FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2172675
·
Received July 20, 2011
Report
- Report Number
- 9612164-2011-00797
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- June 22, 2011
- Report Date
- March 5, 2012
- Manufacturer
- MEDTRONIC IRELAND
- 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: (MYOCARDIAL INFARCTION).
Additional Manufacturer Narrative · 1
CORRECTION TO EVENT DATE - DATE OF EVENT HAS BEEN CONFIRMED AS (B)(6) 2011 AND NOT (B)(6) 2011 AS PREVIOUSLY REPORTED.
Description of Event or Problem · 1
DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL LAD AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE MID LAD. A LATERAL BRANCH OCCLUSION OCCURRED DURING PROXIMAL LAD IMPLANTATION. ON THE SAME DAY THE PATIENT SUFFERED A MYOCARDIAL INFARCTION (MI). THE MI WAS NOT RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE. (REF MFR #9612164-2011-00796).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0003134629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization | LIPID LOWERING DRUGS| THE PATIENT WAS TAKING BETA-BLOCKERS,| DIURETIC,| ACE INHIBITOR,| ASA AT TIME OF EVENT.| CLOPIDOGREL AND| NITRATE, |