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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD40017
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of consciousness (2418); Syncope/Fainting (4411)
Event Date 06/22/2021
Event Type  Death  
Manufacturer Narrative
Device remains implanted in the patient.
 
Event Description
It was reported that a stent (subject device) was implanted successfully in aneurysm located at superior cerebral artery on (b)(6) 2021. The subject stent performed as intended. The procedure was completed successfully without any adverse events and the patient was discharged home asymptomatic. The patient was put on antibiotics for the urinary tract infection (uti) after discharged and was on dual anti platelets following the procedure. 5 days post procedure, the patient was presented to the hospital with uti, felt clammy and then fainted. It was reported that the family decided to withdraw care and patient passed away. The relationship between stryker device and death of the patient is unknown at this time. The uti was not related to stryker device. No further information is available.
 
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Brand NameSURPASS EVOLVE 4.0MM X 17MM - 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 Key12183560
MDR Text Key262031332
Report Number3008881809-2021-00303
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
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFD40017
Device Lot Number21505220R
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 Received09/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2019
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: 07/16/2021 Patient Sequence Number: 1
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