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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 25MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 25MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD50025
Device Problem Activation Failure (3270)
Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 06/15/2021
Event Type  Injury  
Manufacturer Narrative
Device remains implanted in the patient.
 
Event Description
It was reported that during the procedure the flow diverting stent (subject device) did not open when deployed at the target site inside the patient's anatomy. The instruction form the direction of use of the subject stent was followed during the procedure. When the subject stent failed to open, the physician decided to deploy it completely. The physician advanced a microcatheter to recapture the subject stent and massage it gently to open the subject stent but it was unsuccessfully. The physician then decided to dilate a balloon catheter and inflated it 3 times. The physician then implanted a new stent in the proximal part of the subject stent. At this point, intra-stent thrombi were evident and medication (tirofiban) was given to the patient. A completely occluded carotid artery was observed during the procedure. Even though the patient was under 8 days of dual antiplatelet therapy (before the procedure), it was observed angiographically that the patient had collateral filling by other branches. The next day, the patient underwent angiographic control without any complications. It was reported that the patient had a prolonged hospital stay for patient vigilance. No further information is available.
 
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Brand NameSURPASS EVOLVE 5.0MM X 25MM - 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 Key12197660
MDR Text Key262490155
Report Number3008881809-2021-00305
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
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 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFD50025
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 Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2019
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: 07/20/2021 Patient Sequence Number: 1
Treatment
ACLINO STENT (ACANDIS); TRANSFORM BALLOON CATHETER (STRYKER); UNKNOWN MICROCATHETER
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