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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK 5 X 50 SURPASSTM SYSTEM INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK 5 X 50 SURPASSTM SYSTEM INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number 123FPP
Device Problem Difficult or Delayed Activation (2577)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Date 10/25/2018
Event Type  Injury  
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications. Visual examination of the returned device revealed that the stent the flow diverter stent was fully opened. There was some deformation noted to the distal end of the flow diverter. The stabilizer was kinked at 27cm from the proximal end. The stabilizer was kinked at 28. 5cm from the distal end. During functional testing, the delivery catheter was flushed without difficulty. The stabilizer was able to be advanced ad removed from the catheter without difficulty. The stabilizer was noted to be kinked as per visual inspection above. The damage noted to the returned device is indicative of the as reported event. It is probable that the device was damaged during the clinical procedure causing the partial deployment of the flow diverter. An assignable cause of procedural factors will be assigned to the reported stent partial deployment and to the analyzed stent prematurely deployed outside patient, stent deformed and, stent stabilizer kinked. Therefore, an assignable cause of procedural factors has been assigned to as reported stent failure to open, stent delivery wire stuck in the stent, and the analyzed stent failure to open, stent deformed, catheter shaft blocked/occluded and stent stabilizer/catheter friction. It cannot be determined that the reported patient complications (hemi-paresis) is related to the device. However, neurological deficit, in this case hemiparesis is a known risk associated with endovascular procedures and are noted as such in the device directions for use (dfu). Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.
 
Event Description
It was reported that during procedure a first flow diverter stent did not open and seemed "stuck" to the pusher wire. The stent was removed from the patient¿s body and replaced by a second flow diverter stent (second subject device). The second stent did not open distally and partially deployed. It was removed from the patient¿s body and replaced by a third non-stryker flow diverter that was implanted successfully. The patient was woken and started to present with a hemiparesis that was resolved approximately 1 week later. According to the physician, the relationship of the hemiparesis to any device is unknown.
 
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Brand Name5 X 50 SURPASSTM SYSTEM
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 Key8269934
MDR Text Key133857096
Report Number3008881809-2018-00493
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
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/24/2021
Device Catalogue Number123FPP
Device Lot Number20367173
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2018
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: 01/23/2019 Patient Sequence Number: 1
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