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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD45017
Device Problem Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2019
Event Type  malfunction  
Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications. The device was returned with a stryker microcatheter. Visual inspection was performed on the returned device and it was observed that the surpass evolve flow diverter was returned deployed within the proximal end of microcatheter shaft. After removal from the microcatheter, the stent was also noted to be deformed. Also, the distal tip of the introducer sheath was damaged. During functional testing, a patency mandrel was advanced through the returned microcatheter. Further functional testing could not be performed as the flow diverter had been deployed. 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 surpass evolve introducer sheath distal tip was damaged during insertion into the microcatheter hub, causing difficulties in advancing the flow diverter and causing premature deployment of the flow diverter within the microcatheter. An assignable cause of procedural factors will be assigned to the reported and analyzed issues.
 
Event Description
Based on the return of the subject device, it was observed that the flow diverter stent was found to be deployed inside the proximal end of the microcatheter shaft during use. There were no clinical consequences to the patient.
 
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Brand NameSURPASS EVOLVE 4.5MM X 17MM - CE
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 Key10414769
MDR Text Key203161918
Report Number3008881809-2020-00240
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTR
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/04/2020
Device Catalogue NumberFD45017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2020
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

Patient Treatment Data
Date Received: 08/17/2020 Patient Sequence Number: 1
Treatment
EXCELSIOR MICROCATHETER XT-27 (STRYKER)
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