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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 Problems Difficult to Remove (1528); Difficult or Delayed Activation (2577); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
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.Subject device not available.
 
Event Description
It was reported that during implanting a flow diverter stent (subject device) for an aneurysm at the he the paraclinoid segment, the physician reached the mi segment of the mca (middle cerebral artery) and tried to deploy the flow diverter stent twice unsuccessfully but the straight segment the stent did not expand and the subject device was resheathed.During the 2nd try, the physician changed the way of deployment, pushing the wire, instead of a pull back maneuver but the same issue occurred.The physician tried to resheath the stent but the stent was locked into the catheter and partially deployed.The physician resheathed everything inside an intermediate catheter, getting out from the patient a distal access catheter, a microcatheter (stryker device) and the subject flow diverter stent.There were no clinical consequences to the patient.
 
Manufacturer Narrative
D4: expiration date: updated d10: product available to stryker: updated h3: device evaluated by mfg: updated h3: summary attached: updated h4: manufacturing date: updated h6: device code: corrected 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 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.The device was returned inserted in the concurrent microcatheter and it was confirmed that the stent was partially deployed.The subject device was advanced, the stent was removed, and was noted to be damaged.The concurrent microcatheter was noted to be severely damaged mid shaft to the distal shaft and the catheter tip was also damaged.The subject stent stabilizer could not be removed from the microcatheter due to the extensive damage noted to the microcatheter.It is probable that the device was damaged during the clinical procedure causing the difficulty for the flow diverter to open.An assignable cause of procedural factors will be assigned to the reported and analyzed defects 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 implanting a flow diverter stent (subject device) for an aneurysm at the he the paraclinoid segment, the physician reached the mi segment of the mca (middle cerebral artery) and tried to deploy the flow diverter stent twice unsuccessfully but the straight segment the stent did not expand and the subject device was resheathed.During the 2nd try, the physician changed the way of deployment, pushing the wire, instead of a pull back maneuver but the same issue occurred.The physician tried to resheath the stent but the stent was locked into the catheter and partially deployed.The physician resheathed everything inside an intermediate catheter, getting out from the patient a distal access catheter, a microcatheter (stryker device) and the subject flow diverter stent.There were no clinical consequences to the patient.
 
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Brand Name
UNKNOWN_NEUROVASCULAR_PRODUCT
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key9914361
MDR Text Key186205680
Report Number3008881809-2020-00083
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/04/2020
Device Catalogue NumberUNK_NEU
Device Lot Number21361398
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2020
Date Manufacturer Received05/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXCELSIOR XT27 MICROCATHETER (STRYKER)
Patient Age52 YR
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