FDA Adverse Event
Injury
Summary report: N
RESOLUTE ONYX RX
MDR report key: 8277624
·
Received January 25, 2019
Report
- Report Number
- 9612164-2019-00314
- Event Type
- Injury
- Date Received
- January 25, 2019
- Date of Event
- August 11, 2017
- Report Date
- July 2, 2019
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- UDI-DI
- 00643169557178
- PMA / PMN Number
- P160043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
CEC ADJUDICATED THE EVENT AS A MYOCARDIAL INFARCTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
CEC RE ADJUDICATED MI IN THE 1ST OBTUSE MARGINAL AS NO EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL. THE PATIENT SUFFERED ELEVATED TROPONIN PER PROCEDURE SAME DAY. CEC ADJUDICATED NON-Q-WAVE MI (TARGET VESSEL), MEDTRONIC EXTENDED HISTORICAL REINFARCTION POST PCI. CEC ADJUDICATED STENT THROMBOSIS NO EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 70019 | RESOLUTE ONYX RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND | 0008512049 | 00643169557178 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization |