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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 UNK_NEU
Device Problems Premature Activation (1484); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2019
Event Type  malfunction  
Manufacturer Narrative
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.Corrections: lot/serial no.: unknown.The subject device is not available to the manufacturer yet.
 
Event Description
It was reported that the subject stent flow diverter failed to open adequately during deployment, so the physician decided to withdraw the subject stent from the micro catheter, but the stent prematurely deployed inside the micro catheter.The physician withdrew the stent and micro catheter together.The aneurysm was bypassed with another micro catheter and a different size stent was deployed to complete the procedure successfully.There were no reported clinical consequences to the patient.
 
Event Description
It was reported that the subject stent flow diverter failed to open adequately during deployment, so the physician decided to withdraw the subject stent from the micro catheter, but the stent prematurely deployed inside the micro catheter.The physician withdrew the stent and micro catheter together.The aneurysm was bypassed with another micro catheter and a different size stent was deployed to complete the procedure successfully.There were no reported clinical consequences to the patient.
 
Manufacturer Narrative
H3 device evaluated by mfg - updated.H3 summary attached - updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned.Therefore, visual and functional analysis were not performed.The reported event is covered in the device 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.The good faith effort attempts have been completed in our effort to obtain the device and answers to follow up questions issued.However, as of today, no additional information or product have been received; therefore, the investigation was proceeded with the information currently available.While there are several potential causes for the reported issues, because review and analysis of available information failed to identify a definitive cause, and because the device was not returned a cause of undeterminable was assigned.H3 other text : the subject device is not available to the manufacturer.
 
Event Description
It was reported that the subject stent flow diverter failed to open adequately during deployment, so the physician decided to withdraw the subject stent from the micro catheter, but the stent prematurely deployed inside the micro catheter.The physician withdrew the stent and micro catheter together.The aneurysm was bypassed with another micro catheter and a different size stent was deployed to complete the procedure successfully.There were no reported clinical consequences to the patient.
 
Manufacturer Narrative
D10/h3 product available to stryker - updated d11 concomitant products grid - added h3 device evaluated by mfg - updated h3 summary attached - updated due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was returned with an xt-27 microcatheter and the reported lot number was confirmed from the returned packaging.Visual analysis revealed that the sdw was returned within the introducer sheath, slight bending was noted to the distal end of the sdw and the flow diverter was not located within the introducer sheath.Functional analysis could not be performed as the stent had been deployed.The stent was found to be deployed within the returned xt-27 microcatheter during a patency test, and the distal end of the flow diverter was noted to be deformed.The reported event is covered in the device 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.It is probable that the device was damaged during advancement during the clinical procedure and was unable to open during the deployment attempt, the stent was subsequently deployed within the xt-27 during removal from the patient.Therefore, an assignable cause of procedural factors will be assigned to the reported event of stent failed/ unable to open and stent deployed prematurely during use, as the issues are associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu, but due to procedural and/or anatomical factors during use, the product performance was limited.
 
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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
IE  NA
MDR Report Key9380063
MDR Text Key168815188
Report Number3008881809-2019-00371
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 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_NEU
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2020
Date Manufacturer Received01/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
XT-27 MICRO CATHETER(STRYKER); XT-27 MICROCATHETER(STRYKER)
Patient Age58 YR
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