FDA Adverse Event
Death
Summary report: N
ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM
MDR report key: 2211873
·
Received August 8, 2011
Report
- Report Number
- 9612164-2011-00892
- Event Type
- Death
- Date Received
- August 8, 2011
- Date of Event
- April 20, 2011
- Report Date
- May 6, 2012
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Additional Manufacturer Narrative · 1
(B)(4). EVAL, RESULTS: (MI, DEATH).
Description of Event or Problem · 1
IT WAS ASSESSED THAT THE TARGET LESION WAS NOT INVOLVED IN THE MI EVENT.
Description of Event or Problem · 1
CAUSE OF DEATH REPORTED AS CARDIOPULMONARY ARREST.
Description of Event or Problem · 1
AN ENDEAVOR SPRINT OVER THE WIRE (OTW) DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD DURING INDEX PROCEDURE. IT IS REPORTED THAT THE PT EXPIRED APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT IT WAS A CARDIAC DEATH. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS ASSOCIATED WITH MI AND WAS NOT RELATED TO THE STUDY STENT OR THE STUDY PROCEDURE. IT WAS REPORTED THAT THERE WAS NO EVIDENCE OF STENT THROMBOSIS. AUTOPSY REPORT IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death |