FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2100438
·
Received May 17, 2011
Report
- Report Number
- 9612164-2011-00438
- Event Type
- Injury
- Date Received
- May 17, 2011
- Date of Event
- March 28, 2011
- Report Date
- April 19, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL, RESULTS: (CVA/STROKE).
Description of Event or Problem · 1
PT RECEIVED A 2.75MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE MID LAD. STENT IMPLANT WAS SUCCESSFUL. HOWEVER, IT WAS REPORTED THAT APPROX 7 MONTHS POST INDEX PROCEDURE THE PT WAS RE-HOSPITALIZED DUE TO AN ISCHEMIC STROKE. CEREBRAL ANGIO SHOWED A STENOTIC LESION (95%) IN THE INTERNAL CAROTID. BILATERAL KIDNEY LESION WAS ALSO CONFIRMED. INVESTIGATOR REPORTED THAT THE EVENT WAS UNRELATED TO THE STUDY STENT AND PROCEDURE. THE PT IS REPORTED TO BE RECOVERED. NO OTHER CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0000892457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization | BETA| CLOPIDOGREL| ASA| DIGOXIN| LIPID LOWERING DRUG| DIURETIC| ACE |