FDA Adverse Event
Death
Summary report: N
ENDEAVOR RX CORONARY STENT SYSTEM
MDR report key: 1712896
·
Received June 4, 2010
Report
- Report Number
- 2953200-2010-01044
- Event Type
- Death
- Date Received
- June 4, 2010
- Date of Event
- November 29, 2009
- Report Date
- May 7, 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
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4). RESULTS: MYOCARDIAL INFARCTION.
Description of Event or Problem · 1
EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH AN MI. FOUR ENDEAVOR RAPID EXCHANGE (RX) DRUG-ELUTING STENTS WERE IMPLANTED ONE IN THE DISTAL LAD, ONE IN THE DISTAL LCX, ONE IN THE PROXIMAL RCA AND ONE IN THE MID RCA. (REF MFR# 2953200-2010-01043, 2953200-2010-01045, 2953200-2010-01046). 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 IMPLANTED STENT. NO FURTHER DETAILS ARE AVAILABLE. AT 1 MONTH, 6 MONTH, 1 YEAR AND 1.5 YEAR FOLLOW-UPS PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS. IT WAS REPORTED THAT THE PT EXPIRED 21.5 MONTHS POST INDEX PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | 0000411962 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Death | ASA| CLOPIDOGREL| 24 HOURS BEFORE EVENT |