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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD32512
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Transient Ischemic Attack (2109); Blurred Vision (2137)
Event Date 10/09/2020
Event Type  Injury  
Manufacturer Narrative
This is 1 of 5 reports. Is implanted in patient.
 
Event Description
It was reported in the clinical trial that one day post procedure in the internal carotid artery-ophthalmic (c6 segment), the patient developed left upper limb weakness which resolved the next day. Unknown drug treatment was administered and the event resolved. 12 days post procedure, the patient also developed right eye visual blurring which resolved after fourteen days. No treatment was given for this event. 202 days post procedure, the patient had a transient ischemic attack (tia) which presented with left sided numbness and weakness in the face, upper and lower limbs. The tia resolved the next day after unknown drug treatment was administered. Imaging done post tia was unremarkable. All 3 events had possible relation to the flow diverter. The left upper limb weakness had possible relation to the procedure, dual antiplatelet therapy and other stryker devices used in the procedure. The tia had possible relation to the procedure. No other information is available.
 
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Brand NameSURPASS EVOLVE 3.25MM X 12MM - CE
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 Key11873657
MDR Text Key252426388
Report Number3008881809-2021-00213
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAS
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,Followup
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/25/2021
Device Catalogue NumberFD32512
Device Lot Number22165335
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 Received07/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2020
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: 05/24/2021 Patient Sequence Number: 1
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