UNKNOWN_NEUROVASCULAR_PRODUCT UNK_NEU

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number3012931345-2020-00033
MDR Report Key9772306
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-28
Date of Report2020-03-27
Date of Event2020-02-16
Date Mfgr Received2020-03-06
Date Added to Maude2020-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. TARA LOPEZ
Manufacturer Street47900 BAYSIDE PARKWAY
Manufacturer CityFREMONT CA 94538
Manufacturer CountryUS
Manufacturer Postal94538
Manufacturer Phone5104132500
Manufacturer G1STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
Manufacturer Street4870 WEST 2100 SOUTH
Manufacturer CitySALT LAKE CITY UT 84120
Manufacturer CountryUS
Manufacturer Postal Code84120
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN_NEUROVASCULAR_PRODUCT
Generic NameCATHETER, THROMBUS RETRIEVER
Product CodeNRY
Date Received2020-02-28
Catalog NumberUNK_NEU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
Manufacturer Address4870 WEST 2100 SOUTH SALT LAKE CITY UT 84120 US 84120


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Other; 3. Required No Informationntervention 2020-02-28

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