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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD32512
Device Problems Malposition of Device (2616); Premature Separation (4045)
Patient Problem Hypovolemia (2243)
Event Date 09/16/2020
Event Type  Injury  
Manufacturer Narrative
The subject device remained implanted.
 
Event Description
It was reported that the patient presented to the hospital with ruptured internal carotid artery (rica) aneurysm. The patient was previously treated for a left internal carotid artery (lica). During the procedure the two surpass evolve¿s failed to fully open when unsheathed inside the patient anatomy. The physician did not experience any issue with tortuosity. Stryker sales representative felt that the sizing of the two surpass was not correct and advised a wider stent the same length to be used. The first evolve jumped in the system when flushed during preparation. The third subject surpass evolve was used and was deployed prematurely in the patient¿s anatomy without meaning to deploy it. The subject surpass evolve had twisted in the bend of the artery but had opened up both proximally and distally. The physician attempted to remove the subject surpass evolve but was not successful. The patient had started to lose a lot of blood in the groin and the sales representative reported hearing that the team request her blood type to get ready for the patient. The procedure was about 6 or 7 hours long. No other information was provided.
 
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Brand NameSURPASS EVOLVE 3.25MM X 12MM - 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 Key10659918
MDR Text Key211006136
Report Number3008881809-2020-00298
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
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 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/09/2021
Device Catalogue NumberFD32512
Device Lot Number22194408
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 Received10/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2020
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: 10/10/2020 Patient Sequence Number: 1
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