date of Event
- July 9, 2007
- Report Date
- April 21, 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
- NO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS, CONCLUSION: OTHER (LACK OF INFO).
Description of Event or Problem · 1
THE PT HAD STABLE ANGINA AT TIME OF PROCEDURE. THERE WERE TWO LESIONS TREATED APPROX 19 MONTHS AGO. ONE ENDEAVOR STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LAD (3.5X15MM) (REF:MDR2953200-2008-00336) AND ONE ENDEAVOR STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL LAD (3.5 X 18MM). IT WAS REPORTED THE PT WAS SEEN AT 30 DAYS AND 6 MONTHS POST STENT IMPLANT FOLLOW UP, PT WAS ASYMPTOMATIC. PT SUFFERED A SUDDEN DEATH 10 MONTHS POST STENT IMPLANT. AUTOPSY REPORT IS NOT AVAILABLE. THE INVESTIGATOR HAS INDICATED THAT DEATH WAS NOT RELATED TO THE ENDEAVOR STENT. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR RX | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death | ASPIRIN = 75MG| CLOPIDOGREL = 75MG |