FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2160562
·
Received July 6, 2011
Report
- Report Number
- 9612164-2011-00684
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- June 10, 2011
- Report Date
- March 15, 2012
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) INHERENT RISK OF PROCEDURE (STENT THROMBOSIS).
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: (OCCLUSION AND MYOCARDIAL INFARCTION).
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE, TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENTS WERE IMPLANTED TO THE MID RCA. APPROXIMATELY 8.5 MONTHS POST INDEX PROCEDURE, THE PATIENT WAS RE-HOSPITALIZED, THE PATIENT SUFFERED A MYOCARDIAL INFARCTION (MI) AND CORONARY IN-STENT RESTENOSIS WAS CONFIRMED. THE PATIENT REQUIRED INTERVENTION. CPR WAS PERFORMED. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE. REFERENCE MFR REPORT 9612164-2011-00683.
Description of Event or Problem · 1
(B)(4) ADJUDICATED THAT DEFINITE LATE STENT THROMBOSIS, MEDTRONIC HISTORICAL AND ARC OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0001300587 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | CLOPIDOGREL| ASPIRIN |