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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FDS40012
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Obstruction/Occlusion (2422)
Event Date 01/07/2021
Event Type  Injury  
Manufacturer Narrative
The subject device remained inside patient.
 
Event Description
It was reported that the patient with a previously ruptured right pcom (posterior communicating artery) region aneurysm. The aneurysm was previously coiled and it was approximately a 5mm aneurysm with a small recurrence was noted. Pru at the time the occlusion was observed was 236. The physician decided to treat with a subject 4. 0x12mm surpass evolve. The date of the procedure was (b)(6) 2021. The procedure went smoothly, and the device performed as expected. The patient was discharged on dapt (dual antiplatelet therapy). On routine 6-month follow-up on (b)(6) 2021, the ica (internal carotid artery) appeared occluded at the level of the device. It was unknown what was the reason for the vessel occlusion. The patient¿s current condition is asymptomatic and functioning as normal. No other information was provided.
 
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Brand NameSURPASS EVOLVE 4.0MM X 12MM - 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 Key12514263
MDR Text Key272746325
Report Number3008881809-2021-00390
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 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFDS40012
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 Received08/31/2021
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: 09/22/2021 Patient Sequence Number: 1
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