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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE); INTRACRANIAL ANEURYSM FLOW DIVERTER
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STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE); INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD40020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)
Event Date 06/13/2019
Event Type  Injury  
Manufacturer Narrative
The subject device remains implanted.
 
Event Description
It was reported that the patient presented to the hospital for an elective procedure for aneurysm located in the internal carotid artery (ica).The patient had severely tortuous anatomy.A stent was used to straight the microcatheter and then the subject flow diverter was deployed successfully.On the final angiography run, it was noticed that the distal vessel had a slow flow.A computed tomography (ct) scan was performed but the images were not clear.Integrilin was administered; however, on the angiography run it was noticed that there was a subarachnoid hemorrhage (sah) in the distal vasculature.The physician applied a little glue to treat the ruptured vessel.No other information was provided.
 
Event Description
It was reported that the patient presented to the hospital for an elective procedure for aneurysm located in the internal carotid artery (ica).The patient had severely tortuous anatomy.A stent was used to straight the microcatheter and then the subject flow diverter was deployed successfully.On the final angiography run, it was noticed that the distal vessel had a slow flow.A computed tomography (ct) scan was performed but the images were not clear.Integrilin was administered; however, on the angiography run it was noticed that there was a subarachnoid hemorrhage (sah) in the distal vasculature.The physician applied a little glue to treat the ruptured vessel.No other information was provided.
 
Manufacturer Narrative
Product long description: unknown (surpass streamline).Catalog#: unknown.Lot/serial no.: unknown.The neurovascular stryker surpass evolve device is not currently not approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024).See section 4.11.3 guidance for industry and food and drug administration staff, november 8, 2016.
 
Event Description
It was reported that the patient presented to the hospital for an elective procedure for aneurysm located in the internal carotid artery (ica).The patient had severely tortuous anatomy.A stent was used to straight the microcatheter and then the subject flow diverter was deployed successfully.On the final angiography run, it was noticed that the distal vessel had a slow flow.A computed tomography (ct) scan was performed but the images were not clear.Integrilin was administered; however, on the angiography run it was noticed that there was a subarachnoid hemorrhage (sah) in the distal vasculature.The physician applied a little glue to treat the ruptured vessel.No other information was provided.
 
Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, the a product related root cause does not apply and the reported issue is due to a known physiological effect of the procedure and/or patient condition noted with the direction for use, product labelling and/or risk documentation files; therefore, an assignable cause of anticipated procedural complication was assigned to the as reported issues patient intracranial hemorrhage and patient vessel perforation.
 
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Brand Name
UNKNOWN (SURPASS STREAMLINE)
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key8745594
MDR Text Key149554995
Report Number3008881809-2019-00187
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/24/2020
Device Catalogue NumberFD40020
Device Lot Number21323883
Was Device Available for Evaluation? No
Date Manufacturer Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Weight60
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