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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 Problem Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/06/2020
Event Type  malfunction  
Manufacturer Narrative
Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release. The device was returned with an xt-27 microcatheter. Visual inspection was performed on the returned device and it was observed that the distal 6cm section of the returned xt-27 microcatheter was broken/fractured and flattening/crushing noted to the distal 15cm of the microcatheter. During functional testing, a patency mandrel was advanced through the returned xt-27 and the surpass evolve flow diverter was removed from the microcatheter. The surpass evolve flow diverter was found to be deployed and deformed within the xt-27 microcatheter lumen. The reported event was confirmed. The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device. 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 xt-27 microcatheter was damaged during the clinical procedure causing difficulties in deploying the flow diverter and causing premature deployment of the flow diverter within the xt-27 during the attempt to remove from the patient. An assignable cause of caused by other will be assigned to the reported and analyzed issues. 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. This is the first of 2 reports.
 
Event Description
Based on the return of the devices, it was observed that the stent (subject device) was prematurely deployed inside the flattened and broken catheter. 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 Key10012265
MDR Text Key189494125
Report Number3008881809-2020-00122
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeDE
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 04/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_NEU
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? Yes
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: 04/29/2020 Patient Sequence Number: 1
Treatment
EXCELSIOR XT-27 MICROCATHETER
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