MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-28 for UNKNOWN_NEUROVASCULAR_PRODUCT UNK_NEU manufactured by Stryker Neurovascular-utah-salt Lake City.
[181478970]
The subject device is unavailable to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[181478971]
It was reported that after the study procedure to 48 hours post procedure, the intracerebral hemorrhage 72x55mm on the left hemisphere, haematocephalus, midline shift 16mm occurred and caused the neurologic deterioration. Based on the site, the hemorrhage was related to the retriever (subject device), index stroke and index procedure. Unknown what type of medical management was performed. The patient subsequently passed away on the same day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012931345-2020-00033 |
| MDR Report Key | 9772306 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-16 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-02-28 |
| 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 | 2020-02-28 |
| Catalog Number | UNK_NEU |
| 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; 3. Required No Informationntervention | 2020-02-28 |