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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 - PMA INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 30MM - PMA INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number M003SFD040300
Device Problem Premature Activation (1484)
Patient Problems Aneurysm (1708); High Blood Pressure/ Hypertension (1908); Rupture (2208)
Event Date 05/06/2020
Event Type  Injury  
Manufacturer Narrative
The subject device remained inside patient.
 
Event Description
It was reported that during procedure the subject device (stent) was deployed prematurely in the wrong location. The subject device stent was fully deployed from middle cerebral artery (mca) to cavernous internal carotid artery (ica) and controlled bleeding to an extent but landed further distal than anticipated. The physician tried to drag the subject stent proximal into the ica and the patient¿s blood pressure spiked up which caused an aneurysm rupture near distal segment of supraclinoid ica. The subject device was unable to be removed once fully deployed so left in place and decided not to coil. The patient was administered with the medication in response to the aneurysm rupture. Patient had an evd (external ventricular drain) placed immediately after the procedure. Patient¿s current status is sick but stable.
 
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Brand NameSURPASS STREAMLINE 4.0MM X 30MM - PMA
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 Key10065501
MDR Text Key191261394
Report Number3008881809-2020-00150
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2020
Device Model NumberM003SFD040300
Device Catalogue NumberM003SFD040300
Device Lot Number21785957
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 Received07/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2019
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: 05/18/2020 Patient Sequence Number: 1
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