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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number UNK_NEU
Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109)
Event Date 05/20/2019
Event Type  Injury  
Manufacturer Narrative
The subject device remains implanted in patient.
 
Event Description
It was reported that the patient suffered a transient ischemic attack (tia) and symptoms of brachiofacial motor deficit post procedure. The physician administered agrastat iv (anticoagulant) as medical intervention and remains hospitalized for observation. The relationship between the device and the patient event is unknown and no additional information is available.
 
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Brand NameUNKNOWN (SURPASS STREAMLINE)
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key8667484
MDR Text Key241261730
Report Number3008881809-2019-00153
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Patient Monitoring
Type of Report Initial,Followup,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/10/2020
Device Catalogue NumberUNK_NEU
Device Lot Number21280814
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 Received11/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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