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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 5MM X 30MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS 5MM X 30MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number 121FPP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Stenosis (2263); Speech Disorder (4415); Embolism/Embolus (4438)
Event Date 12/01/2021
Event Type  Injury  
Event Description
It was reported that left ica (internal carotid artery) c2 segment flow diverter implantation was performed in the patient with other relevant history of hyperlipidemia, osteoporosis. On the same day of procedure stenosis in subject flow diverter stent (stenosis rate: 1-25%) was noted. On the next day mri imaging was performed which revealed multiple micro embolism. The patient was reported to have stroke. According to the physician the stroke was non-serious but likely related to the procedure. Edaravone 30mg was administered twice a day for treatment of the stroke. On seventh of the procedure patient recovery was noted. Preoperative and postoperative antiplatelet therapy was performed according to the dosage schedule. Aspirin 100mg/day was giving to the patient from (b)(6) 2021, to now (ongoing). Patient was on clopidogrel 75mg/day for the time period of (b)(6) 2021 to (b)(6) 2021. Now patient is taking clopidogrel 5omg/day from (b)(6) 2022 (ongoing). The procedure was completed successfully. No other information is available.
 
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Brand NameSURPASS 5MM X 30MM - 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 Key14060374
MDR Text Key290164692
Report Number3008881809-2022-00164
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number121FPP
Device Lot Number22359217
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
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: 04/08/2022 Patient Sequence Number: 1
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