FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 1983018
·
Received February 7, 2011
Report
- Report Number
- 2953200-2011-00294
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- January 6, 2011
- Report Date
- January 11, 2011
- 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 3.5 MM DIAMETER X 24 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT WAS DEPLOYED IN THE MID RCA OF A PATIENT (REF MFR # 2953200-2011-00293). DURING PROCEDURE, THE PATIENT ALSO RECEIVED ONE 2.25 MM DIAMETER X 30 MM LENGTH ENDEAVOR SPRINT RX IN THE PROX CX. NO ISSUES HAVE BEEN REPORTED DURING STENT DEPLOYMENT; HOWEVER, IT WAS REPORTED THAT THE PATIENT HAD AN MI ONE DAY POST IMPLANT OF THE RELEVANT STENT. IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC ON DISCHARGE 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 | 0001015279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | ASA| CLOPIDOGREL |