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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STENT DELIVERY SYSTEM 3MMX20MM INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS STENT DELIVERY SYSTEM 3MMX20MM INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003SFD030200
Device Problem Premature Separation (4045)
Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)
Event Date 08/20/2019
Event Type  Injury  
Manufacturer Narrative
This is 1 of the 5 reports. The subject device is not available.
 
Event Description
During the procedure, it was reported that the flow diverter (subject device) was inserted into the catheter to reach the target lesion, but the flow diverter could not be deployed due to the tortuosity in ica (internal carotid artery). So the device was removed but the device was prematurely deployed in the catheter during removal. Therefore, the physician retrieved both the flow diverter and catheter together. Then the second attempt was made with a new flow diverter and a new catheter, and it was successful. Post balloon angioplasty was performed with balloon catheter, and the patient woke up fine. However, the same day after the procedure, the patient experienced right sided weakness prior to discharge. Upon scan, it was determined that the patient had experienced multiple small strokes and was not doing well. Hence, the patient had to stay in the hospital for monitoring longer than anticipated due to symptoms. The patient is discharged now with some symptoms maintain. In the physician¿s opinion, the patient¿s post procedure complication was causally related to the vessel manipulation, and the vessel manipulation was due to the need for removal of the system (flow diverter and catheter) and advancement of a new system (flow diverter and catheter) into the anatomy. Post balloon angioplasty was also performed post deployment to help the device ¿open¿ for wall apposition.
 
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Brand NameSURPASS STENT DELIVERY SYSTEM 3MMX20MM
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 Key8998367
MDR Text Key160445135
Report Number3008881809-2019-00267
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 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/09/2010
Device Catalogue NumberM003SFD030200
Device Lot Number21131859
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 Received09/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2019
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: 09/11/2019 Patient Sequence Number: 1
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