MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-12 for TREVO XP PROVUE 6MM X 25MM 90186 manufactured by Stryker Neurovascular-utah-salt Lake City.
[183236515]
Subject device not available.
Patient Sequence No: 1, Text Type: N, H10
[183236516]
It was reported that a patient came with a stroke due to a thrombus in internal carotid artery, c1 segment and middle cerebral artery m1 right segment. Neurological assessment was national institutes of health stroke scale (nihss) of 15. Thrombectomy with the subject stent retriever was indicated with local anesthesia. During removal, the subject stent came off without resistance and remained in m1 vessel. Attempt to recover the stent with lasso failed and the ica siphon section was perforated. The patient suffered a major intracranial hypertension and sub arachnoid hemorrhage, was transferred to a neuro traumatic resuscitation unit, but passed away few hours post-procedure. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012931345-2020-00039 |
| MDR Report Key | 9826527 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-29 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-12 |
| 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 6MM X 25MM |
| Generic Name | CATHETER, THROMBUS RETRIEVER |
| Product Code | NRY |
| Date Received | 2020-03-12 |
| Model Number | 90186 |
| Catalog Number | 90186 |
| Lot Number | UNK |
| 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. Death; 2. Other; 3. Required No Informationntervention | 2020-03-12 |