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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 5X20 INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS 5X20 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number M003124FPP0
Device Problem Activation Failure (3270)
Patient Problems Aneurysm (1708); Stenosis (2263); Vascular Dissection (3160)
Event Date 04/11/2018
Event Type  Injury  
Manufacturer Narrative
This is 2 of the 2 reports for this event. The device remains in patient.
 
Event Description
It was reported that approximately 16 months after the procedure for the aneurysm at the right internal carotid, digital subtraction angiography (dsa) showed a non-optimal position of the fusiform aneurysm component of the internal carotid artery (ica) after dissection, provided by the flow diverter. Then approximately 2 months later, a percutaneous transluminal angioplasty (pta) of the flow diverter was performed several times to treat the dissection aneurysm. Good dilation result showed in the proximal flow diverter section, however no relevant enhancement in the distal end. Approximately 2 years after the initial procedure, dsa showed the depletion of the proximal lumen of the flow diverter increased again compared to right after the pta. And the flow diverter tapered lute-like towards the proximal end. The remaining partly incomplete wall adaption of the flow diverter with sufficient lumen and flow was not changed, not progressive. Intracranial perfusion also appeared unchanged and unaffected. In the physician¿s opinion, the event was related to the implanted flow diverter.
 
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Brand NameSURPASS 5X20
Type of DeviceINTRACRANIAL 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 Key8419017
MDR Text Key138759006
Report Number3008881809-2019-00071
Device Sequence Number0
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
Report Date 04/22/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberM003124FPP0
Device Lot Number18849697
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 Received04/18/2019
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: 03/13/2019 Patient Sequence Number: 1
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