FDA Adverse Event
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2112480
·
Received March 31, 2011
Report
- Report Number
- 9612164-2011-00121
- Date Received
- March 31, 2011
- Date of Event
- February 9, 2011
- Report Date
- March 4, 2011
- Manufacturer
- MEDTRONIC IRELAND
- 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
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DUE TO STABLE ANGINA, THE PT UNDERWENT THE INDEX PROCEDURE WITH SUCCESSFUL DEPLOYMENT OF TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS TO THE PROXIMAL CIRCUMFLEX. APPROX 3 MONTHS POST INDEX PROCEDURE THE PT EXPERIENCED A MYOCARDIAL INFARCTION (MI). THE PT WAS INTUBATED AND RECEIVED AN INTRA-AORTIC BALLOON PUMP (IABP). NO FURTHER DETAILS WERE PROVIDED. IN THE INVESTIGATOR'S OPINION, THE EVENT OF MYOCARDIAL INFARCTION WAS CONSIDERED SEVERE IN INTENSITY AND NOT RELATED TO STUDY MEDICATION, STUDY DEVICE OR STUDY PROCEDURE. (REF MFR # 9612164201100122).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | ASPIRIN| CLOPIDOGREL |