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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO TRAK 21 MICROCATHETER 162CM CATHETER, INTRAVASCULAR, DIAGNOSTIC

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STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO TRAK 21 MICROCATHETER 162CM CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 90338
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Hematoma (1884); Vasoconstriction (2126); Perforation of Vessels (2135); Rupture (2208); Obstruction/Occlusion (2422); Thromboembolism (2654); Vascular Dissection (3160)
Event Date 11/04/2021
Event Type  Injury  
Manufacturer Narrative
This is the 6th of 6 reports. The subject device not returned.
 
Event Description
57 endovascular neurosurgeons, 78 interventional cardiologists, 6 interventional neurologists, 9 interventional neuroradiologists, and 36 interventional radiologists participated in the post-market clinical follow-up (pmcf) anonymous survey for subject trevo trak 21 microcatheter. The survey was conducted in (b)(6) and united states. During the survey hemorrhagic complication, re-occlusion, vessel dissection, clot embolization, neurological deficits, aneurysm recurrence, vessel perforation, stroke/tia, vasospasm, and groin hematoma were reported. No other information is available about this event.
 
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Brand NameTREVO TRAK 21 MICROCATHETER 162CM
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
Manufacturer (Section G)
STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
4870 west 2100 south
salt lake city UT 84120
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key12838143
MDR Text Key280998914
Report Number3012931345-2021-00189
Device Sequence Number1
Product Code DQO
UDI-Device Identifier07613327313956
UDI-Public07613327313956
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192122
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number90338
Device Catalogue Number90338
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/18/2021 Patient Sequence Number: 1
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