FDA Adverse Event
Injury
Summary report: N
RESOLUTE INTEGRITY RX
MDR report key: 4944813
·
Received July 28, 2015
Report
- Report Number
- 9612164-2015-01313
- Event Type
- Injury
- Date Received
- July 28, 2015
- Date of Event
- October 4, 2014
- Report Date
- October 6, 2015
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P110013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT IS A SMOKER WITH A HISTORY OF PREVIOUS PAD. INDEX PROCEDURE WAS PROMPTED BY STABLE ANGINA. ONE RESOLUTE INTEGRITY STENT(RSINT30026JX) WAS USED IN THE PREVIOUSLY REPORTED TVR.
Additional Manufacturer Narrative · 1
CEC HAS ADJUDICATED THE MI HAS HAVING NO RELATIONSHIP TO THE STUDY DEVICE.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CEC HAS ADJUDICATED THAT THE PREVIOUSLY REPORTED MI WAS A TV NON QMI.
Description of Event or Problem · 1
A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED IN THE RCA DURING THE INDEX PROCEDURE. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED STEMI AND REVASCULARIZATION OF THE TARGET VESSEL WAS CARRIED OUT. CEC ADJUDICATED THE REVASCULARIZATION IS A TVR AND THE STEMI AS A MDT AND ARC MI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 489696 | RESOLUTE INTEGRITY RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Required Intervention |