FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2230853
·
Received August 26, 2011
Report
- Report Number
- 9612164-2011-01018
- Event Type
- Injury
- Date Received
- August 26, 2011
- Date of Event
- April 9, 2011
- Report Date
- January 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). EVAL RESULTS: (MYOCARDIAL INFARCTION).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT A 3RD ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED DURING INDEX PROCEDURE. THE STENT WAS IMPLANTED IN THE PROXIMAL LAD. (REF MFR # 9612164201101017, 9612164201101018 AND 9612164201200105).
Description of Event or Problem · 1
DURING INDEX PROCEDURE THE PT HAD ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED TO THE DISTAL RCA AND ONE ENDEAVOR SPRINT (RX) DRUG-ELUTING STENT IMPLANTED TO THE MID LAD. THE FOLLOWING DAY, THE PT SUFFERED A MYOCARDIAL INFARCTION (MI). THE REPORTED MI IS UNRELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THAT REPORTED MI WAS UNRELATED TO THE STUDY STENT. (REF MFR # 9612164201101017).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0001011424 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization | ANGIOTENSIN II RECEPTOR ANTAGONIST| BETA-BLOCKERS| CLOPIDOGREL| LIPID LOWERING DRUG| ASA| NITRATE |