MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PRO 14 MICROCATHETER 157CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 90231

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 4th of 6 records.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 pro 14 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.

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 events are covered in the device directions for use (dfu).As well, the risk of the reported events are 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 issues, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.

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 pro 14 microcatheter.The survey was conducted in australia, france, germany, italy, japan, spain, united kingdom 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.

• Brand Name: TREVO PRO 14 MICROCATHETER 157CM
• Type of Device: 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: 12838996
• MDR Text Key: 280998907
• Report Number: 3012931345-2021-00192
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• 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 Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other