FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2100447
·
Received May 17, 2011
Report
- Report Number
- 9612164-2011-00433
- Event Type
- Injury
- Date Received
- May 17, 2011
- Date of Event
- March 18, 2008
- Report Date
- April 18, 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). EVAL, RESULTS: (MI).
Description of Event or Problem · 1
TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE IMPLANTED IN THE MID LCX DURING THE INDEX PROCEDURE. EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH AN MI. IT WAS REPORTED THAT AN MI OCCURRED ONE DAY POST STENT IMPLANT. MI WAS CATEGORIZED AS A NON Q WAVE MI, IN THE TERRITORY OF THE TARGET VESSEL. NO FURTHER DETAILS ARE AVAILABLE. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY, 6 MONTH, 1.5 YEAR, 2.5 YEAR AND 3 YEAR FOLLOW UPS. PT'S CURRENT CARDIAC STATUS AT 1 YEAR AND 2 YEAR FOLLOW UPS WAS UNSTABLE ANGINA. (REF MFR # 9612164-2011-00432).
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 | 52 YR | Hospitalization | CLOPIDOGREL| ASPIRIN AND |