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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 20MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 20MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FDS50020
Device Problem Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  malfunction  
Event Description
It was reported during the procedure that the subject stent prematurely deployed while attempting to re-sheath. The physician replaced it with a new device and completed the procedure without clinical consequences to the patient.
 
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Brand NameSURPASS EVOLVE 5.0MM X 20MM - PMAS
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 Key12457336
MDR Text Key271048974
Report Number3008881809-2021-00372
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
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFDS50020
Device Catalogue NumberFDS50020
Device Lot Number22660968
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? No
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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