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

Model Number	90338
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
This is the 5th of 6 reports.The subject device not returned.
Event or Problem 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 mortality was reported.No other information is available about this event.
Additional Manufacturer Narrative
Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional testing could not be performed since the product was not returned as this complaint refers to a pmcf survey.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
Event or Problem 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 australia, france, germany, italy, japan, spain, united kingdom and united states.During the survey mortality was reported.No other information is available about this event.

• Brand Name: TREVO TRAK 21 MICROCATHETER 162CM
• Common Device Name: CATHETER, 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 Key: 12839011
• Report Number: 3012931345-2021-00193
• Device Sequence Number: 4950343
• Product Code: DQO
• UDI-Device Identifier: 07613327313956
• UDI-Public: 07613327313956
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 90338
• Device Catalogue Number: 90338
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 02/12/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown