FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 1911057
·
Received November 24, 2010
Report
- Report Number
- 2953200-2010-02329
- Event Type
- Injury
- Date Received
- November 24, 2010
- Date of Event
- October 10, 2010
- Report Date
- October 26, 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 2.75MM DIAMETER X 12MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING CORONARY STENT WAS DEPLOYED IN THE PROX CLX (MFR# 2953200-2010-02328) AND A 2.5MM DIAMETER X 18MM LENGTH ENDEAVOR SPRINT RX DRUG ELUTING CORONARY STENT WERE DEPLOYED IN THE 1ST OBTUSE MARGINAL WITH NO ISSUE REPORTED. HOWEVER, IT WAS REPORTED THAT THE PT SUFFERED AN MI ONE DAY POST IMPLANT OF THE RELEVANT STENTS. 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 | 0000907644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | CLOPIDOGREL| ORAL HYPOGLYCEMIC AGENTS| NITRATE| BETA BLOCKER| ASA| CA++ ANTAGONIST| ACE INHIBITOR |