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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 20MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 20MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD32520
Device Problems Premature Activation (1484); Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2020
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during the procedure, physician attempted to deploy subject stent at left supraclinoid ica (internal carotid artery). Physician noted that only more than half the subject stent could deploy and was unable to deploy it further. Physician attempted to re-sheath the subject stent and the microcatheter used in the procedure would also move with the subject device distally. Both devices were removed together and replaced with similar devices. The procedure was completed successfully. No clinical consequences were reported to the patient due to this event.
 
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Brand NameSURPASS EVOLVE 3.25MM X 20MM - 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 Key10637967
MDR Text Key210223413
Report Number3008881809-2020-00287
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/09/2020
Device Catalogue NumberFD32520
Device Lot Number21931743
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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