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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; INTRACRANIAL ANEURYSM FLOW DIVERTER
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STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number UNK_NEU
Device Problems Deformation Due to Compressive Stress (2889); Appropriate Term/Code Not Available (3191); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2020
Event Type  malfunction  
Event Description
It was reported that during the procedure, the stent (subject device) had been re-sheathed twice to reposition it distally.When trying to open the subject stent around the siphon, it ribboned.The physician attempted to reposition, re-sheath and unload tension on the system to try to manipulate the subject stent to open but it failed.The subject stent was removed successfully from the patient anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences from the patient.
 
Manufacturer Narrative
B1: adverse event/product problem: not applicable.H1: type of reportable event: not applicable.H3: device evaluated by mfg: updated.H3: summary attached: updated.D1: product long description: corrected to unknown as this product is not currently approved or commercially sold in the usa and filed as similar product to stryker device surpass streamline device.D4: lot #: corrected to unknown.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.As per the additional information, the patients anatomy was moderately tortuous.The flow diverter stent was returned for analysis and it was found to be deformed.It is probable that the device was deformed during advancement through the patients anatomy causing the difficulty for the flow diverter to fully open.An assignable cause of procedural factors will be assigned to the reported and analyzed issues as the issue is 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.Non-reportable rationale: based on further review, the reported event description, the subject flow diverter failed to open but was recaptured by the operator and successfully removed from the patient¿s body.The physician did not take any action/ intervention due to this event.There was no reported permanent impairment of a body function or permanent damage to a body structure, no medical or surgical intervention to prevent permanent impairment of a body function or structure was performed and the event was not life threatening.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the subject device.The neurovascular stryker surpass evolve device is not currently 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 during the procedure, the stent (subject device) had been re-sheathed twice to reposition it distally.When trying to open the subject stent around the siphon, it ribboned.The physician attempted to reposition, re-sheath and unload tension on the system to try to manipulate the subject stent to open but it failed.The subject stent was removed successfully from the patient anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences from the patient.
 
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Brand Name
UNKNOWN_NEUROVASCULAR_PRODUCT
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 Key9863078
MDR Text Key184509098
Report Number3008881809-2020-00071
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
Report Date 04/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_NEU
Device Lot Number21668048
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2020
Date Manufacturer Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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