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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR
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STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number M003WE0300200
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2019
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during stenting of a left vertebral artery (va) stenosis, the physician experienced resistance while delivering the stent (subject device) and it could not be pushed further.During manipulation of the stent, the physician fractured the hypo tube tail of the stent delivery wire section.The physician replaced it with a new stent and completed the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the proximal end of the stabilizer was kinked, broken.The stent was also deployed from the distal end of the delivery catheter.During functional testing, the delivery catheter was flushed and lots of procedural fluid exited the device.Information available indicated that the patients anatomy was very tortuous and it is probable anatomical or procedural factors encountered during the procedure contributed to the reported event of friction.It is probable the proximal end of the stabilizer was kinked and broken as a result of handling of the device during the clinical procedure, therefore, a cause of handling damage has been assigned to this investigation.
 
Event Description
It was reported that during stenting of a left vertebral artery (va) stenosis, the physician experienced resistance while delivering the stent (subject device) and it could not be pushed further.During manipulation of the stent, the physician fractured the hypo tube tail of the stent delivery wire section.The physician replaced it with a new stent and completed the procedure without clinical consequences to the patient.
 
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Brand Name
F/G WINGSPAN STENT SYSTEM 3.0 X 20MM
Type of Device
STENT, INTRACRANIAL NEUROVASCULAR
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
MDR Report Key8951340
MDR Text Key158681934
Report Number3008881809-2019-00256
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
PMA/PMN Number
H050001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/06/2022
Device Catalogue NumberM003WE0300200
Device Lot Number21129439
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2019
Date Manufacturer Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age50 YR
Patient Weight68
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