FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 1924215
·
Received December 7, 2010
Report
- Report Number
- 2953200-2010-02453
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- November 10, 2010
- Report Date
- November 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). EVAL: RESULTS: (MI).
Additional Manufacturer Narrative · 1
CLOPIDOGREL AND ASA.
Description of Event or Problem · 1
THE PT REC'D A 3.0MM DIAMETER X 18MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE PROX RCA (REF MFR # 2953200-2010-02452), A 3.0MM DIAMETER X 24MM LENGTH ENDEAVOR SPRINT RX STENT IN THE MID RCA, A 3.5MM DIAMETER X 30MM LENGTH AND A 3.0MM DIAMETER X 12MM LENGTH ENDEAVOR SPRINT RX STENTS IN THE PROX LAD (REF MFR # 2953200-2010-02454 AND MFR # 2953200-2010-02455) DURING INDEX PROCEDURE. IMPLANT OF THE STENTS WAS SUCCESSFUL; HOWEVER, IT WAS REPORTED THAT THE PT HAD AN MI ONE DAY POST IMPLANT. NO OTHER CLINICAL SEQUELAE WERE REPORTED.
Description of Event or Problem · 1
IT IS UNKNOWN WHETHER THE REPORTED MI WAS RELATED TO THE TARGET VESSEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | 0001060403 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | BETA, CA++ ANTAGONIST, LIPID LOWERING DRUGS |