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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number UNK_NEU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seizures, Focal (2260)
Event Date 12/06/2019
Event Type  Injury  
Manufacturer Narrative
This is the 13 of 14 reports. Subject device remains implanted.
 
Event Description
It was published in a literature abstract that cases performed between 10-jan-2019 to 02-jan-2020 on a total of 55 patients with 68 treated aneurysms were treated with flow diverter (subject device). There were procedure related complications reported in 12 patients. One patient was treated with implant of a flow diverter (subject device) for unruptured aneurysm on the left ophthalmic artery with partial thrombosis, 12 mm (aneurysm size 10-20mm). The patient experienced seizures same day as procedure with focus on same side as treated aneurysm. Possibly inflamed post procedure 2/2 increased thrombus. Outcome of the patient is remaining on anti-seizure medication.
 
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Brand NameUNKNOWN_NEUROVASCULAR_PRODUCT
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key10103958
MDR Text Key193660690
Report Number3008881809-2020-00162
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170024
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 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_NEU
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 Received07/07/2020
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: 05/31/2020 Patient Sequence Number: 1
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