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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD40015
Device Problem Activation Failure (3270)
Patient Problems Aneurysm (1708); Paralysis (1997); Movement Disorder (4412); Thrombosis/Thrombus (4440)
Event Date 09/14/2021
Event Type  Injury  
Manufacturer Narrative
Device is implanted in patient.
 
Event Description
It was reported that a procedure was performed to treat a recanalized aneurysm in the ophthalmic segment of the internal carotid that had been previously treated with coils months ago. The goal was to implant a flow shunt so that the aneurysm closed completely. It was reported that during the procedure, everything went perfectly, the navigation of the subject flow diverter, its release, as well as the final result, which was excellent (wide open in the vessel covering the neck of the aneurysm). One hour post procedure, the patient woke up with a hemiplegia and immediately underwent a ct scan. The patient was taken to the interventional neuroradiology room where a 3d arteriography was performed. It was seen that the subject flow diverter was occluded proximally, forming "one fish mouth / cone-shaped", and was thrombosed. The physicians decided to inject fibrinolytic to dissolve the thrombus, which was successful, as well as for the proximal part of the implant to recover its usual morphology, allowing them to introduce a microguide and microcatheter to later implant a neuroform atlas intracranial stent which, by its radial force, kept the subject flow diverter open and permeable in the area where it had been occluded. The patient woke up with a problem in her arm, but the symptoms improved considerably compared to the previous hours. No other information is currently available.
 
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Brand NameSURPASS EVOLVE 4.0MM X 15MM - 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 Key12580382
MDR Text Key274939352
Report Number3008881809-2021-00417
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P170024/S003
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 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFD40015
Device Lot Number21805678R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2019
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: 10/05/2021 Patient Sequence Number: 1
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