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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 3X25 INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS 3X25 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003102FPP0
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); No Consequences Or Impact To Patient (2199)
Event Date 02/07/2019
Event Type  Injury  
Manufacturer Narrative
The subject device remains implanted.
 
Event Description
Approximately ten months after the stenting procedure at right internal carotid, ophthalmic region, it was reported that the patient experienced memory loss and fatigue. No treatment was provided to the patient and the patient was not hospitalized. The patient neurological assessment showed mrs (modified rankin scale) of 4 post event. According to the physician, the adverse event is not known to be related to the procedure, unrelated to the stent delivery system (subject device) and the relation to implant was unknown. No further information is available for now.
 
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Brand NameSURPASS 3X25
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key8656778
MDR Text Key146615405
Report Number3008881809-2019-00149
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeNL
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,Followup,Followup
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberM003102FPP0
Device Lot NumberUNKNOWN
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 Received04/01/2020
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: 05/30/2019 Patient Sequence Number: 1
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