MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 2.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003WS0250200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage, Subarachnoid (1893)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 2 of the 3 reports.The subject device remains implanted.
Event or Problem Description
The patient underwent stent assisted balloon angioplasty of the basilar trunk artery stenosis with the successful implantation of the first stent (subject device).It was reported that during the placement of the second stent, the stent failed to open and hence it was not implanted.The next day of the procedure, trace amount of subarachnoid hemorrhage within interpeduncular and prepontine cistern was observed.The hemorrhage was resolved without any residual effects.No treatment was administered in the physician¿s opinion, the cause of the hemorrhage is related to the procedure; however, relationship to the stent and the balloon is unknown.
Additional Manufacturer Narrative
Executive summary corrected to clarify that the second stent delivery system was unable to reach the target lesion due to severe tortuous anatomy and the second stent was not implanted.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, hemorrhage is a known risk associated with endovascular procedure and is noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
The patient underwent stent assisted balloon angioplasty of the basilar trunk artery stenosis with the successful implantation of the first stent (subject device).It was reported that the second stent delivery system was unable to reach the target lesion due to severe tortuous anatomy and the second stent was not implanted.The next day of the procedure, trace amount of subarachnoid hemorrhage within interpeduncular and prepontine cistern was observed.The hemorrhage was resolved without any residual effects.No treatment was administered in the physician¿s opinion, the cause of the hemorrhage is related to the procedure; however, relationship to the stent and the balloon is unknown.

• Brand Name: F/G WINGSPAN STENT SYSTEM 2.5 X 20MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork CA NA
• MDR Report Key: 6874420
• Report Number: 3008853977-2017-00030
• Device Sequence Number: 636578
• Product Code: NJE
• UDI-Device Identifier: 04546540722782
• UDI-Public: (01)04546540722782(17)200531(10)19754996
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: M003WS0250200
• Device Catalogue Number: M003WS0250200
• Device Lot Number: 19754996
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 11/03/2017
• 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: Other