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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 15MM - IDE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 15MM - IDE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FDC50015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Transient Ischemic Attack (2109)
Event Date 12/02/2021
Event Type  Injury  
Manufacturer Narrative
Device is implanted in patient.
 
Event Description
It was reported that in a clinical trial procedure to treat a right internal carotid artery-ophthalmic (c6 segment) aneurysm with the subject flow diverter, the patient had a transient ischemic attack which presented as 5 minutes of visual sensations on the left side post procedure. Imaging done showed normal findings. The event resolved on the same day without any treatment. The site reported the event as possibly related to the subject device.
 
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Brand NameSURPASS EVOLVE 5.0MM X 15MM - IDE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key13311051
MDR Text Key284630728
Report Number3008881809-2022-00029
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P170024/S003
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 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFDC50015
Device Lot Number21805887
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2019
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: 01/20/2022 Patient Sequence Number: 1
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