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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FDS40017
Device Problem Migration (4003)
Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Paresis (1998); Perforation of Vessels (2135); Brain Injury (2219); Loss of consciousness (2418)
Event Date 12/20/2021
Event Type  Injury  
Event Description
It was reported that during the treatment of a micro perforation at m2 of left mca, physician used the microcatheter and guidewires to deploy the subject flow diverting stent. He re -sheathed the subject stent and during deployment it was slightly migrated to forward direction while applying forward pressure to delivery system and covered the mca branch. 15 minutes post deployment physician noticed contrast leaking distal to the subject stent indicating vessel perforation. On review of imaging, it was cleared that the perforation happened before subject stent deployment and after the placement of microcatheter and guidewires. It is undeterminable if the devices caused the perforation. Balloon angioplasty was performed to stop bleeding and protamine was administered to reverse heparin. 4 hours post procedure patient started bleeding again at m1/m2 bifurcation. Another surgery was performed to remove the blood from brain and the subject stent was seen protruding from the vessel. It is undeterminable if the subject stent caused the perforation. Patient suffered paralysis and is currently in icu. No additional information available.
 
Manufacturer Narrative
One of the four mdrs. The device is not available to the manufacturer.
 
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Brand NameSURPASS EVOLVE 4.0MM X 17MM - 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 Key13310701
MDR Text Key284150390
Report Number3008881809-2022-00027
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,Followup,Followup
Report Date 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFDS40017
Device Catalogue NumberFDS40017
Device Lot Number22451788
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2020
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: 01/20/2022 Patient Sequence Number: 1
Treatment
AXS INFINITY LONG SHEATH (STRYKER); AXS VECTA INTERMEDIATE CATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR XT27 MICROCATHETER (STRYKER); SELECT CATHETER (PENUMBRA); SYNCHRO 10 GUIDEWIRE (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER)
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