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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 3X20 INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS 3X20 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003101FPP0
Device Problem Activation Failure (3270)
Patient Problem Thrombosis (2100)
Event Date 11/18/2019
Event Type  Injury  
Manufacturer Narrative
This is 1 of the 2 reports. The device remains implanted in patient.
 
Event Description
It was reported that after approximately 18 months post stenting procedure, intra-stent thrombosis in the proximal part of the distal stent due to the bad apposition on the vessel wall was noted with high-resolution cone-beam computed tomography (vasoct). Medication of ticagrelor was administrated to the patient as a required treatment. No further information is available.
 
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Brand NameSURPASS 3X20
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key9536387
MDR Text Key173243334
Report Number3008881809-2019-00417
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P170024
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 01/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberM003101FPP0
Device Lot Number19209416
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 Received01/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2016
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: 12/31/2019 Patient Sequence Number: 1
Treatment
SURPASS 3X20 (STRYKER)
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