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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FDS40012
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cataract (1766); Loss of Vision (2139); Obstruction/Occlusion (2422); Ischemia Stroke (4418)
Event Date 04/30/2021
Event Type  Injury  
Manufacturer Narrative
The subject device remained inside patient.
 
Event Description
The patient was administered to the hospital in late april with a left ica (internal communicating artery) segment aneurysm. The aneurysm was incidentally found during screening mra (magnetic resonance angiogram). It was a small, approximately 3mm berry shaped aneurysm. Prior to the procedure, the patient was taking dapt, asa and brilinta. The patient had a family history of aneurysm rupture, so the decision was made to treat the aneurysm with a subject stent. The procedure went smoothly, and the patient was discharged that evening. It was reported that two weeks post flow diverter stent placement procedure, the patient presented with transient visual loss in right visual field, then blindness (few minutes) which completely resolved spontaneously. Pru was tested in the 50¿s. On imaging (computerized tomography ct head / cta/ ctp) indicating complete occlusion of left ica at proximal subject stent device with ¿slim sign¿. Ctp showed no deficit, slightly elevated tmax left hemisphere ((b)(4) distribution). Mr. (b)(6) showed small acute infarct splenium corpus callosum. The patient remains neurologically intact during 3-day hospital stay. The patient¿s current condition is asymptomatic.
 
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Brand NameSURPASS EVOLVE 4.0MM X 12MM - PMAS
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 Key12489265
MDR Text Key271940345
Report Number3008881809-2021-00387
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 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFDS40012
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 Received09/24/2021
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: 09/17/2021 Patient Sequence Number: 1
Treatment
105 7F RIST ((UNKNOWN MANUFACTURER)); 7F SHEATH (UNKNOWN MANUFACTURER); XT 27 MICROCATHETER (STRYKER)
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