MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003WS0350200
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post stent deployment, the inner body tapered tip of the stent delivery system, got caught with the stent.As the stent delivery system was being pulled back, the stent started to move.The physician advanced an intermediate catheter over the stent delivery system successfully releasing the inner body tapered tip from the stent without clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the device revealed that the outer body catheter was compressed and wrinkled and the inner body was compressed and kinked as well.Blood was observed to be on the dual tapered tip.During functional evaluation the inner body was held stationary and the outer body was withdrawn.There was a lot of friction while the outer body was being withdrawn.The anomalies found on the outer body are known to adversely affect the functional performance of the product.The stent was not in the outer body nor it was returned.Information available indicated that resistance was experienced during deployment of the stent.The reported and observed issues are indicative of high friction during deployment.The exact cause of high friction during deployment cannot be definitively determined in this case.Identified possible causes are: highly tortuous anatomy; inadequate flush; a locked rhv; a steam shaped tip or the tip being locked in the outer body.Because of the high friction, the user may have applied excessive force between the inner and the catheter in an effort to deploy the stent.This tensile force in the catheter can cause damages to the microcatheter, and the corresponding compressive force in the inner can cause compression the inner, which may manifest itself as buckling, bending, and possibly kinking and breakage.There is no indication of tortuous anatomy, a locked rhv, steam shaped tip or the tip being locked in the outer body.The blood observed on the dual tapered tip is in indication that continuous flush was not maintained; however, this could not be definitively determined based on the information available.Therefore, the cause for the reported event and observed findings cannot be determined.
Event or Problem Description
It was reported that post stent deployment, the inner body tapered tip of the stent delivery system, got caught with the stent.As the stent delivery system was being pulled back, the stent started to move.The physician advanced an intermediate catheter over the stent delivery system successfully releasing the inner body tapered tip from the stent without clinical consequences to the patient.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.5 X 20MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5672849
• Report Number: 3008881809-2016-00005
• Device Sequence Number: 13506223
• Product Code: NJE
• UDI-Device Identifier: 04546540722843
• UDI-Public: (01)04546540722843(17)180731(10)18527736
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2018
• Device Catalogue Number: M003WS0350200
• Device Lot Number: 18527736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2016
• Supplement Report FDA Received Date: 10/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention