MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-03-27 for UNKNOWN_NEUROVASCULAR_PRODUCT UNK_NEU manufactured by Stryker Neurovascular-utah-salt Lake City.
[186008754]
This is the first of 3 reports. Subject device not available.
Patient Sequence No: 1, Text Type: N, H10
[186008755]
It was reported that the patient presented with left stroke with m1 occlusion (nihss=15) by mir. Thrombectomy was performed with 7 attempts with stent retriever (3 stryker subject devices) and 4 non- stryker devices). Post-procedure there was immediate improvement (nihss=1). A few hours after the intervention, the patient experienced intense headache with left temporoparietal hematoma due to hemorrhagic stroke transformation (nihss=5) without immediate indication of surgery. The patient was transferred next day for monitoring and is still recovering from intracerebral hemorrhage. According to the physician, the relationship of the intracerebral hemorrhage was assessed as? Reasonable possibly to the experimental procedure?.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012931345-2020-00049 |
| MDR Report Key | 9890727 |
| Report Source | STUDY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-29 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-27 |
| 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 | UNKNOWN_NEUROVASCULAR_PRODUCT |
| Generic Name | CATHETER, THROMBUS RETRIEVER |
| Product Code | NRY |
| Date Received | 2020-03-27 |
| Catalog Number | UNK_NEU |
| 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 | 2020-03-27 |