MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 2.5 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003WS0250150
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Hemorrhage, Subarachnoid (1893)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of 3 reports.The subject device is not availabe.
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.It was reported that during the placement of the second stent (subject device), 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 is updated to clarify that the stent was not deployed due to anatomy.Expiration date: added.Manufacturing date: added.Patient code: correction as code for hemorrhage is not applicable anymore.Device code: correction as deployment code is not applicable any more as the stent was not deployed.Further review of the event confirmed that the second stent did not reach the target lesion and was not able to be deployed due to anatomy.The physician did not take any action/ intervention due to this event.There was no reported permanent impairment of a body function or permanent damage to a body structure, no medical or surgical intervention to prevent permanent impairment of a body function or structure was performed and the event was not life threatening.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
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.It was reported that the second stent (subject device) was not able to deploy due to anatomy.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 15MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6853832
• Report Number: 3008881809-2017-00302
• Device Sequence Number: 60374
• Product Code: NJE
• UDI-Device Identifier: 04546540722775
• UDI-Public: (01)04546540722775(17)171130(10)18085708
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: M003WS0250150
• Device Catalogue Number: M003WS0250150
• Device Lot Number: 18085708
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 11/21/2017
• 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
• Patient Age: 49 YR