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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 Problem Malposition of Device (2616)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that va dissecting of aneurysm was performed with subject flow diverter. Subject flow diverter was deployed at distal of the lesion and did not cover the lesion completely. Physician proceeded to use another flow diverter to cover the remainder of the lesion. The procedure was completed successfully, and patient was discharged the following day. Two days post operation, patient was hospitalized due to total occlusion of lesions. Patient is reported not to have taken prescribed medication when occlusion occurred. Patient had first thrombectomy performed. Four days post operation, the lesions blocked again. A second thrombectomy was done and patient condition is reported as stable. No other information is available.
 
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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 Key10932551
MDR Text Key219115023
Report Number3008881809-2020-00372
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeKS
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 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2021
Device Catalogue NumberFD32520
Device Lot Number22336994
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 Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2020
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: 12/02/2020 Patient Sequence Number: 1
Treatment
SURPASS EVOLVE 3.25MM X 25MM (STRYKER)
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