MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-03 for TREVO XP PROVUE 4MM X 20MM 90182 manufactured by Stryker Neurovascular-utah-salt Lake City.
[181808026]
The subject device is not available to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[181808027]
It was reported that during thrombectomy for cardio embolic of left internal carotid artery(ica), terminus bifurcation was done with the subject retriever and aspiration catheter and successful recanalization was confirmed during the procedure. A few days later, symptomatic intracranial hemorrhage was confirmed in the patient and later the patient passed away. In the physician's opinion, subject retriever performed as intended during the procedure, the cause for the intracranial hemorrhage was bleeding due to the opening of the infarcted area, and the cause of the patient death was worsening of primary disease. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012931345-2020-00034 |
| MDR Report Key | 9781395 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-25 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-08-22 |
| Date Added to Maude | 2020-03-03 |
| 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 20MM |
| Generic Name | CATHETER, THROMBUS RETRIEVER |
| Product Code | NRY |
| Date Received | 2020-03-03 |
| Model Number | 90182 |
| Catalog Number | 90182 |
| Lot Number | 0000013521 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Death; 2. Other | 2020-03-03 |