FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 1901582
·
Received November 12, 2010
Report
- Report Number
- 2953200-2010-02227
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- October 8, 2010
- Report Date
- October 15, 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). EVAL: RESULTS: (MI).
Description of Event or Problem · 1
A 2.5MM DIAMETER X 30MM LENGTH ENDEAVOR SPRING RAPID EXCHANGE (RX) DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN THE PROX RCA OF A PT. DURING PROCEDURE THE PT ALSO REC'D A 2.75MM DIAMETER X 30MM LENGTH ENDEAVOR SPRINT RX TO TARGET LESION (MFR REP # 2953200-2010-02228). HOWEVER, IT WAS REPORTED THAT THE PT EXPERIENCED AN MI DURING PROCEDURE. PROLONGED HOSPITALIZATION WAS REQUIRED. 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 | 001019761 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Hospitalization | CLOPIDOGREL| ASPIRIN |