MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for MEDTRONIC SOLITAIRE X REVASCULARIZATION DEVICE 4MM X 40MM /STENT manufactured by Micro Therapeutic Inc/ Medtronic Inc..
[177400957]
Solitaire stent retriever being used for a mechanical thrombectomy procedure became separated from its delivery wire. It was deployed in the pt's carotid artery. Solitair delivery wire detached from stent retriever device at carotid siphon (location of intracranial stenosis) during retrieval; stent left in place at level of stenosis. Delivery wire fragment retrieved with snare. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092657 |
| MDR Report Key | 9653617 |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-20 |
| Date Added to Maude | 2020-01-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | MEDTRONIC SOLITAIRE X REVASCULARIZATION DEVICE 4MM X 40MM /STENT |
| Generic Name | NEUROVASCULAR MECHANICAL THROMBECTOMY DEVICE FOR ACUTE ISCHEMIC STROKE TREATMENT |
| Product Code | POL |
| Date Received | 2020-01-30 |
| Lot Number | A861719 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTIC INC/ MEDTRONIC INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-30 |