FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 1850905
·
Received September 29, 2010
Report
- Report Number
- 2953200-2010-01850
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- August 25, 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
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION RESULTS: MI.
Description of Event or Problem · 1
A 2.5MM DIAMETER X 12MM LENGTH AND A 4.0MM DIAMETER X 9MM LENGTH (MFR # 2953200-2010-01851), ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING CORONARY STENT WERE DEPLOYED IN THE DISTAL RCA AND LM OF A PT. STENT DEPLOYMENT WAS SUCCESSFUL; HOWEVER, IT WAS REPORTED THAT DURING PROCEDURE, THE PT SUFFERED AN MI. THE PT IS REPORTED TO BE RECOVERED AND 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 CARDIOVASCULAR GALWAY | NA | 0000899511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization |