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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PRO 18RO MICROCATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC

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STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PRO 18RO MICROCATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number 90238
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Coma (2417)
Event Date 10/12/2019
Event Type  Injury  
Event Description
It was reported that during the procedure for treating an acute ischemic stroke in the left middle cerebral artery, the stent retriever could not be advanced anymore or withdrawn from inside the subject catheter. The physician withdrew both the stent retriever and subject catheter from inside the patient anatomy as he considered the stent retriever to be damaged. This event resulted in a thirty-minute surgical delay during the procedure and the physician assumed the patient suffered a large area of cerebral infarction and passed into a coma from the surgical delay. There is no direct relationship between the device and the adverse event, but the physician thought that the patient with large area cerebral infarction because of the surgical delay. The procedure was completed successfully with another product. No further information is available.
 
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Brand NameTREVO PRO 18RO MICROCATHETER
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 Key9330495
MDR Text Key166636439
Report Number3012931345-2019-00091
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K113260
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 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/23/2021
Device Catalogue Number90238
Device Lot Number0000022918
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2019
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: 11/15/2019 Patient Sequence Number: 1
Treatment
TREVO PROVUE STENT RETRIEVER (STRYKER)
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