FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2141061
·
Received June 21, 2011
Report
- Report Number
- 9612164-2011-00620
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- January 5, 2011
- Report Date
- May 31, 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
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4): (MYOCARDIAL INFARCTION).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID CIRCUMFLEX. ON THE SAME DAY, IT IS REPORTED THAT A MYOCARDIAL INFARCTION (MI) OCCURRED. IT IS UNKNOWN WHETHER THE REPORTED EVENT IS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR DID NOT INDICATE WHETHER THE REPORTED EVENT WAS RELATED TO THE STUDY DEVICE/PROCEDURE. PATIENT HAS HAD NO OTHER ADVERSE EVENTS AT 3 MONTH CHECK.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE STENT WAS IMPLANTED BEYOND ITS EXPIRATION DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0000871466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male | Hospitalization | CA ++ ANTAGONIST| CLOPIDOGREL| LIPID LOWERING DRUG| LIPID LOWERING DRUG| CA ++ ANTAGONIST| CLOPIDOGREL |