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U.S. Department of Health and Human Services

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

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STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 20MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003110FPP0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paralysis (1997); Obstruction/Occlusion (2422); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Event Date 08/02/2021
Event Type  Injury  
Manufacturer Narrative
The device is not available to the manufacturer, as device is implanted in patient.
 
Event Description
It was reported that endovascular flow diverter stent placement for ic (internal carotid artery) was performed in the patients with unruptured aneurysm on july 16 and the full expansion of stent cell with apposition to vessel wall was achieved after implantation and was confirmed under fluoroscopy. According to the physician the device performed as indented. The day after the discharged ic (internal carotid artery) occlusion occurred due to in stent thrombosis and occlusion of the stent lumen by thrombus. Patient was reported to have neurological deficit in the form of paralysis. This adverse event resulted in inpatient hospitalization or prolongation of existing hospitalization. Patient outcome is ongoing.
 
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Brand NameSURPASS STREAMLINE 4.0MM X 20MM - 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 Key12401901
MDR Text Key269326276
Report Number3008881809-2021-00355
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 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberM003110FPP0
Device Lot Number22469417
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 Received08/03/2021
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: 08/31/2021 Patient Sequence Number: 1
Treatment
AXCELGUIDE GUIDING CATHETER (UNKNOWN); CAT5 DISTAL ACCESS CATHETER (STRYKER); CHIKAI014 GUIDEWIRE (ASAHI)
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