MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-05 for TREVO XP PROVUE 4MM X 20MM 90182 manufactured by Stryker Neurovascular-utah-salt Lake City.
[183128412]
Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release. The subject device was not returned. Therefore, visual and functional analysis were not performed. The reported event is covered in the device directions for use (dfu). As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event. Additional information provided by the customer indicated that the event occurred due to pre-existing condition. The trevo device performed as intended. The reported 'patient intracranial hemorrhage' is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use. Therefore, a probable cause of anticipated procedural complication will be assigned to this event. Device discarded at hospital.
Patient Sequence No: 1, Text Type: N, H10
[183128413]
It was reported that after a successful thrombectomy procedure performed at the basilar artery, intracranial hemorrhage was observed inside the patient? S anatomy within 24 hours after the procedure. The subject retriever was used during the procedure. In the physician? S opinion, the subject retriever performed as intended during the procedure and the reported adverse event was related to patient? S pre-existing condition. No additional clinical consequences were reported to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012931345-2020-00035 |
| MDR Report Key | 9795440 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-05 |
| Date of Report | 2020-04-02 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-05 |
| 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 RETREIVER |
| Product Code | NRY |
| Date Received | 2020-03-05 |
| Model Number | 90182 |
| Catalog Number | 90182 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-05 |