FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2172661
·
Received July 20, 2011
Report
- Report Number
- 9612164-2011-00792
- Event Type
- Injury
- Date Received
- July 20, 2011
- Date of Event
- June 2, 2011
- Report Date
- June 29, 2011
- 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
DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGED (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID CIRCUMFLEX. THE PATIENT SUFFERED AN MI THE FOLLOWING DAY. THE REPORTED MI WAS RELATED TO THE TARGET VESSEL. ONE WEEK LATER, DURING A STAGED PROCEDURE, THE PATIENT HAD TWO ENDEAVOR SPRINT RX DRUG-ELUTING STENTS IMPLANTED TO THE DISTAL RCA ON THE SAME DAY AN MI OCCURRED. THE REPORTED MI WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT BOTH EVENTS WERE RELATED TO THE STUDY DEVICE. (REF MFR # 9612164-2011-00790 AND 9612164-2011-00791).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0003354674 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization | ACE,| CLOPIDOGREL AND| ASA AT TIME OF EVENTS.| LIPID LOWERING DRUGS,| THE PATIENT WAS TAKING BETA-BLOCKER,| NITRATE, |