ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
Report
- Report Number
- 2953200-2011-00076
- Event Type
- Injury
- Date Received
- January 12, 2011
- Date of Event
- October 6, 2010
- Report Date
- December 13, 2010
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). EVAL RESULTS: (STROKE).
DURING THE INDEX PROCEDURE THE PT HAD 3 ENDEAVOR SPRINT RX DRUG-ELUTING STENTS IMPLANTED IN THE PROXIMAL LCX (REF:MFR2953200-2011-00073, 2953200-2011-00074, 2953200-2011-00075). IT WAS REPORTED THAT AT THE 30 DAY F/U THE PT HAD STABLE ANGINA. APPROX 2 MONTHS POST THE INDEX PROCEDURE THE PT HAD A PTCA TO TREAT A REVASCULARIZATION OF THE PROXIMAL AND MID RCA. THREE MORE ENDEAVOR SPRINT RX DRUG-ELUTING STENTS WERE IMPLANTED (REF: MFR2953200-2011-00077, 2953200-2011-00078). AT THE 6 MONTH F/U THE PT WAS REPORTEDLY FREE OF SYMPTOMS. NO CLINICAL F/U WAS COMPLETED AT THE 1.5 YEAR F/U DUE TO THE PT'S HIGH WORK LOAD. THE PT WAS REPORTEDLY FREE OF SYMPTOMS AT THE 2 YEAR AND 2.5 YEAR F/U. IT WAS HOWEVER, REPORTED THAT THE PT SUFFERED A STROKE APPROX 30 MONTHS POST THE INDEX PROCEDURE AND ANOTHER STROKE 3 DAYS POST THE FIRST STROKE. IT WAS CONFIRMED THAT THE STROKES WERE NOT RELATED TO THE STUDY STENT OR TO THE STUDY PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization | THE PT HAD BEEN TAKING ASA 24 HRS BEFORE THE EVENT| THE PT HAD BEEN TAKING CLOPIDOGREL 24 HRS BEFORE| THE EVENT. |