MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK NEUROFORM 3- 4.5 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number	M003SNF345200
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The microdelivery catheter, stabilizer catheter and stent were returned still assembled.Visual and microscopic inspection of the returned device found that the stabilizer catheter was kinked most likely caused by the handling of the device.There was also a kinked unknown guidewire loaded into the device and protruding from the distal end.The guidewire was noted to be stuck within the stabilizer catheter and was unable to be removed.There was blood noted on the guidewire and the delivery microcatheter.The system was flushed and an attempt was made to move the stabilizer catheter within the microdelivery catheter.There was a high volume of blood noted on the device and the stent was stuck to the stabilizer catheter due to the dried blood.The stent was immersed in saline and was released from the stabilizer catheter.The stent was able to be deployed out with high friction noted but was unable to open and required manipulation by the investigator to open fully due to the presence of blood.It is likely that some procedural factors encountered during the procedure limited the performance of the device contributed to the event.Therefore, an assignable cause of operational context has been assigned to the observed stent inability to open.
Event or Problem Description
Analysis of the returned device found that the stent was unable to open.There was no clinical consequence to the patient.

• Brand Name: NEUROFORM 3- 4.5 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: 5693217
• Report Number: 3008881809-2016-00016
• Device Sequence Number: 13460614
• Product Code: NJE
• UDI-Device Identifier: 07613252193937
• UDI-Public: (01)07613252193937(17)170930(10)17969069
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: H020002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2017
• Device Catalogue Number: M003SNF345200
• Device Lot Number: 17969069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2016
• Initial Report FDA Received Date: 06/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1