FDA Adverse Event
Other
Summary report: N
RESOLUTE ONYX
MDR report key: 21620964
·
Received March 17, 2025
Report
- Report Number
- MW5167727
- Event Type
- Other
- Date Received
- March 17, 2025
- Report Date
- March 12, 2025
- Manufacturer
- MEDTRONIC VASCULAR
- Product Code
- NIQ
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- *
Narratives
Description of Event or Problem · 0
STENT BALLOON RUPTURED DURING STENT DEPLOYMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6036 | RESOLUTE ONYX | CORONARY DRUG-ELUTING STENT | NIQ | MEDTRONIC VASCULAR | 0012268408 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |