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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 15MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 15MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FDS32515
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Fistula (1862); Paresis (1998); Vascular Dissection (3160)
Event Date 07/21/2021
Event Type  Injury  
Manufacturer Narrative
Device is not available to manufacturer.
 
Event Description
It was reported that a stent (subject device) was implanted successfully during a procedure at pcom to opthalmic region. The patient was reported to have moderately tortuous anatomy. During a two day follow up, it was noted that the subject stent had dissected the vessel at ica causing fistula. It was also reported that the patient had weakness and small stroke. As per the physician, the adverse events were due to the patient's anatomy and the subject stent performed as intended during the procedure. The patient¿s current condition is reported to be stable and is being monitored with follow up visits. No other clinical consequences were reported to the patient due to this event.
 
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Brand NameSURPASS EVOLVE 3.25MM X 15MM - 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 Key12329151
MDR Text Key266850030
Report Number3008881809-2021-00339
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 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFDS32515
Device Catalogue NumberFDS32515
Device Lot Number22241034
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 Received07/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/16/2021 Patient Sequence Number: 1
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