FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2251312
·
Received September 13, 2011
Report
- Report Number
- 9612164-2011-01141
- Event Type
- Injury
- Date Received
- September 13, 2011
- Date of Event
- August 23, 2011
- Report Date
- August 29, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060023
- 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 PT HAD TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENTS IMPLANTED TO THE PROXIMAL CIRCUMFLEX. ON THE SAME DAY THE PT SUFFERED A MYOCARDIAL INFARCTION (MI). THE MI WAS NOT RELATED TO THE TARGET VESSEL. THE INVESTIGATOR INDICATED THE REPORTED EVENT WAS POSSIBLY TO THE STUDY DEVICE. (REF MFR #9612164-2011-01140).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0005510617 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization | DIURETICS| ACE INHIBITOR| THE PT WAS TAKING BETA-BLOCKERS| ASA AT THE TIME OF EVENT.| CLOPIDOGREL| LIPID LOWERING DRUGS |