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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 Difficult to Remove (1528); Difficult or Delayed Activation (2577); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
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. Subject device not available.
 
Event Description
It was reported that during implanting a flow diverter stent (subject device) for an aneurysm at the he the paraclinoid segment, the physician reached the mi segment of the mca (middle cerebral artery) and tried to deploy the flow diverter stent twice unsuccessfully but the straight segment the stent did not expand and the subject device was resheathed. During the 2nd try, the physician changed the way of deployment, pushing the wire, instead of a pull back maneuver but the same issue occurred. The physician tried to resheath the stent but the stent was locked into the catheter and partially deployed. The physician resheathed everything inside an intermediate catheter, getting out from the patient a distal access catheter, a microcatheter (stryker device) and the subject flow diverter stent. There were no clinical consequences to the patient.
 
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Brand NameUNKNOWN_NEUROVASCULAR_PRODUCT
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key9914361
MDR Text Key186205680
Report Number3008881809-2020-00083
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
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
Report Date 05/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/04/2020
Device Catalogue NumberUNK_NEU
Device Lot Number21361398
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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