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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 30MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 30MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003112FPP0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Ischemia (1942); Paralysis (1997)
Event Date 04/21/2021
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 flow diverter stent placement for endovascular unruptured intracranial aneurysm was performed in ic-c2 (internal carotid) c2 segment. When distal access catheter was advanced at m1(middle cerebral artery: segment 1) before advancement of flow diverter, light ischemia (about 10 min) was confirmed near the distal end of the catheter. The ischemia was not related to the vasospasm and the cause of it is not clear. The physician told that ischemia may have happened by the distal end of catheter as it may have block/obstructed the blood flow to m1 distal. There was no intervention done for ischemia during the intra-operative period. In the doctor's opinion neurologic deficit appeared and it was related to the operation but was not caused solely by the subject flow diverter. The flow diverter has performed as intended. There were no issues noted with advancement, deployment of the device and after deployment, removing of sdw (stent delivery wire) from patient vasculature and full expansion of stent cell with apposition to vessel wall was achieved after implantation and confirmed under ct. The flow diverter has performed as intended. When the subject stent was successfully placed at the target site and the patient recovered from anesthesia, transient paralysis in left arm and leg noticed, in the physician's opinion ischemia led necrosis of nerve cells which may be the factor contributed to reported transient paralysis. The pre-operative ct (computerized tomography) and mir (magnetic resonance imaging) scan was normal for same anatomical location which caused transient paralysis. But the post-operative mri scan was positive for infarction. Paralysis has improved but not fully recovered. Patient will be receiving post- stroke rehabilitation therapy in another hospital or the patient will be discharge after some rehabilitation at his facility. The patient is receiving stroke medication or treatment due to the reported events. Patient outcome is ongoing.
 
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Brand NameSURPASS STREAMLINE 4.0MM 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 Key11816953
MDR Text Key250357722
Report Number3008881809-2021-00198
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,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberM003112FPP0
Device Lot Number22468539
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 Received07/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2020
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: 05/13/2021 Patient Sequence Number: 1
Treatment
8FRFUBUKI (UNKNOWN); AXS OFFSET DELIVERY ASSIST CATHETER (STRYKER); CAT 5 DISTAL ACCESS CATHETER (STRYKER); CHIKAIBLACK (UNKNOWN); EXCELSIORSL10 MICROCATHETER (STRYKER); TARGET COILS (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER); TRAXCESS14 (UNKNOWN)
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