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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 40MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 40MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003113FPP0
Device Problem Activation Failure (3270)
Patient Problems Vasoconstriction (2126); Movement Disorder (4412)
Event Date 08/18/2021
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 intracranial endovascular stent implantation procedure was performed for internal carotid artery ( ica) aneurysm. After the subject stent deployment a slight crimp in the proximal part of the stent was noted. When post operatively an mri scan was performed, vasoconstriction caudally to endovascular stent implantation site (middle cerebral artery) was noted. Vasoconstriction leads to reduced blood flow which was partial and temporally, with faint diffuse findings in the m1 (middle cerebral artery - segment m1) perforator limb and borderline areas. The patient was unable to type on the keyboard which was considered to be appeared temporally as this muscle weakness disappeared on (b)(6) 2021 (next day of the event). The procedure was completed and no other information is available.
 
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Brand NameSURPASS STREAMLINE 4.0MM X 40MM - 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 Key12483118
MDR Text Key271757582
Report Number3008881809-2021-00383
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 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberM003113FPP0
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 Received08/23/2021
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: 09/16/2021 Patient Sequence Number: 1
Treatment
AXS INFINITYLS 80CM (STRYKER); CAT5 125CM (STRYKER); GEATWAY MR 3.0MM/12MM (STRYKER); SL-10 2M (STRYKER); SYNCHRO2 STD (STRYKER); TARGETXLSOFT 6MM/20CM (STRYKER); TARGETXLSOFT 8MM/30CM (STRYKER); TRANSFORM 7MM/7MM (STRYKER)
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