• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM CATHETER, THROMBUS RETRIEVER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM CATHETER, THROMBUS RETRIEVER Back to Search Results
Model Number 90186
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Embolism (1829)
Event Date 04/03/2020
Event Type  Injury  
Manufacturer Narrative

Subject device is not available.

 
Event Description

It was reported that during thrombectomy in the right cervical internal carotid artery (ica), proximal right m1 - the subject stent retriever was used in combination with a catheter. Embolization to new territory from right m1 to m2 occurred after one pass. Thrombectomy for right m2 was performed with a non-stryker stent retreiver and aspiration catheter and it resolved. It was also reported that vessel perforation occurred during procedure, but it was not related to the subject stent retriever. Patient status reported as mrs:4. No further information is available.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTREVO XP PROVUE 6MM X 25MM
Type of DeviceCATHETER, THROMBUS RETRIEVER
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 Key10216213
MDR Text Key197084568
Report Number3012931345-2020-00093
Device Sequence Number1
Product Code NRY
Combination Product (Y/N)N
PMA/PMN NumberK143077
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 08/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number90186
Device Catalogue Number90186
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2020
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: 06/30/2020 Patient Sequence Number: 1
Treatment
CATALYST 6 CATHETER (STRYKER)
-
-