MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF NEUROFORM 3- 4.0 X 20MM; STENT, INTRACRANIAL NEUROVASCULAR

Model Number	M003SNF340200
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during procedure the resistance was encountered and the outer delivery catheter of the system broke away from the proximal hub.The stent was safely removed from the patient as one unit and the procedure was completed without the stent.There were no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
Updated - product returned and date received.Device evaluated: updated.Expiration date: added.Manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Upon visual inspection, the stent stabilizer was kinked from the distal to the hub and blood was observed in the hub.The microcatheter shaft was stretched and kinked at 18cm from the distal end.The microcatheter shaft was noted to be bunched up under the secondary strain relief and it was broken/ fractured from 5mm  25mm from the secondary strain relief.The returned stent was deployed and noted to be deformed.During functional evaluation, the pusher stabilizer was flushed without difficulty.However; the stabilizer was unable to be advanced or retracted through the microcatheter.The microcatheter was unable to be flushed.The microcatheter was cut in an attempt to identify the root cause the reported event.The catheter was then flushed again and blood exited at the distal end.Based on analysis of the device and available information indicated that the patients anatomy was moderately to fairly tortuous.The returned device was damaged and blood was noted within the returned microcatheter which could be contributory factors to the reported event along with the tortuous anatomy.An assignable cause of operational context was assigned to the reported event.
Event or Problem Description
It was reported that during procedure the resistance was encountered and the outer delivery catheter of the system broke away from the proximal hub.The stent was safely removed from the patient as one unit and the procedure was completed without the stent.There were no clinical consequences to the patient due to this event.

• Brand Name: NEUROFORM 3- 4.0 X 20MM
• Common Device Name: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 6756023
• Report Number: 3008881809-2017-00229
• Device Sequence Number: 162680
• Product Code: NJE
• UDI-Device Identifier: 07613252193890
• UDI-Public: (01)07613252193890(17)190531(10)19107860
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: H020002
• 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): 10/18/2017

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: 05/31/2019
• Device Model Number: M003SNF340200
• Device Catalogue Number: M003SNF340200
• Device Lot Number: 19107860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1