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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK DEMO SURPASS EVOLVE 4.5MM X 30MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER
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STRYKER NEUROVASCULAR CORK DEMO SURPASS EVOLVE 4.5MM X 30MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number XFDS45030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative
The subject device remained inside patient.
 
Event Description
It was reported that the patient was involved in a car accident and had injuries due to car accident.The patient was having issues due to ccf (carotid-cavernous sinus fistula) prior to procedure that was being treated.The subject surpass evolve was implanted via trans femoral artery and several coils as well and 15 or so target coils were implanted via trans venous approach.The neurosurgery resident informed that the patient experienced subarachnoid hemorrhage (sah) and was brain dead the day after the procedure.On (b)(6) 2021, the patient was listed as brain dead and the patient had passed due to complication post-procedure.According to the physician, the cause of the sah and death were not determined.No one from the hospital including the physician have issued this as a product complaint.No other information was provided.
 
Event Description
It was reported that the patient was involved in a car accident and had injuries due to car accident.The patient was having issues due to ccf (carotid-cavernous sinus fistula) prior to procedure that was being treated.The subject surpass evolve was implanted via trans femoral artery and several coils as well and 15 or so target coils were implanted via trans venous approach.The neurosurgery resident informed that the patient experienced subarachnoid hemorrhage (sah) and was brain dead the day after the procedure.On (b)(6) 2021, the patient was listed as brain dead and the patient had passed due to complication post-procedure.According to the physician, the cause of the sah and death were not determined.No one from the hospital including the physician have issued this as a product complaint.No other information was provided.
 
Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Per the action required record, it was reported that the cause of sah and death were unknown.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
 
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Brand Name
DEMO SURPASS EVOLVE 4.5MM X 30MM - PMAS
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key12298498
MDR Text Key265810803
Report Number3008881809-2021-00329
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/26/2023
Device Catalogue NumberXFDS45030
Device Lot Number22413063
Was Device Available for Evaluation? No
Date Manufacturer Received10/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TARGET COILS (STRYKER)
Patient Outcome(s) Death; Other;
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