FDA Adverse Event
Death
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2040827
·
Received March 30, 2011
Report
- Report Number
- 9612164-2011-00128
- Event Type
- Death
- Date Received
- March 30, 2011
- Date of Event
- February 26, 2011
- Report Date
- March 6, 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
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: CVA/STROKE.
Description of Event or Problem · 1
PT RECEIVED A 3.0MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE MID CX AND A 3.0MM DIAMETER X 30MM LENGTH ENDEAVOR SPRINT RX STENT IN THE MID LAD DURING INDEX PROCEDURE WITH NO ISSUE REPORTED; HOWEVER IT WAS REPORTED THAT 1 DAY POST IMPLANT OF THE ENDEAVOR SPRINT RX STENTS, THE PT SUFFERED A CVA EVENT. PROLONGED HOSPITALIZATION AND MEDICAL INTERVENTION WERE REQUIRED. INVESTIGATOR REPORTED THAT THE CVA EVENT WAS NOT RELATED TO THE STUDY STENT, BUT WAS PROBABLY RELATED TO THE PROCEDURE. IT IS REPORTED THAT THE PT DIED 2 WEEKS POST IMPLANT OF THE ENDEAVOR SPRINT RX STENTS. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS HEMORRHAGIC STROKE. (MFR # 9612164-2011-00129).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0001060403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death| R | ASA| CLOPIDOGREL| ANGLIOTENSIN II RECEPTOR ANTAGONIST| CA++ ANTAGONIST| DIURETIC| LIPID LOWERING DRUG |