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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD32512
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2020
Event Type  malfunction  
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release. During visual inspection, the surpass evolve flow diverter was partially deployed from the distal tip of the microcatheter and the stent was not seated on the resheath pad. The stent was also slightly deformed at the distal end as frayed wires were present. During functional testing, the stent was not seated on the resheath pad; therefore, it was not possible to resheath the stent. The stent delivery wire (sdw) was advanced and the remainder of the stent was deployed without any issue. The reported event is covered in the device directions for use (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. Additional information provided by the customer regarding the device indicated that there was no damage noted to the packaging or system, it was confirmed that the implant and delivery wire were properly pre-loaded in the distal tip of the introducer sheath, the device was prepared as per the dfu, continuous flush was maintained throughout the procedure and the patient¿s anatomy was not tortuous. There was no resistance encountered when transferring the implant from the introducer sheath into the microcatheter. The only resistance encountered was when the physician was trying to resheath the stent, the physician felt tension and it was difficult to resheath. The stent did not fully expand and was re-captured. The device was returned and the stent was not seated on the resheath pad and there was some deformation noted to the distal end of the stent which most likely occurred as a result of excessive handling of the device during advancement/resheathing. The dislodgement of the stent from the resheath pad would have contributed to the stent failing to open up fully when unsheathed and also result in difficulties resheathing the stent. An assignable cause of procedural factors was assigned to the reported and analysed issue stent failed/unable to open (when not implanted)¿ and to the analysed issues stent partial deployment, stent difficult/unable to pull back into sheath and stent deformed 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. This is 3rd of 3 reports.
 
Event Description
Analysis of the returned device found that the stent was partially deployed. There were no clinical consequences to the patient reported as a result of this event.
 
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Brand NameSURPASS EVOLVE 3.25MM X 12MM - CE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key10798137
MDR Text Key215286601
Report Number3008881809-2020-00338
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
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 11/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/09/2021
Device Catalogue NumberFD32512
Device Lot Number22194408
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2020
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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