FDA Adverse Event
Death
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 1711707
·
Received June 3, 2010
Report
- Report Number
- 2953200-2010-01012
- Event Type
- Death
- Date Received
- June 3, 2010
- Date of Event
- October 12, 2013
- Report Date
- January 27, 2014
- 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)
Additional Manufacturer Narrative · 1
(B) (4). RESULTS: MI.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT SUFFERED CARDIOPULMONARY ARREST APPROX 58 MONTHS POST INDEX PROCEDURE AND EXPIRED. IT HAS NOT BEEN ASSESSED IF THE DEATH WAS RELATED TO THE STUDY DEVICE.
Description of Event or Problem · 1
EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH AN MI. PATIENT HAD ONE LESION TREATED DURING INDEX PROCEDURE. TWO ENDEAVOR SPRINT RX DRUG-ELUTING STENTS WERE IMPLANTED (OVERLAPPING) TO MID LCX (REF MFR# 2953200-2010-01011). 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | 0000810236 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Death| H | CLOPIDOGREL AND ASPIRIN. |