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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 20MM - IDE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 20MM - IDE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FDC40020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Visual Disturbances (2140)
Event Date 03/31/2021
Event Type  Injury  
Manufacturer Narrative
Device is not available to manufacturer.
 
Event Description
It was reported that during the clinical trial, 13 days post a successful procedure of an aneurysm in the internal carotid artery-ophthalmic (c6 segment) with the subject flow diverter, the patient experienced intermittent left eye visual disturbance. Relationship of the event to the procedure and subject device is reported as possible. An eye exam was performed by an optometrist on the same day which showed a normal retina with no issues. A diagnostic test was performed on (b)(6) 2021, which was an antiplatelet efficacy test and the platelet reaction unit (pru) was 52. There was no reported treatment initiated for the event. There was no imaging performed during the 1month visit on (b)(6) 2021. Event is reported to be ongoing but resolving. No other information is available.
 
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Brand NameSURPASS EVOLVE 4.0MM X 20MM - 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 Key11794882
MDR Text Key249676211
Report Number3008881809-2021-00189
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFDC40020
Device Lot Number22436459
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 Manufactured09/03/2020
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: 05/07/2021 Patient Sequence Number: 1
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