FDA Adverse Event
Death
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 1990328
·
Received February 9, 2011
Report
- Report Number
- 2953200-2011-00316
- Event Type
- Death
- Date Received
- February 9, 2011
- Date of Event
- September 11, 2010
- Report Date
- January 10, 2011
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION, RESULTS: MI, DEATH.
Description of Event or Problem · 1
TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED, ONE IN THE MID LAD AND ONE IN THE MID RCA. PATIENT'S CURRENT CARDIAC STATUS AT 30 DAY FOLLOW UP WAS STABLE ANGINA. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 6 MONTH AND 1 YEAR FOLLOW UPS. PATIENT'S CURRENT CARDIAC STATUS AT 1.5 YEAR FOLLOW UP WAS STABLE ANGINA. PATIENT WAS ASYMPTOMATIC/FREE OF SYMPTOMS AT 2 YEAR FOLLOW UP. IT IS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY 28 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT'S DEATH WAS ASSOCIATED WITH AN MI. (REF MFR # 2953200-2011-00317).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death | PATIENT WAS TAKING ASPIRIN 24 HOURS BEFORE EVENT. |