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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 15MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 15MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD32515
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2020
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. The device was returned with an xt-27 micro catheter and a second surpass evolve flow diverter system. The reported lot number was confirmed from the returned packaging. On visual inspection, the surpass evolve flow diverter stent was inspected and one of the ends was slightly frayed. The sdw was inspected and no anomaly was noted. The xt-27 micro catheter shaft was inspected and the distal end was flattened/crushed. Functional testing was not performed as the micro catheter shaft was deformed and the stent had already been deployed it was not possible to re sheath the stent. The reported event was confirmed during the device analysis. 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 indicated that the device was confirmed to be in good condition prior to use and the device was prepared/set up as per the directions for use. Continuous flush was maintained for the duration of the procedure. The introducer sheath was properly inserted all the way into the micro catheter prior to transfer, while the introducer sheath was seated at the hub, the rhv was opened enough to allow passage of the device through without damage, when advancing the coil within the xt-27 micro catheter, the rhv was opened enough to allow passage of the device through without damage, excessive force was not applied at any point while advancing the coil within the micro catheter and the patient¿s anatomy was mildly tortuous. As the device would not re-sheath, it was discarded a new device and xt-27 micro catheter were used to finish the procedure. There was a surgical delay of 10 minutes as a new device and micro catheter had to be opened and replaced the device which would not re sheath. The event description relates to pr 2530526 but this additional surpass evolve flow diverter system was also returned with the complaint. However, it is unclear what was the issue with this returned device. Attempts were made to obtain information related to this device without success. Product analysis found fraying at one end of the returned stent which indicates it encountered a force possibly as a result of attempting to recapture the stent back into the flattened/crushed xt-27 micro catheter shaft however this cannot be confirmed. An assignable cause of procedural factors will be assigned to the reported device problem unknown/unclear and to the analyzed stent deformed and flow diverter stent difficult/unable to re-capture into micro catheter 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.
 
Event Description
It was reported that during the procedure, the physician was unable re sheath the subject stent while trying to deploy the subject stent inside the patient. The subject device was replaced, and procedure was completed without clinical consequence to the patient. Analysis of the device revealed that the subject flow diverting stent failed to recapture into the micro catheter; therefore, based on this information the event is deemed reportable.
 
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Brand NameSURPASS EVOLVE 3.25MM X 15MM - 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 Key11141060
MDR Text Key231172167
Report Number3008881809-2021-00019
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 01/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/17/2020
Device Catalogue NumberFD32515
Device Lot Number21949790
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2019
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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