FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2172663
·
Received July 20, 2011
Report
- Report Number
- 9612164-2011-00789
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- March 17, 2011
- Report Date
- July 9, 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).
Description of Event or Problem · 1
IT WAS CONFIRMED THAT THE 1ST OBTUSE MARGINAL WAS STENTED DURING THE INDEX PROCEDURE AND NOT THE LCX AS INITIALLY 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 CIRCUMFLEX AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE PROXIMAL LAD. THE PATIENT SUFFERED A MYOCARDIAL INFARCTION (MI) ON THE SAME DAY. THE REPORTED MI WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT THE EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE. PATIENT ASYMPTOMATIC AT 30 DAY AND 3 MONTH FOLLOW-UP. (REF # 9612164201100788).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0001141326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization | ASA AT TIME OF EVENTS.| CLOPIDOGREL AND| THE PATIENT WAS TAKING NITRATE, |