MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for RESOLUTE ONYX? RONYX22526UX manufactured by Medtronic, Inc..
[185722288]
The onyx stent sheared off of the angioplasty balloon and was undeployed in the right angle portion where the 1st diagonal branches from the lad. The stent was still on the coronary wire but unexpanded and undeployed (as unintended). A second wire was placed parallel to the "working-wire" a ptca balloon was placed adjacent to the undeployed stent and was inflated to "crush" the stent against lad & diagonal wall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902702 |
| MDR Report Key | 9902702 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-12-04 |
| Report Date | 2020-03-04 |
| Date Reported to FDA | 2020-03-04 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOLUTE ONYX? |
| Generic Name | CORONARY DRUG-ELUTING STENT |
| Product Code | NIQ |
| Date Received | 2020-03-31 |
| Model Number | RONYX22526UX |
| Catalog Number | RONYX22526UX |
| Lot Number | 0009759191 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 710 MEDTRONIC PKWY MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |