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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 4X20 INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS 4X20 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003110FPP0
Device Problem Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2018
Event Type  malfunction  
Manufacturer Narrative
Device not returned.
 
Event Description
It was reported that during the procedure, the stent (subject device) did not expand. Another device was used to complete the procedure. There were no clinical consequences to the patient reported due to this event.
 
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Brand NameSURPASS 4X20
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key8192699
MDR Text Key131308813
Report Number3008881809-2018-00544
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/06/2021
Device Catalogue NumberM003110FPP0
Device Lot Number20378855
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2018
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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