MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-18 for TREVO XP PROVUE 4MM X 30MM 90185 manufactured by Stryker Neurovascular-utah-salt Lake City.
[188842284]
The subject device is unavailable to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[188842285]
It was reported that during a thrombectomy procedure, the subject device retriever was done for right middle cerebral artery (mca-m2) and ent (embolization to new territory) was observed in right a1 segment. Ent was treated using the retriever and tici (thrombolysis in cerebral infaction) was achieved as grade 3. Approximately 5-7 days post the index procedure, the patient was discharged and the patient was assessed having a nihss (national institute of health stroke scale) of 1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012931345-2020-00043 |
| MDR Report Key | 9850302 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-09 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TARA LOPEZ |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104132500 |
| Manufacturer G1 | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY |
| Manufacturer Street | 4870 WEST 2100 SOUTH |
| Manufacturer City | SALT LAKE CITY UT 84120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TREVO XP PROVUE 4MM X 30MM |
| Generic Name | CATHETER, THROMBUS RETRIEVER |
| Product Code | NRY |
| Date Received | 2020-03-18 |
| Model Number | 90185 |
| Catalog Number | 90185 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY |
| Manufacturer Address | 4870 WEST 2100 SOUTH SALT LAKE CITY UT 84120 US 84120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-18 |