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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER
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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FD40015
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2020
Event Type  Injury  
Manufacturer Narrative
The subject device is unavailable to manufacturer.
 
Event Description
It was reported that during a second attempt of stent (subject device) distal deployment, the subject device stent could not open at the curve.After many manipulations, the physician tried to release tension from the system, unfortunately, the pad which allows the resheath of the subject sent was dislodged from the stent.After the physician was not able to resheath the subject stent in the microcatheter, the whole system was removed with a snare device.The procedure was completed with new competitor stent without clinical consequences to the patient.No other information was provided.
 
Manufacturer Narrative
Adverse event/product problem - corrected - removed product problem.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was returned with a catalyst intermediate / guide catheter and a codman catheter which appears to have been used to advance the snare device.The subject stent was crushed at the proximal end with the braid frayed at both the proximal and distal ends and the sdw was kinked towards the distal end but not broken which indicates the device experienced a significant force as a result of repeated attempts at re-capturing the subject stent in the xt-27 microcatheter.Functional test could not be performed as the subject stent was deformed.The reported complaint was confirmed based on analysis.The subject device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.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 there was no damage noted to the packaging prior to opening the packaging, the subject stent device was confirmed to be in good condition during preparation/prior to use on the patient and the subject device was prepared for use as per the directions for use (dfu).Continuous flush was maintained throughout the clinical procedure.The subject stent device was used with an xt-27 microcatheter, the catheter tip was not shaped and in the physician¿s opinion, the xt-27 catheter device performed as intended.The patient¿s anatomy was moderately tortuous.There was no resistance encountered advancing the implant from the introducer sheath into the microcatheter and no resistance encountered when advancing the system through the microcatheter, the mid part of the subject stent device failed to open in the carotid siphon.Between 5 and 6 attempts to resheath the subject stent device into the microcatheter, in order to try to open the subject stent device in the curve, the doctor has to resheath subject stent device and remove the tension of system several times.It is important to note, when the subject stent device did not open in the curve and at the moment it was displaced to the pad, the tip of microcatheter had not reached the point of no return.The proximal part of the subject stent device was displaced and was no longer attached to the resheath pad.The fact that the subject stent device was no longer attached to the pad, made it impossible to resheath the subject stent device into its microcatheter.There was a surgical delay of 1 hour and there were no other adverse consequences to the patient.An assignable cause of procedural factors will be assigned to the reported and analysed ¿stent failed/unable to open (when not implanted)¿ and ¿stent difficult/unable to pull stent back into sheath¿ and to the analysed ¿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.An assignable cause of not confirmed will be assigned to the reported ¿sdw broken/fractured during use¿ as the sdw was not returned for analysis and the defect could not be confirmed.
 
Event Description
It was reported that during a second attempt of stent (subject device) distal deployment, the subject device stent could not open at the curve.After many manipulations, the physician tried to release tension from the system, unfortunately, the pad which allows the resheath of the subject sent was dislodged from the stent.After the physician was not able to resheath the subject stent in the microcatheter, the whole system was removed with a snare device.The procedure was completed with new competitor stent without clinical consequences to the patient.No other information was provided.
 
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Brand Name
SURPASS EVOLVE 4.0MM X 15MM - CE
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
MDR Report Key10841898
MDR Text Key216309052
Report Number3008881809-2020-00346
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/21/2021
Device Catalogue NumberFD40015
Device Lot Number22320439
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2020
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MICROCATHETER:XT-27 (STRYKER).; MICROCATHETER:XT-27 (STRYKER)
Patient Outcome(s) Required Intervention;
Patient Age49 YR
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