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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 15MM - IDE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 15MM - IDE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FDC50015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of Vision (2139)
Event Date 01/28/2021
Event Type  Injury  
Manufacturer Narrative
This is 4 of 4 reports. : device is not available to manufacturer.
 
Event Description
It was reported that following a procedure with the subject flow diverter in a clinical trial, the patient experienced intermittent episodes of left arm numbness which started and stopped on the same day. Imaging on the day after event onset showed no evidence of acute abnormality involving the major cervical or intracranial arteries. Mri of cervical spine was normal. Patient was kept in hospital for observation and medication was administered (oral cyclobenzaprine 10 mg tid). The event was reported as resolved. Cec assessed the event as possibly related to other stryker devices (synchro 2 standard guide wire, axs catalyst 5 catheter, excelsior xt-27 micro catheter), procedure, disease under study, and underlying condition or disease. The investigator also included transient ischemic attack of uncertain etiology as the cause of the event. It was also reported that the patient experienced transient left sided vision loss as a result of baseline headache / migraine disorder. Imaging on the day after event onset showed no acute infarct or abnormal enhancement. Patient was kept in hospital for observation and medication was administered (oral acetaminophen, 650 mg prn). The event was reported as resolved. The cec assessed the event as possibly related to the subject flow diverter, other stryker devices (synchro 2 standard guide wire, axs catalyst 5 catheter, excelsior xt-27 micro catheter), procedure, dual antiplatelet therapy and disease under study. No further information is available.
 
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Brand NameSURPASS EVOLVE 5.0MM X 15MM - IDE
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 Key12005698
MDR Text Key256454235
Report Number3008881809-2021-00257
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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 09/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/19/2021
Device Catalogue NumberFDC50015
Device Lot Number22081705
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 Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2020
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: 06/15/2021 Patient Sequence Number: 1
Treatment
AXS CATALYST 5 CATHETER (STRYKER); EXCELSIOR XT-27 MICRO CATHETER (STRYKER); SYNCHRO 2 STANDARD GUIDE WIRE (STRYKER)
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