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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE) NTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE) NTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number UNK_NEU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Death (1802); Intracranial Hemorrhage (1891); Thrombosis (2100); Perforation of Vessels (2135); Rupture (2208); Device Embedded In Tissue or Plaque (3165)
Event Date 10/14/2019
Event Type  Death  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
The patient underwent stenting of a complex, incidental aneurysm basilar artery (ba). The aneurysm was located at the base of a ba fenestration. The treatment plan was to deliver a subject device fd (flow diverter) from the right vertebral arteries (va) into the ipsilateral branch of the ba fenestration. In a second step the plan was to position a stent from the left va into the ipsilateral branch of the ba fenestration with a microcatheter jailed within the aneurysm. The patient was under dual antiplatelet therapy (dat) with acetylsalicylic acid aspirin (ass) and clopidogrel, multiple of tests from the same day confirmed that the patient was responding to dat. In addition, 5000 i. U. Heparin were administered iv (intravenous) at the start of the procedure. The subject device fd was positioned without any difficulties with very good flow at the control digital subtraction angiography (dsa) after subject device fd placement. In addition, very good wall apposition and no signs of fish-mouthing. Swift placement of the acclino stent at the contralateral va and subsequent coiling of the aneurysm. On 2 control dsa¿s during coiling the left va as well as the acclino stent remained patent. On the third control dsa after approx. 18 coils, occlusion of the acclino stent. Catheterization of the right va. Dsa revealed occlusion of the subject device fd. Angiograms via both ica¿s displayed only sparse collateral flow via the pcom (posterior communicating artery) arteries. Again, catheterization of the right va. Angiograms in the working projection exhibited no signs of mechanical obstruction of the subject device fd. A microcatheter could be delivered through the occluded subject device subject device fd into the ba. A dsa run presented mild reconstitution of flow through the subject device fd. Catheters were removed from the right va. Administration of tirofiban iv (aggrastat). Angiographic controls via the right va 20 minutes after iv tirofiban showed re-occlusion of the subject device fd. The distal end of the subject device fd stent appeared narrowed. The subject device fd stent was then ballooned with a hyper-compliant, low-pressure balloon. During this maneuver the branch of the ba fenestration outside the subject device fd stent ruptured. The anesthesia had to be prolonged and the unknown item remained inside the patient. No other information was provided.
 
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Brand NameUNKNOWN (SURPASS STREAMLINE)
Type of DeviceNTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key9253945
MDR Text Key164630425
Report Number3008881809-2019-00325
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date05/05/2020
Device Catalogue NumberUNK_NEU
Device Lot Number21415109
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 Received01/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2019
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: 10/29/2019 Patient Sequence Number: 1
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