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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK 4 X 40 SURPASSTM SYSTEM INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK 4 X 40 SURPASSTM SYSTEM INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number 113FPP
Device Problem Activation Failure (3270)
Patient Problems Neurological Deficit/Dysfunction (1982); Weakness (2145)
Event Date 08/21/2019
Event Type  Injury  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
It was reported that the subject device stent flow diver was correctly affixed to the site to be treated (at the beginning of the middle cerebral artery m1 through the bifurcation and ending at the supraclinoid carotid artery). At halfway through the release of the device it remained closed, the device was attempted to be re-sheathed which was not possible because the external catheter could not advance over the device. As such, the physician recapped the device using the distal catheter and ultimately successfully removed it. Then a new stent device was deployed that worked as expected. Immediately after the procedure when the patient woke up completely, hemiparesis was found. The physician performed a new arteriography to see if there was thrombosis of the implanted subject stent or what would be the cause of hemiparesis. The exam was angiographically normal and it was not possible to determine the cause of hemiparesis since there was no large caliber arterial branch occlusion it cannot be affirmed but there are 3 possible causes: long time of vasospasm in the internal carotid artery during the procedure when the introducer sheath advanced to try opening the device correctly. Device has compressed the output of a minimum caliber piercing branch. An embolic event during the procedure in a very small branch that was not visible on arteriography. Physician reported that the deficit recovery was spontaneous, and no specific medication was used for treatment only the normal double anti aggregation recommended when stenting implanted, speech and physical therapy. The patient outcome was satisfactory and was discharged with minimal deficit in the right arm but he will probably recover fully.
 
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Brand Name4 X 40 SURPASSTM SYSTEM
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 Key8997006
MDR Text Key161544872
Report Number3008881809-2019-00266
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
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 11/06/2019
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 Date04/29/2021
Device Catalogue Number113FPP
Device Lot Number20507533
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2018
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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