FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2230619
·
Received August 11, 2011
Report
- Report Number
- 9612164-2011-00920
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- June 19, 2011
- Report Date
- July 19, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: (MYOCARDIAL INFARCTION).
Description of Event or Problem · 1
DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED TO THE MID LAD AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE MID LEFT CIRCUMFLEX. THE FOLLOWING DAY THE PATIENT SUFFERED A MYOCARDIAL INFARCTION (MI). THE MI WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS DEFINITELY RELATED TO THE STUDY STENT. (REF MFR # 9612164201100919).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0005534967 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | AND ASA AT TIME OF REPORTED EVENT| ACE| THE PATIENT WAS TAKING BETA-BLOCKERS| LIPID LOWERING DRUGS| CLOPIDOGREL |